{"protocolSection":{"identificationModule":{"nctId":"NCT00683800","orgStudyIdInfo":{"id":"3151A2-3353"},"secondaryIdInfos":[{"id":"B2061011"}],"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women","officialTitle":"A Double-Blind, Randomized, Placebo-Controlled Study Assessing The Safety And Efficacy Of DVS SR For The Treatment Of Vasomotor Symptoms Associated With Menopause"},"statusModule":{"statusVerifiedDate":"2011-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-06"},"primaryCompletionDateStruct":{"date":"2010-05","type":"ACTUAL"},"completionDateStruct":{"date":"2010-05","type":"ACTUAL"},"studyFirstSubmitDate":"2008-05-21","studyFirstSubmitQcDate":"2008-05-22","studyFirstPostDateStruct":{"date":"2008-05-23","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-04-21","resultsFirstSubmitQcDate":"2011-07-21","resultsFirstPostDateStruct":{"date":"2011-08-17","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-07-21","lastUpdatePostDateStruct":{"date":"2011-08-17","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Director, Clinical Trial Disclosure Group","oldOrganization":"Pfizer, Inc"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of the study is to evaluate the efficacy and safety of Desvenlafaxine Succinate (DVS) Sustained Release (SR), in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) in menopausal women."},"conditionsModule":{"conditions":["Vasomotor Symptoms"],"keywords":["Menopause","Hot Flush","Hot Flash","Desvenlafaxine succinate Sustained Release"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":2186,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1","type":"EXPERIMENTAL","description":"desvenlafaxine succinate (DVS) SR","interventionNames":["Drug: desvenlafaxine succinate (DVS) SR"]},{"label":"2","type":"PLACEBO_COMPARATOR","description":"Placebo","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"desvenlafaxine succinate (DVS) SR","description":"Titration with 50 mg tablets once daily for 7 days, then 100mg tablets once daily from day 8 to day 365, then taper with 50 mg tablets once daily for 7 days, followed by 25 mg tablets once daily for 7 days.","armGroupLabels":["1"]},{"type":"DRUG","name":"Placebo","description":"Titration with 50 mg placebo tablets once daily for 7 days, then 100mg placebo tablets once daily from day 8 to day 365, then taper with 50 mg placebo tablets once daily for 7 days, followed by 25 mg placebo tablets once daily for 7 days.","armGroupLabels":["2"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4","description":"The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.","timeFrame":"Baseline and Week 4"},{"measure":"Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12","description":"The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.","timeFrame":"Baseline and Week 12"},{"measure":"Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4","description":"Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1\\*Number of mild+2\\*Number of moderate+3\\*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.","timeFrame":"Baseline and Week 4"},{"measure":"Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12","description":"Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1\\*Number of mild+2\\*Number of moderate+3\\*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.","timeFrame":"Baseline and Week 12"},{"measure":"Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events","description":"Adjudicated ischemic cardiovascular events were a composite of: a) Coronary Heart Disease (CHD)-related death; b) New Myocardial Infarction (MI) (non-procedure-related MI); c) Documented new onset of unstable angina requiring hospitalization; d) Unscheduled coronary revascularization procedures (percutaneous coronary intervention) or bypass grafting.","timeFrame":"Baseline up to Month 12"}],"secondaryOutcomes":[{"measure":"Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes","description":"A mean decrease from baseline of at least 5.35 moderate to severe hot flushes at week 12 in the participants was considered clinically meaningful.","timeFrame":"Baseline and Week 12"},{"measure":"Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes","description":"The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.","timeFrame":"Baseline, Week 4 and Week 12"},{"measure":"Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes","description":"The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.","timeFrame":"Baseline, Week 4 and Week 12"},{"measure":"Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes","description":"Time to response was defined as the time-to-first 50% reduction in the average daily number of moderate to severe hot flushes over 3 consecutive days.","timeFrame":"Week 12"},{"measure":"Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12","description":"The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. Adjusted mean was calculated by using change from baseline as response variable, treatment as factor, and baseline as covariate using the observed cases.","timeFrame":"Baseline, Month 6 and Month 12"},{"measure":"Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12","description":"Severity: mild (heat sensation without sweating); moderate (heat sensation with sweating; able to continue activity); severe (heat sensation with sweating; causing cessation of activity). Average daily severity of hot flushes= (1\\*Number of mild+2\\*Number of moderate+3\\*Number of severe)/(Total number of hot flushes). Days with no hot flushes: severity score=0. As it was derived from count data, there was no maximum; minimum score=0; higher values= worse outcomes. Adjusted mean: calculated using change from baseline=response variable, treatment=factor and baseline=covariate using observed cases.","timeFrame":"Baseline, Month 6 and Month 12"},{"measure":"Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12","description":"GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms \\[range 0-33\\], anxiety \\[range 0-18\\], depression \\[range 0-15\\], somatic symptoms \\[range 0-21\\], vasomotor symptoms \\[range 0-6\\], and sexual dysfunction \\[range 0-3\\]). A decrease in the total climacteric score indicated an improvement in symptoms.","timeFrame":"Baseline and Week 12"},{"measure":"Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6","description":"GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms \\[range 0-33\\], anxiety \\[range 0-18\\], depression \\[range 0-15\\], somatic symptoms \\[range 0-21\\], vasomotor symptoms \\[range 0-6\\], and sexual dysfunction \\[range 0-3\\]). A decrease in the total climacteric score indicated an improvement in symptoms.","timeFrame":"Baseline and Month 6"},{"measure":"Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12","description":"GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms \\[range 0-33\\], anxiety \\[range 0-18\\], depression \\[range 0-15\\], somatic symptoms \\[range 0-21\\], vasomotor symptoms \\[range 0-6\\], and sexual dysfunction \\[range 0-3\\]). A decrease in the total climacteric score indicated an improvement in symptoms.","timeFrame":"Baseline and Month 12"},{"measure":"Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12","description":"PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).","timeFrame":"Week 12"},{"measure":"Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6","description":"PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).","timeFrame":"Month 6"},{"measure":"Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12","description":"PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).","timeFrame":"Month 12"},{"measure":"Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12","description":"PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).","timeFrame":"Week 12"},{"measure":"Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6","description":"PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).","timeFrame":"Month 6"},{"measure":"Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12","description":"PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).","timeFrame":"Month 12"},{"measure":"Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12","description":"PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).","timeFrame":"Week 12"},{"measure":"Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6","description":"PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).","timeFrame":"Month 6"},{"measure":"Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12","description":"PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).","timeFrame":"Month 12"},{"measure":"Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12","description":"PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).","timeFrame":"Week 12"},{"measure":"Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6","description":"PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).","timeFrame":"Month 6"},{"measure":"Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12","description":"PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).","timeFrame":"Month 12"}],"otherOutcomes":[{"measure":"Number of Participants With Adjudicated Cerebrovascular Events - Any Stroke","description":"Adjudicated cerebrovascular events were identified using Standardized MedDRA Query (SMQ), for \"central nervous system haemorrhages and cerebrovascular conditions\". Primary assessments included: 1) definite stroke, 2) probable stroke, 3) probable transient ischemic attack (TIA), and 4) no stroke or TIA.","timeFrame":"Baseline up to Month 12"},{"measure":"Number of Participants With Adjudicated Cerebrovascular Events - Probable TIA","description":"Adjudicated cerebrovascular events were identified using Standardized MedDRA Query (SMQ), for \"central nervous system haemorrhages and cerebrovascular conditions\". Primary assessments included: 1) definite stroke, 2) probable stroke, 3) probable transient ischemic attack (TIA), and 4) no stroke or TIA.","timeFrame":"Baseline up to Month 12"},{"measure":"Number of Participants With Ischemic Heart Disease","description":"Potential ischaemic cardiac events were identified using the Standardized MedDRA Query (SMQ) \"Ischemic Heart Disease\".","timeFrame":"Baseline up to Month 12"},{"measure":"Number of Participants With Hepatic Events","description":"Hepatic events were defined as incidence of increased Liver Function Test (AST \\[aspartate aminotransferase\\] or ALT \\[alanine aminotransferase\\]) levels greater than 5 times the ULN (upper limit of normal).","timeFrame":"Baseline up to Month 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Generally healthy, postmenopausal women who seek treatment for hot flushes\n* Body Mass Index (BMI) less than or equal to 34 kg/m\\^2\n\nExclusion Criteria:\n\n* Hypersensitivity to Venlafaxine\n* Myocardial infarction an/or unstable angina within 6 months of screening\n* History of seizure disorder","healthyVolunteers":true,"sex":"FEMALE","minimumAge":"45 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Pfizer Investigational Site","city":"Birmingham","state":"Alabama","zip":"35235","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Pfizer Investigational Site","city":"Mobile","state":"Alabama","zip":"36608","country":"United States","geoPoint":{"lat":30.69436,"lon":-88.04305}},{"facility":"Pfizer Investigational Site","city":"Montgomery","state":"Alabama","zip":"36106","country":"United States","geoPoint":{"lat":32.36681,"lon":-86.29997}},{"facility":"Pfizer Investigational Site","city":"Glendale","state":"Arizona","zip":"85308","country":"United States","geoPoint":{"lat":33.53865,"lon":-112.18599}},{"facility":"Pfizer Investigational Site","city":"Peoria","state":"Arizona","zip":"85381","country":"United States","geoPoint":{"lat":33.5806,"lon":-112.23738}},{"facility":"Pfizer Investigational Site","city":"Tucson","state":"Arizona","zip":"85710","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"facility":"Pfizer Investigational Site","city":"Tucson","state":"Arizona","zip":"85712","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"facility":"Pfizer Investigational Site","city":"Tucson","state":"Arizona","zip":"85715","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"facility":"Pfizer Investigational Site","city":"Jonesboro","state":"Arkansas","zip":"72401","country":"United States","geoPoint":{"lat":35.8423,"lon":-90.70428}},{"facility":"Pfizer Investigational Site","city":"Little Rock","state":"Arkansas","zip":"72205","country":"United States","geoPoint":{"lat":34.74648,"lon":-92.28959}},{"facility":"Pfizer Investigational Site","city":"Little Rock","state":"Arkansas","zip":"72223","country":"United States","geoPoint":{"lat":34.74648,"lon":-92.28959}},{"facility":"Pfizer Investigational Site","city":"San Diego","state":"California","zip":"92103","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Pfizer Investigational Site","city":"San Diego","state":"California","zip":"92108","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Pfizer Investigational Site","city":"San Diego","state":"California","zip":"92123","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Pfizer Investigational Site","city":"Vista","state":"California","zip":"92083","country":"United States","geoPoint":{"lat":33.20004,"lon":-117.24254}},{"facility":"Pfizer Investigational Site","city":"Walnut Creek","state":"California","zip":"94598","country":"United States","geoPoint":{"lat":37.90631,"lon":-122.06496}},{"facility":"Pfizer Investigational Site","city":"Colorado Springs","state":"Colorado","zip":"80910","country":"United States","geoPoint":{"lat":38.83388,"lon":-104.82136}},{"facility":"Pfizer Investigational Site","city":"Denver","state":"Colorado","zip":"80218","country":"United States","geoPoint":{"lat":39.73915,"lon":-104.9847}},{"facility":"Pfizer Investigational Site","city":"Englewood","state":"Colorado","zip":"80112","country":"United States","geoPoint":{"lat":39.64777,"lon":-104.98776}},{"facility":"Pfizer Investigational Site","city":"Longmont","state":"Colorado","zip":"80501","country":"United States","geoPoint":{"lat":40.16721,"lon":-105.10193}},{"facility":"Pfizer Investigational Site","city":"New London","state":"Connecticut","zip":"06320","country":"United States","geoPoint":{"lat":41.35565,"lon":-72.09952}},{"facility":"Pfizer Investigational Site","city":"Newark","state":"Delaware","zip":"19713","country":"United States","geoPoint":{"lat":39.68372,"lon":-75.74966}},{"facility":"Pfizer Investigational Site","city":"Brooksville","state":"Florida","zip":"34601","country":"United States","geoPoint":{"lat":28.55554,"lon":-82.38991}},{"facility":"Pfizer Investigational Site","city":"Clearwater","state":"Florida","zip":"33759","country":"United States","geoPoint":{"lat":27.96585,"lon":-82.8001}},{"facility":"Pfizer Investigational Site","city":"Clearwater","state":"Florida","zip":"33761","country":"United States","geoPoint":{"lat":27.96585,"lon":-82.8001}},{"facility":"Pfizer Investigational Site","city":"Daytona Beach","state":"Florida","zip":"32114","country":"United States","geoPoint":{"lat":29.21081,"lon":-81.02283}},{"facility":"Pfizer Investigational Site","city":"Fort Myers","state":"Florida","zip":"33916","country":"United States","geoPoint":{"lat":26.62168,"lon":-81.84059}},{"facility":"Pfizer Investigational Site","city":"Gainesville","state":"Florida","zip":"32610","country":"United States","geoPoint":{"lat":29.65163,"lon":-82.32483}},{"facility":"Pfizer Investigational Site","city":"Lake Worth","state":"Florida","zip":"33461","country":"United States","geoPoint":{"lat":26.61708,"lon":-80.07231}},{"facility":"Pfizer Investigational Site","city":"New Port Richey","state":"Florida","zip":"34652","country":"United States","geoPoint":{"lat":28.24418,"lon":-82.71927}},{"facility":"Pfizer Investigational Site","city":"Palm Harbor","state":"Florida","zip":"34684","country":"United States","geoPoint":{"lat":28.07807,"lon":-82.76371}},{"facility":"Pfizer Investigational Site","city":"Pembroke Pines","state":"Florida","zip":"33024","country":"United States","geoPoint":{"lat":26.00315,"lon":-80.22394}},{"facility":"Pfizer Investigational Site","city":"South Miami","state":"Florida","zip":"33143","country":"United States","geoPoint":{"lat":25.7076,"lon":-80.29338}},{"facility":"Pfizer Investigational Site","city":"Tampa","state":"Florida","zip":"33606","country":"United States","geoPoint":{"lat":27.94752,"lon":-82.45843}},{"facility":"Pfizer Investigational Site","city":"West Palm Beach","state":"Florida","zip":"33409","country":"United States","geoPoint":{"lat":26.71534,"lon":-80.05337}},{"facility":"Pfizer Investigational Site","city":"Atlanta","state":"Georgia","zip":"30342","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"Pfizer Investigational Site","city":"Decatur","state":"Georgia","zip":"30033","country":"United States","geoPoint":{"lat":33.77483,"lon":-84.29631}},{"facility":"Pfizer Investigational Site","city":"Decatur","state":"Georgia","zip":"30319","country":"United States","geoPoint":{"lat":33.77483,"lon":-84.29631}},{"facility":"Pfizer Investigational Site","city":"Savannah","state":"Georgia","zip":"31406","country":"United States","geoPoint":{"lat":32.08354,"lon":-81.09983}},{"facility":"Pfizer Investigational Site","city":"Boise","state":"Idaho","zip":"83702","country":"United States","geoPoint":{"lat":43.6135,"lon":-116.20345}},{"facility":"Pfizer Investigational Site","city":"Idaho Falls","state":"Idaho","zip":"83404","country":"United States","geoPoint":{"lat":43.46658,"lon":-112.03414}},{"facility":"Pfizer Investigational Site","city":"Indianapolis","state":"Indiana","zip":"46202","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Pfizer Investigational Site","city":"Indianapolis","state":"Indiana","zip":"46260","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Pfizer Investigational Site","city":"South Bend","state":"Indiana","zip":"46601","country":"United States","geoPoint":{"lat":41.68338,"lon":-86.25001}},{"facility":"Pfizer Investigational Site","city":"Overland Park","state":"Kansas","zip":"66210","country":"United States","geoPoint":{"lat":38.98223,"lon":-94.67079}},{"facility":"Pfizer Investigational Site","city":"Lexington","state":"Kentucky","zip":"40509","country":"United States","geoPoint":{"lat":37.98869,"lon":-84.47772}},{"facility":"Pfizer Investigational Site","city":"Louisville","state":"Kentucky","zip":"40291","country":"United States","geoPoint":{"lat":38.25424,"lon":-85.75941}},{"facility":"Pfizer Investigational Site","city":"New Orleans","state":"Louisiana","zip":"70114","country":"United States","geoPoint":{"lat":29.95465,"lon":-90.07507}},{"facility":"Pfizer Investigational Site","city":"Scarborough","state":"Maine","zip":"04074","country":"United States","geoPoint":{"lat":43.57814,"lon":-70.32172}},{"facility":"Pfizer Investigational Site","city":"Ann Arbor","state":"Michigan","zip":"48106","country":"United States","geoPoint":{"lat":42.27756,"lon":-83.74088}},{"facility":"Pfizer Investigational Site","city":"Brooklyn Center","state":"Minnesota","zip":"55430","country":"United States","geoPoint":{"lat":45.07608,"lon":-93.33273}},{"facility":"Pfizer Investigational Site","city":"Creve Coeur","state":"Missouri","zip":"63141","country":"United States","geoPoint":{"lat":38.66089,"lon":-90.42262}},{"facility":"Pfizer Investigational Site","city":"Billings","state":"Montana","zip":"59101","country":"United States","geoPoint":{"lat":45.78329,"lon":-108.50069}},{"facility":"Pfizer Investigational Site","city":"Billings","state":"Montana","zip":"59102","country":"United States","geoPoint":{"lat":45.78329,"lon":-108.50069}},{"facility":"Pfizer Investigational Site","city":"Lincoln","state":"Nebraska","zip":"68510","country":"United States","geoPoint":{"lat":40.8,"lon":-96.66696}},{"facility":"Pfizer Investigational Site","city":"Las Vegas","state":"Nevada","zip":"89109","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"Pfizer Investigational Site","city":"Las Vegas","state":"Nevada","zip":"89146","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"Pfizer Investigational Site","city":"Reno","state":"Nevada","zip":"89502","country":"United States","geoPoint":{"lat":39.52963,"lon":-119.8138}},{"facility":"Pfizer Investigational Site","city":"Lebanon","state":"New Hampshire","zip":"03756","country":"United States","geoPoint":{"lat":43.64229,"lon":-72.25176}},{"facility":"Pfizer Investigational Site","city":"New Brunswick","state":"New Jersey","zip":"08901","country":"United States","geoPoint":{"lat":40.48622,"lon":-74.45182}},{"facility":"Pfizer Investigational Site","city":"Albuquerque","state":"New Mexico","zip":"87102","country":"United States","geoPoint":{"lat":35.08449,"lon":-106.65114}},{"facility":"Pfizer Investigational Site","city":"New York","state":"New York","zip":"10032","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Pfizer Investigational Site","city":"Winston-Salem","state":"North Carolina","zip":"27103","country":"United States","geoPoint":{"lat":36.09986,"lon":-80.24422}},{"facility":"Pfizer Investigational Site","city":"Bismarck","state":"North Dakota","zip":"58501","country":"United States","geoPoint":{"lat":46.80833,"lon":-100.78374}},{"facility":"Pfizer Investigational Site","city":"Fargo","state":"North Dakota","zip":"58104","country":"United States","geoPoint":{"lat":46.87719,"lon":-96.7898}},{"facility":"Pfizer Investigational Site","city":"Jamestown","state":"North Dakota","zip":"58401","country":"United States","geoPoint":{"lat":46.91054,"lon":-98.70844}},{"facility":"Pfizer Investigational Site","city":"Akron","state":"Ohio","zip":"44311","country":"United States","geoPoint":{"lat":41.08144,"lon":-81.51901}},{"facility":"Pfizer Investigational Site","city":"Cincinnati","state":"Ohio","zip":"45267-0457","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"Pfizer Investigational Site","city":"Cleveland","state":"Ohio","zip":"44122","country":"United States","geoPoint":{"lat":41.4995,"lon":-81.69541}},{"facility":"Pfizer Investigational Site","city":"Englewood","state":"Ohio","zip":"45322","country":"United States","geoPoint":{"lat":39.87756,"lon":-84.30217}},{"facility":"Pfizer Investigational Site","city":"Oklahoma City","state":"Oklahoma","zip":"73112-4481","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"Pfizer Investigational Site","city":"Eugene","state":"Oregon","zip":"97401","country":"United States","geoPoint":{"lat":44.05207,"lon":-123.08675}},{"facility":"Pfizer Investigational Site","city":"Medford","state":"Oregon","zip":"97504","country":"United States","geoPoint":{"lat":42.32652,"lon":-122.87559}},{"facility":"Pfizer Investigational Site","city":"Erie","state":"Pennsylvania","zip":"16502","country":"United States","geoPoint":{"lat":42.12922,"lon":-80.08506}},{"facility":"Pfizer Investigational Site","city":"Erie","state":"Pennsylvania","zip":"16507-1411","country":"United States","geoPoint":{"lat":42.12922,"lon":-80.08506}},{"facility":"Pfizer Investigational Site","city":"Jenkintown","state":"Pennsylvania","zip":"19046","country":"United States","geoPoint":{"lat":40.09594,"lon":-75.12517}},{"facility":"Pfizer Investigational Site","city":"Philadelphia","state":"Pennsylvania","zip":"19114","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}},{"facility":"Pfizer Investigational Site","city":"Pittsburgh","state":"Pennsylvania","zip":"15206","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}},{"facility":"Pfizer Investigational Site","city":"Wexford","state":"Pennsylvania","zip":"15090","country":"United States","geoPoint":{"lat":40.62646,"lon":-80.05589}},{"facility":"Pfizer Investigational Site","city":"Warwick","state":"Rhode Island","zip":"02886","country":"United States","geoPoint":{"lat":41.7001,"lon":-71.41617}},{"facility":"Pfizer Investigational Site","city":"Greer","state":"South Carolina","zip":"29651","country":"United States","geoPoint":{"lat":34.93873,"lon":-82.22706}},{"facility":"Pfizer Investigational Site","city":"Hilton Head Island","state":"South Carolina","zip":"29926","country":"United States","geoPoint":{"lat":32.19382,"lon":-80.73816}},{"facility":"Pfizer Investigational Site","city":"Sioux Falls","state":"South Dakota","zip":"57104","country":"United States","geoPoint":{"lat":43.54369,"lon":-96.72796}},{"facility":"Pfizer Investigational Site","city":"Sioux Falls","state":"South Dakota","zip":"57105","country":"United States","geoPoint":{"lat":43.54369,"lon":-96.72796}},{"facility":"Pfizer Investigational Site","city":"Watertown","state":"South Dakota","zip":"57201","country":"United States","geoPoint":{"lat":44.89941,"lon":-97.11507}},{"facility":"Pfizer Investigational Site","city":"Chattanooga","state":"Tennessee","zip":"37404","country":"United States","geoPoint":{"lat":35.04563,"lon":-85.30968}},{"facility":"Pfizer Investigational Site","city":"Knoxville","state":"Tennessee","zip":"37920","country":"United States","geoPoint":{"lat":35.96064,"lon":-83.92074}},{"facility":"Pfizer Investigational Site","city":"Nashville","state":"Tennessee","zip":"37203","country":"United States","geoPoint":{"lat":36.16589,"lon":-86.78444}},{"facility":"Pfizer Investigational Site","city":"Dallas","state":"Texas","zip":"75234","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Pfizer Investigational Site","city":"Houston","state":"Texas","zip":"77030","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Pfizer Investigational Site","city":"Midland","state":"Texas","zip":"79705","country":"United States","geoPoint":{"lat":31.99735,"lon":-102.07791}},{"facility":"Pfizer Investigational Site","city":"Plano","state":"Texas","zip":"75093","country":"United States","geoPoint":{"lat":33.01984,"lon":-96.69889}},{"facility":"Pfizer Investigational Site","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Pfizer Investigational Site","city":"Waco","state":"Texas","zip":"76712","country":"United States","geoPoint":{"lat":31.54933,"lon":-97.14667}},{"facility":"Pfizer Investigational Site","city":"Salt Lake City","state":"Utah","zip":"84117","country":"United States","geoPoint":{"lat":40.76078,"lon":-111.89105}},{"facility":"Pfizer Investigational Site","city":"Sandy City","state":"Utah","zip":"84070","country":"United States","geoPoint":{"lat":40.59161,"lon":-111.8841}},{"facility":"Pfizer Investigational Site","city":"Burlington","state":"Vermont","zip":"05401","country":"United States","geoPoint":{"lat":44.47588,"lon":-73.21207}},{"facility":"Pfizer Investigational Site","city":"Norfolk","state":"Virginia","zip":"23502","country":"United States","geoPoint":{"lat":36.84681,"lon":-76.28522}},{"facility":"Pfizer Investigational Site","city":"Norfolk","state":"Virginia","zip":"23507","country":"United States","geoPoint":{"lat":36.84681,"lon":-76.28522}},{"facility":"Pfizer Investigational Site","city":"Richmond","state":"Virginia","zip":"23294","country":"United States","geoPoint":{"lat":37.55376,"lon":-77.46026}},{"facility":"Pfizer Investigational Site","city":"Seattle","state":"Washington","zip":"98105","country":"United States","geoPoint":{"lat":47.60621,"lon":-122.33207}},{"facility":"Pfizer Investigational Site","city":"Menomonee Falls","state":"Wisconsin","zip":"53051","country":"United States","geoPoint":{"lat":43.1789,"lon":-88.11731}},{"facility":"Pfizer Investigational Site","city":"Calgary","state":"Alberta","zip":"T2N 4L7","country":"Canada","geoPoint":{"lat":51.05011,"lon":-114.08529}},{"facility":"Pfizer Investigational Site","city":"Coquitlam","state":"British Columbia","zip":"V3K 3V9","country":"Canada","geoPoint":{"lat":49.2846,"lon":-122.78217}},{"facility":"Pfizer Investigational Site","city":"Surrey","state":"British Columbia","zip":"V4A 2H9","country":"Canada","geoPoint":{"lat":49.10635,"lon":-122.82509}},{"facility":"Pfizer Investigational Site","city":"Winnipeg","state":"Manitoba","zip":"R3T 2E8","country":"Canada","geoPoint":{"lat":49.8844,"lon":-97.14704}},{"facility":"Pfizer Investigational Site","city":"Antigonish Nova Scotia","state":"Nova Scotia","zip":"B2G 2C2","country":"Canada","geoPoint":{"lat":45.61685,"lon":-61.99858}},{"facility":"Pfizer Investigational Site","city":"Corunna","state":"Ontario","zip":"N0N 1G0","country":"Canada","geoPoint":{"lat":42.88338,"lon":-82.43313}},{"facility":"Pfizer Investigational Site","city":"Ottawa","state":"Ontario","zip":"K1H 7W9","country":"Canada","geoPoint":{"lat":45.41117,"lon":-75.69812}},{"facility":"Pfizer Investigational Site","city":"Sarnia","state":"Ontario","zip":"N7T 4X3","country":"Canada","geoPoint":{"lat":42.97866,"lon":-82.40407}},{"facility":"Pfizer Investigational Site","city":"Toronto","state":"Ontario","zip":"M4S 1Y2","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"Pfizer Investigational Site","city":"Toronto","state":"Ontario","zip":"M5B 1W8","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"Pfizer Investigational Site","city":"Toronto","state":"Ontario","zip":"M9W 4L6","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"Pfizer Investigational Site","city":"Gatineau","state":"Quebec","zip":"J9A 1K7","country":"Canada","geoPoint":{"lat":45.47723,"lon":-75.70164}},{"facility":"Pfizer Investigational Site","city":"L'Ancienne-Lorette","state":"Quebec","zip":"G2E 2X1","country":"Canada","geoPoint":{"lat":46.79392,"lon":-71.35191}},{"facility":"Pfizer Investigational Site","city":"Pointe-Claire","state":"Quebec","zip":"H9R 4S3","country":"Canada","geoPoint":{"lat":45.44868,"lon":-73.81669}},{"facility":"Pfizer Investigational Site","city":"Québec","state":"Quebec","zip":"G1S 2L6","country":"Canada","geoPoint":{"lat":46.81228,"lon":-71.21454}},{"facility":"Pfizer Investigational Site","city":"Saint Romuald","state":"Quebec","zip":"G6W 5M6","country":"Canada","geoPoint":{"lat":46.75818,"lon":-71.23921}},{"facility":"Pfizer Investigational Site","city":"Saint-Janvier","state":"Quebec","zip":"J7J 2K8","country":"Canada","geoPoint":{"lat":45.70504,"lon":-73.92849}},{"facility":"Pfizer Investigational Site","city":"Shawinigan","state":"Quebec","zip":"G9N 2H6","country":"Canada","geoPoint":{"lat":46.56675,"lon":-72.74913}},{"facility":"Pfizer Investigational Site","city":"Sherbrooke","state":"Quebec","zip":"J1H 4J6","country":"Canada","geoPoint":{"lat":45.40008,"lon":-71.89908}}]},"referencesModule":{"references":[{"pmid":"23266840","type":"DERIVED","citation":"Archer DF, Pinkerton JV, Guico-Pabia CJ, Hwang E, Cheng RF; Study 3353 Investigators. Cardiovascular, cerebrovascular, and hepatic safety of desvenlafaxine for 1 year in women with vasomotor symptoms associated with menopause. Menopause. 2013 Jan;20(1):47-56. doi: 10.1097/gme.0b013e3182775fe9."},{"pmid":"23266839","type":"DERIVED","citation":"Pinkerton JV, Archer DF, Guico-Pabia CJ, Hwang E, Cheng RF. Maintenance of the efficacy of desvenlafaxine in menopausal vasomotor symptoms: a 1-year randomized controlled trial. Menopause. 2013 Jan;20(1):38-46. doi: 10.1097/GME.0b013e318274699f."},{"pmid":"23010882","type":"DERIVED","citation":"Pinkerton JV, Constantine G, Hwang E, Cheng RF; Study 3353 Investigators. Desvenlafaxine compared with placebo for treatment of menopausal vasomotor symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind, placebo-controlled efficacy trial. Menopause. 2013 Jan;20(1):28-37. doi: 10.1097/gme.0b013e31826421a8."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A2-3353&StudyName=Study%20Evaluating%20The%20Safety%20And%20Efficacy%20Of%20Desvenlafaxine%20Succinate%20For%20Vasomotor%20Symptoms%20In%20Menopausal%20Women"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 3784 participants were screened, of which 1598 participants were screen failures and 2186 participants were randomly assigned to treatment.","groups":[{"id":"FG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"FG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"1101"},{"groupId":"FG001","numSubjects":"1085"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"1066"},{"groupId":"FG001","numSubjects":"1052"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"669"},{"groupId":"FG001","numSubjects":"719"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"432"},{"groupId":"FG001","numSubjects":"366"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"195"},{"groupId":"FG001","numSubjects":"102"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"57"},{"groupId":"FG001","numSubjects":"44"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"16"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"66"},{"groupId":"FG001","numSubjects":"64"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"61"},{"groupId":"FG001","numSubjects":"104"}]},{"type":"Randomized, not treated","reasons":[{"groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"33"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"BG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"1066"},{"groupId":"BG001","value":"1052"},{"groupId":"BG002","value":"2118"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"53.95","spread":"4.90"},{"groupId":"BG001","value":"53.59","spread":"4.91"},{"groupId":"BG002","value":"53.77","spread":"4.90"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1066"},{"groupId":"BG001","value":"1052"},{"groupId":"BG002","value":"2118"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Daily number of moderate and severe hot flushes","description":"Average daily number of moderate and severe hot flushes was calculated as the sum of number of moderate and severe hot flushes on each day divided by number of days with data. Moderate: sensation of heat with sweating; able to continue activity; and severe: sensation of heat with sweating; causing cessation of activity. Participants analysed were 184 and 181 for DVS SR 100 mg group and placebo group, respectively.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Hot Flushes","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"11.67","spread":"5.62"},{"groupId":"BG001","value":"11.91","spread":"5.71"},{"groupId":"BG002","value":"11.79","spread":"5.66"}]}]}]},{"title":"Daily severity score of hot flushes","description":"Severity: mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). Average daily severity of hot flushes for each time period was calculated as (1\\*Number of mild+2\\*Number of moderate+3\\*Number of severe)/(Total number of hot flushes). For days with no hot flushes, severity score was set as 0. As this was derived from count data, there was no maximum; minimum score was 0; the higher values showed worse outcomes. n=184 (DVS SR 100 mg group); n=181 (placebo group).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2.36","spread":"0.34"},{"groupId":"BG001","value":"2.39","spread":"0.35"},{"groupId":"BG002","value":"2.37","spread":"0.34"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4","description":"The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.","populationDescription":"Modified Intent-to-Treat(MITT) population: Participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks. Last observation carried forward (LOCF) method was used. 1 participant in each group did not have data till Week 4.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Hot Flushes","timeFrame":"Baseline and Week 4","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"183"},{"groupId":"OG001","value":"180"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.52","spread":"0.33"},{"groupId":"OG001","value":"-3.64","spread":"0.33"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"Adjusted Mean Difference","paramValue":"-2.89","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.80","ciUpperLimit":"-1.98"}]},{"type":"PRIMARY","title":"Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12","description":"The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.","populationDescription":"MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Hot Flushes","timeFrame":"Baseline and Week 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"181"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.31","spread":"0.35"},{"groupId":"OG001","value":"-4.52","spread":"0.35"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"Adjusted Mean Difference","paramValue":"-2.79","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.77","ciUpperLimit":"-1.82"}]},{"type":"PRIMARY","title":"Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4","description":"Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1\\*Number of mild+2\\*Number of moderate+3\\*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.","populationDescription":"MITT population: All participants randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using LOCF method. 1 participant in each group did not have data till Week 4.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a Scale","timeFrame":"Baseline and Week 4","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"183"},{"groupId":"OG001","value":"180"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.47","spread":"0.04"},{"groupId":"OG001","value":"-0.19","spread":"0.04"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"Adjusted Mean Difference","paramValue":"-0.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.40","ciUpperLimit":"-0.16"}]},{"type":"PRIMARY","title":"Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12","description":"Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1\\*Number of mild+2\\*Number of moderate+3\\*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.","populationDescription":"MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a Scale","timeFrame":"Baseline and Week 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"181"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.59","spread":"0.05"},{"groupId":"OG001","value":"-0.28","spread":"0.05"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"Adjusted Mean Difference","paramValue":"-0.31","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.44","ciUpperLimit":"-0.18"}]},{"type":"PRIMARY","title":"Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events","description":"Adjudicated ischemic cardiovascular events were a composite of: a) Coronary Heart Disease (CHD)-related death; b) New Myocardial Infarction (MI) (non-procedure-related MI); c) Documented new onset of unstable angina requiring hospitalization; d) Unscheduled coronary revascularization procedures (percutaneous coronary intervention) or bypass grafting.","populationDescription":"Safety population included all randomized participants who received at least 1 dose of study medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline up to Month 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1066"},{"groupId":"OG001","value":"1052"}]}],"classes":[{"title":"Any ischemic CV event","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"CHD related death","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"New MI","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"New Onset of Unstable Angina","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Unscheduled Coronary Revascularization Procedures","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Excess risk of DVS SR 100 mg over placebo per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Wald Formula","paramValue":"-1.07","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.86","ciUpperLimit":"0.72","estimateComment":"The 90% CI for excess risk was obtained using the Wald Formula."}]},{"type":"SECONDARY","title":"Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes","description":"A mean decrease from baseline of at least 5.35 moderate to severe hot flushes at week 12 in the participants was considered clinically meaningful.","populationDescription":"MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline and Week 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"181"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"75"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The proportion of participants achieving a response as defined by minimal clinically important difference (MCID) at week 12 was compared between DVS and placebo treatment groups with a Cochran-Mantel-Haenszel test.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes","description":"The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.","populationDescription":"MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline, Week 4 and Week 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"181"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"58.47"},{"groupId":"OG001","value":"28.89"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"67.93"},{"groupId":"OG001","value":"44.20"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The proportion of participants achieving at least 50% hot flush reduction from baseline at 4-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"3.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.24","ciUpperLimit":"5.36"},{"groupIds":["OG000","OG001"],"groupDescription":"The proportion of participants achieving at least 50% hot flush reduction from baseline at 12-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.67","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.75","ciUpperLimit":"4.10"}]},{"type":"SECONDARY","title":"Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes","description":"The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.","populationDescription":"MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline, Week 4 and Week 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"181"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"32.79"},{"groupId":"OG001","value":"10.00"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"41.30"},{"groupId":"OG001","value":"18.23"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The proportion of participants achieving at least 75% hot flush reduction from baseline at 4-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"4.39","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.47","ciUpperLimit":"7.81"},{"groupIds":["OG000","OG001"],"groupDescription":"The proportion of participants achieving at least 75% hot flush reduction from baseline at 12-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"3.16","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.96","ciUpperLimit":"5.09"}]},{"type":"SECONDARY","title":"Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes","description":"Time to response was defined as the time-to-first 50% reduction in the average daily number of moderate to severe hot flushes over 3 consecutive days.","populationDescription":"MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Days","timeFrame":"Week 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"181"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13.0","lowerLimit":"10.0","upperLimit":"18.0"},{"groupId":"OG001","value":"48.0","lowerLimit":"32.0","upperLimit":"64.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A log-rank test was used to compare the treatment groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Log Rank","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12","description":"The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. Adjusted mean was calculated by using change from baseline as response variable, treatment as factor, and baseline as covariate using the observed cases.","populationDescription":"MITT participants of the efficacy sub-study population who had non-missing average daily number of moderate and severe hot flushes. The assessment was done using observed values. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Hot Flushes","timeFrame":"Baseline, Month 6 and Month 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"181"}]}],"classes":[{"title":"Month 6 (n= 125, 124)","categories":[{"measurements":[{"groupId":"OG000","value":"-8.65","spread":"0.37"},{"groupId":"OG001","value":"-6.61","spread":"0.37"}]}]},{"title":"Month 12 (n= 112, 102)","categories":[{"measurements":[{"groupId":"OG000","value":"-7.98","spread":"0.46"},{"groupId":"OG001","value":"-5.17","spread":"0.48"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 6)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"Adjusted Mean Difference","paramValue":"-2.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.07","ciUpperLimit":"-1.00"},{"groupIds":["OG000","OG001"],"groupDescription":"An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"Adjusted Mean Difference","paramValue":"-2.81","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.12","ciUpperLimit":"-1.51"}]},{"type":"SECONDARY","title":"Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12","description":"Severity: mild (heat sensation without sweating); moderate (heat sensation with sweating; able to continue activity); severe (heat sensation with sweating; causing cessation of activity). Average daily severity of hot flushes= (1\\*Number of mild+2\\*Number of moderate+3\\*Number of severe)/(Total number of hot flushes). Days with no hot flushes: severity score=0. As it was derived from count data, there was no maximum; minimum score=0; higher values= worse outcomes. Adjusted mean: calculated using change from baseline=response variable, treatment=factor and baseline=covariate using observed cases.","populationDescription":"MITT participants of the efficacy sub-study population who had non-missing average daily number of moderate and severe hot flushes. The assessment was done using observed values. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a Scale","timeFrame":"Baseline, Month 6 and Month 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"181"}]}],"classes":[{"title":"Month 6 (n= 125, 124)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.87","spread":"0.07"},{"groupId":"OG001","value":"-0.56","spread":"0.07"}]}]},{"title":"Month 12 (n= 112, 102)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.78","spread":"0.07"},{"groupId":"OG001","value":"-0.45","spread":"0.08"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 6)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","statisticalMethod":"ANCOVA","paramType":"Adjusted Mean Difference","paramValue":"-0.31","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.51","ciUpperLimit":"-0.12"},{"groupIds":["OG000","OG001"],"groupDescription":"An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.003","statisticalMethod":"ANCOVA","paramType":"Adjusted Mean Difference","paramValue":"-0.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.54","ciUpperLimit":"-0.11"}]},{"type":"SECONDARY","title":"Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12","description":"GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms \\[range 0-33\\], anxiety \\[range 0-18\\], depression \\[range 0-15\\], somatic symptoms \\[range 0-21\\], vasomotor symptoms \\[range 0-6\\], and sexual dysfunction \\[range 0-3\\]). A decrease in the total climacteric score indicated an improvement in symptoms.","populationDescription":"Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy Greene Climacteric Scale (GCS) assessment or at least 1 on therapy Patient Global Impression (PGI) assessment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a Scale","timeFrame":"Baseline and Week 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"964"},{"groupId":"OG001","value":"986"}]}],"classes":[{"title":"Baseline: Total Score","categories":[{"measurements":[{"groupId":"OG000","value":"22.48","spread":"0.28"},{"groupId":"OG001","value":"22.04","spread":"0.28"}]}]},{"title":"Baseline: Anxiety Scale","categories":[{"measurements":[{"groupId":"OG000","value":"6.43","spread":"0.10"},{"groupId":"OG001","value":"6.36","spread":"0.10"}]}]},{"title":"Baseline: Depression Scale","categories":[{"measurements":[{"groupId":"OG000","value":"4.92","spread":"0.10"},{"groupId":"OG001","value":"4.84","spread":"0.09"}]}]},{"title":"Baseline: Sexual Dysfunction Scale","categories":[{"measurements":[{"groupId":"OG000","value":"1.60","spread":"0.03"},{"groupId":"OG001","value":"1.65","spread":"0.03"}]}]},{"title":"Baseline: Psychological Scale","categories":[{"measurements":[{"groupId":"OG000","value":"11.35","spread":"0.18"},{"groupId":"OG001","value":"11.19","spread":"0.18"}]}]},{"title":"Baseline: Somatic Scale","categories":[{"measurements":[{"groupId":"OG000","value":"4.54","spread":"0.11"},{"groupId":"OG001","value":"4.21","spread":"0.11"}]}]},{"title":"Baseline: Vasomotor Scale","categories":[{"measurements":[{"groupId":"OG000","value":"4.99","spread":"0.04"},{"groupId":"OG001","value":"4.99","spread":"0.04"}]}]},{"title":"Week 12: Total Score","categories":[{"measurements":[{"groupId":"OG000","value":"-9.18","spread":"0.25"},{"groupId":"OG001","value":"-6.84","spread":"0.25"}]}]},{"title":"Week 12: Anxiety Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-2.81","spread":"0.09"},{"groupId":"OG001","value":"-2.06","spread":"0.09"}]}]},{"title":"Week 12: Depression Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-2.23","spread":"0.08"},{"groupId":"OG001","value":"-1.55","spread":"0.08"}]}]},{"title":"Week 12: Sexual Dysfunction Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-0.41","spread":"0.03"},{"groupId":"OG001","value":"-0.36","spread":"0.03"}]}]},{"title":"Week 12: Psychological Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-5.04","spread":"0.15"},{"groupId":"OG001","value":"-3.62","spread":"0.15"}]}]},{"title":"Week 12: Somatic Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-1.24","spread":"0.09"},{"groupId":"OG001","value":"-1.02","spread":"0.09"}]}]},{"title":"Week 12: Vasomotor Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-2.50","spread":"0.05"},{"groupId":"OG001","value":"-1.85","spread":"0.05"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"For Week 12: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-2.34","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.05","ciUpperLimit":"-1.64"},{"groupIds":["OG000","OG001"],"groupDescription":"For Week 12: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-0.75","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.99","ciUpperLimit":"-0.51"},{"groupIds":["OG000","OG001"],"groupDescription":"For Week 12: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-0.67","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.89","ciUpperLimit":"-0.45"},{"groupIds":["OG000","OG001"],"groupDescription":"For Week 12: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.162","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.13","ciUpperLimit":"0.02"},{"groupIds":["OG000","OG001"],"groupDescription":"For Week 12: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 was outcome variable, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-1.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.84","ciUpperLimit":"-1.00"},{"groupIds":["OG000","OG001"],"groupDescription":"For Week 12: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.066","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.46","ciUpperLimit":"0.01"},{"groupIds":["OG000","OG001"],"groupDescription":"For Week 12: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-0.64","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.79","ciUpperLimit":"-0.50"}]},{"type":"SECONDARY","title":"Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6","description":"GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms \\[range 0-33\\], anxiety \\[range 0-18\\], depression \\[range 0-15\\], somatic symptoms \\[range 0-21\\], vasomotor symptoms \\[range 0-6\\], and sexual dysfunction \\[range 0-3\\]). A decrease in the total climacteric score indicated an improvement in symptoms.","populationDescription":"Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a Scale","timeFrame":"Baseline and Month 6","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"796"},{"groupId":"OG001","value":"836"}]}],"classes":[{"title":"Total Score","categories":[{"measurements":[{"groupId":"OG000","value":"-9.84","spread":"0.25"},{"groupId":"OG001","value":"-7.97","spread":"0.25"}]}]},{"title":"Anxiety Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-3.06","spread":"0.09"},{"groupId":"OG001","value":"-2.41","spread":"0.09"}]}]},{"title":"Depression Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-2.35","spread":"0.08"},{"groupId":"OG001","value":"-1.77","spread":"0.08"}]}]},{"title":"Sexual Dysfunction Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-0.46","spread":"0.03"},{"groupId":"OG001","value":"-0.41","spread":"0.03"}]}]},{"title":"Psychological Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-5.39","spread":"0.15"},{"groupId":"OG001","value":"-4.15","spread":"0.15"}]}]},{"title":"Somatic Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-1.49","spread":"0.08"},{"groupId":"OG001","value":"-1.31","spread":"0.08"}]}]},{"title":"Vasomotor Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-2.55","spread":"0.06"},{"groupId":"OG001","value":"-2.14","spread":"0.05"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"For Month 6: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-1.87","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.57","ciUpperLimit":"-1.18"},{"groupIds":["OG000","OG001"],"groupDescription":"For Month 6: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-0.65","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.90","ciUpperLimit":"-0.41"},{"groupIds":["OG000","OG001"],"groupDescription":"For Month 6: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-0.58","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.80","ciUpperLimit":"-0.37"},{"groupIds":["OG000","OG001"],"groupDescription":"For Month 6: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.282","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.13","ciUpperLimit":"0.04"},{"groupIds":["OG000","OG001"],"groupDescription":"For Month 6: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-1.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.66","ciUpperLimit":"-0.82"},{"groupIds":["OG000","OG001"],"groupDescription":"For Month 6: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.140","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-0.17","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.41","ciUpperLimit":"0.06"},{"groupIds":["OG000","OG001"],"groupDescription":"For Month 6: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-0.41","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.56","ciUpperLimit":"-0.26"}]},{"type":"SECONDARY","title":"Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12","description":"GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms \\[range 0-33\\], anxiety \\[range 0-18\\], depression \\[range 0-15\\], somatic symptoms \\[range 0-21\\], vasomotor symptoms \\[range 0-6\\], and sexual dysfunction \\[range 0-3\\]). A decrease in the total climacteric score indicated an improvement in symptoms.","populationDescription":"Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a Scale","timeFrame":"Baseline and Month 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"673"},{"groupId":"OG001","value":"718"}]}],"classes":[{"title":"Total Score","categories":[{"measurements":[{"groupId":"OG000","value":"-10.60","spread":"0.26"},{"groupId":"OG001","value":"-8.89","spread":"0.25"}]}]},{"title":"Anxiety Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-3.25","spread":"0.09"},{"groupId":"OG001","value":"-2.69","spread":"0.09"}]}]},{"title":"Depression Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-2.66","spread":"0.08"},{"groupId":"OG001","value":"-2.04","spread":"0.08"}]}]},{"title":"Sexual Dysfunction Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-0.51","spread":"0.03"},{"groupId":"OG001","value":"-0.43","spread":"0.03"}]}]},{"title":"Psychological Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-5.88","spread":"0.16"},{"groupId":"OG001","value":"-4.70","spread":"0.15"}]}]},{"title":"Somatic Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-1.63","spread":"0.09"},{"groupId":"OG001","value":"-1.61","spread":"0.08"}]}]},{"title":"Vasomotor Scale","categories":[{"measurements":[{"groupId":"OG000","value":"-2.64","spread":"0.06"},{"groupId":"OG001","value":"-2.19","spread":"0.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"For Month 12: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-1.71","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.42","ciUpperLimit":"-1.00"},{"groupIds":["OG000","OG001"],"groupDescription":"For Month 12: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-0.56","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.81","ciUpperLimit":"-0.30"},{"groupIds":["OG000","OG001"],"groupDescription":"For Month 12: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-0.62","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.83","ciUpperLimit":"-0.40"},{"groupIds":["OG000","OG001"],"groupDescription":"For Month 12: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.082","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.17","ciUpperLimit":"0.01"},{"groupIds":["OG000","OG001"],"groupDescription":"For Month 12: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-1.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.61","ciUpperLimit":"-0.75"},{"groupIds":["OG000","OG001"],"groupDescription":"For Month 12: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.865","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.25","ciUpperLimit":"0.21"},{"groupIds":["OG000","OG001"],"groupDescription":"For Month 12: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"-0.45","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.61","ciUpperLimit":"-0.29"}]},{"type":"SECONDARY","title":"Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12","description":"PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).","populationDescription":"Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"961"},{"groupId":"OG001","value":"982"}]}],"classes":[{"title":"1= None","categories":[{"measurements":[{"groupId":"OG000","value":"8.8"},{"groupId":"OG001","value":"5.0"}]}]},{"title":"2= Minimal","categories":[{"measurements":[{"groupId":"OG000","value":"27.8"},{"groupId":"OG001","value":"18.5"}]}]},{"title":"3= Mild","categories":[{"measurements":[{"groupId":"OG000","value":"28.9"},{"groupId":"OG001","value":"26.5"}]}]},{"title":"4= Moderate","categories":[{"measurements":[{"groupId":"OG000","value":"24.9"},{"groupId":"OG001","value":"33.8"}]}]},{"title":"5= Severe","categories":[{"measurements":[{"groupId":"OG000","value":"9.6"},{"groupId":"OG001","value":"16.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6","description":"PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).","populationDescription":"Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Month 6","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"963"},{"groupId":"OG001","value":"986"}]}],"classes":[{"title":"1= None","categories":[{"measurements":[{"groupId":"OG000","value":"8.5"},{"groupId":"OG001","value":"5.7"}]}]},{"title":"2= Minimal","categories":[{"measurements":[{"groupId":"OG000","value":"32.2"},{"groupId":"OG001","value":"25.5"}]}]},{"title":"3= Mild","categories":[{"measurements":[{"groupId":"OG000","value":"27.3"},{"groupId":"OG001","value":"23.1"}]}]},{"title":"4= Moderate","categories":[{"measurements":[{"groupId":"OG000","value":"22.9"},{"groupId":"OG001","value":"31.1"}]}]},{"title":"5= Severe","categories":[{"measurements":[{"groupId":"OG000","value":"9.0"},{"groupId":"OG001","value":"14.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12","description":"PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).","populationDescription":"Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Month 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"963"},{"groupId":"OG001","value":"986"}]}],"classes":[{"title":"1= None","categories":[{"measurements":[{"groupId":"OG000","value":"10.1"},{"groupId":"OG001","value":"7.1"}]}]},{"title":"2= Minimal","categories":[{"measurements":[{"groupId":"OG000","value":"32.2"},{"groupId":"OG001","value":"27.8"}]}]},{"title":"3= Mild","categories":[{"measurements":[{"groupId":"OG000","value":"25.9"},{"groupId":"OG001","value":"21.0"}]}]},{"title":"4= Moderate","categories":[{"measurements":[{"groupId":"OG000","value":"21.6"},{"groupId":"OG001","value":"29.7"}]}]},{"title":"5= Severe","categories":[{"measurements":[{"groupId":"OG000","value":"10.3"},{"groupId":"OG001","value":"14.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12","description":"PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).","populationDescription":"MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"172"},{"groupId":"OG001","value":"175"}]}],"classes":[{"title":"1= None","categories":[{"measurements":[{"groupId":"OG000","value":"8.1"},{"groupId":"OG001","value":"1.7"}]}]},{"title":"2= Minimal","categories":[{"measurements":[{"groupId":"OG000","value":"20.3"},{"groupId":"OG001","value":"10.9"}]}]},{"title":"3= Mild","categories":[{"measurements":[{"groupId":"OG000","value":"29.1"},{"groupId":"OG001","value":"16.6"}]}]},{"title":"4= Moderate","categories":[{"measurements":[{"groupId":"OG000","value":"24.4"},{"groupId":"OG001","value":"42.9"}]}]},{"title":"5= Severe","categories":[{"measurements":[{"groupId":"OG000","value":"18.0"},{"groupId":"OG001","value":"28.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6","description":"PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).","populationDescription":"MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Month 6","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"172"},{"groupId":"OG001","value":"175"}]}],"classes":[{"title":"1= None","categories":[{"measurements":[{"groupId":"OG000","value":"12.2"},{"groupId":"OG001","value":"2.9"}]}]},{"title":"2= Minimal","categories":[{"measurements":[{"groupId":"OG000","value":"29.7"},{"groupId":"OG001","value":"18.3"}]}]},{"title":"3= Mild","categories":[{"measurements":[{"groupId":"OG000","value":"27.3"},{"groupId":"OG001","value":"17.7"}]}]},{"title":"4= Moderate","categories":[{"measurements":[{"groupId":"OG000","value":"16.9"},{"groupId":"OG001","value":"34.3"}]}]},{"title":"5= Severe","categories":[{"measurements":[{"groupId":"OG000","value":"14.0"},{"groupId":"OG001","value":"26.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12","description":"PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).","populationDescription":"MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Month 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"172"},{"groupId":"OG001","value":"175"}]}],"classes":[{"title":"1= None","categories":[{"measurements":[{"groupId":"OG000","value":"9.3"},{"groupId":"OG001","value":"4.0"}]}]},{"title":"2= Minimal","categories":[{"measurements":[{"groupId":"OG000","value":"28.5"},{"groupId":"OG001","value":"17.1"}]}]},{"title":"3= Mild","categories":[{"measurements":[{"groupId":"OG000","value":"26.7"},{"groupId":"OG001","value":"12.6"}]}]},{"title":"4= Moderate","categories":[{"measurements":[{"groupId":"OG000","value":"18.0"},{"groupId":"OG001","value":"39.4"}]}]},{"title":"5= Severe","categories":[{"measurements":[{"groupId":"OG000","value":"17.4"},{"groupId":"OG001","value":"26.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12","description":"PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).","populationDescription":"Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"962"},{"groupId":"OG001","value":"983"}]}],"classes":[{"title":"1= Very Much Improved","categories":[{"measurements":[{"groupId":"OG000","value":"25.8"},{"groupId":"OG001","value":"13.1"}]}]},{"title":"2= Much Improved","categories":[{"measurements":[{"groupId":"OG000","value":"32.3"},{"groupId":"OG001","value":"25.5"}]}]},{"title":"3= Minimally Improved","categories":[{"measurements":[{"groupId":"OG000","value":"23.3"},{"groupId":"OG001","value":"25.1"}]}]},{"title":"4= No Change","categories":[{"measurements":[{"groupId":"OG000","value":"11.5"},{"groupId":"OG001","value":"29.3"}]}]},{"title":"5= Minimally Worse","categories":[{"measurements":[{"groupId":"OG000","value":"4.1"},{"groupId":"OG001","value":"4.5"}]}]},{"title":"6= Much Worse","categories":[{"measurements":[{"groupId":"OG000","value":"2.2"},{"groupId":"OG001","value":"1.7"}]}]},{"title":"7= Very Much Worse","categories":[{"measurements":[{"groupId":"OG000","value":"0.8"},{"groupId":"OG001","value":"0.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6","description":"PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).","populationDescription":"Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Month 6","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"963"},{"groupId":"OG001","value":"986"}]}],"classes":[{"title":"1= Very Much Improved","categories":[{"measurements":[{"groupId":"OG000","value":"28.9"},{"groupId":"OG001","value":"17.1"}]}]},{"title":"2= Much Improved","categories":[{"measurements":[{"groupId":"OG000","value":"32.3"},{"groupId":"OG001","value":"27.7"}]}]},{"title":"3= Minimally Improved","categories":[{"measurements":[{"groupId":"OG000","value":"20.5"},{"groupId":"OG001","value":"20.6"}]}]},{"title":"4= No Change","categories":[{"measurements":[{"groupId":"OG000","value":"11.6"},{"groupId":"OG001","value":"26.2"}]}]},{"title":"5= Minimally Worse","categories":[{"measurements":[{"groupId":"OG000","value":"3.5"},{"groupId":"OG001","value":"5.2"}]}]},{"title":"6= Much Worse","categories":[{"measurements":[{"groupId":"OG000","value":"2.1"},{"groupId":"OG001","value":"2.6"}]}]},{"title":"7= Very Much Worse","categories":[{"measurements":[{"groupId":"OG000","value":"1.1"},{"groupId":"OG001","value":"0.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12","description":"PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).","populationDescription":"Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Month 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"963"},{"groupId":"OG001","value":"986"}]}],"classes":[{"title":"1= Very Much Improved","categories":[{"measurements":[{"groupId":"OG000","value":"31.0"},{"groupId":"OG001","value":"19.9"}]}]},{"title":"2= Much Improved","categories":[{"measurements":[{"groupId":"OG000","value":"29.2"},{"groupId":"OG001","value":"24.5"}]}]},{"title":"3= Minimally Improved","categories":[{"measurements":[{"groupId":"OG000","value":"21.1"},{"groupId":"OG001","value":"21.5"}]}]},{"title":"4= No Change","categories":[{"measurements":[{"groupId":"OG000","value":"12.7"},{"groupId":"OG001","value":"26.8"}]}]},{"title":"5= Minimally Worse","categories":[{"measurements":[{"groupId":"OG000","value":"2.4"},{"groupId":"OG001","value":"4.4"}]}]},{"title":"6= Much Worse","categories":[{"measurements":[{"groupId":"OG000","value":"2.7"},{"groupId":"OG001","value":"2.0"}]}]},{"title":"7= Very Much Worse","categories":[{"measurements":[{"groupId":"OG000","value":"0.9"},{"groupId":"OG001","value":"0.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12","description":"PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).","populationDescription":"MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"172"},{"groupId":"OG001","value":"175"}]}],"classes":[{"title":"1= Very Much Improved","categories":[{"measurements":[{"groupId":"OG000","value":"26.7"},{"groupId":"OG001","value":"7.4"}]}]},{"title":"2= Much Improved","categories":[{"measurements":[{"groupId":"OG000","value":"35.5"},{"groupId":"OG001","value":"22.3"}]}]},{"title":"3= Minimally Improved","categories":[{"measurements":[{"groupId":"OG000","value":"17.4"},{"groupId":"OG001","value":"29.7"}]}]},{"title":"4= No Change","categories":[{"measurements":[{"groupId":"OG000","value":"12.8"},{"groupId":"OG001","value":"34.3"}]}]},{"title":"5= Minimally Worse","categories":[{"measurements":[{"groupId":"OG000","value":"2.9"},{"groupId":"OG001","value":"4.6"}]}]},{"title":"6= Much Worse","categories":[{"measurements":[{"groupId":"OG000","value":"3.5"},{"groupId":"OG001","value":"1.7"}]}]},{"title":"7= Very Much Worse","categories":[{"measurements":[{"groupId":"OG000","value":"1.2"},{"groupId":"OG001","value":"0.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6","description":"PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).","populationDescription":"MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Month 6","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"172"},{"groupId":"OG001","value":"175"}]}],"classes":[{"title":"1= Very Much Improved","categories":[{"measurements":[{"groupId":"OG000","value":"34.9"},{"groupId":"OG001","value":"14.9"}]}]},{"title":"2= Much Improved","categories":[{"measurements":[{"groupId":"OG000","value":"32.6"},{"groupId":"OG001","value":"25.7"}]}]},{"title":"3= Minimally Improved","categories":[{"measurements":[{"groupId":"OG000","value":"15.7"},{"groupId":"OG001","value":"23.4"}]}]},{"title":"4= No Change","categories":[{"measurements":[{"groupId":"OG000","value":"11.0"},{"groupId":"OG001","value":"29.7"}]}]},{"title":"5= Minimally Worse","categories":[{"measurements":[{"groupId":"OG000","value":"2.3"},{"groupId":"OG001","value":"4.0"}]}]},{"title":"6= Much Worse","categories":[{"measurements":[{"groupId":"OG000","value":"2.9"},{"groupId":"OG001","value":"2.3"}]}]},{"title":"7= Very Much Worse","categories":[{"measurements":[{"groupId":"OG000","value":"0.6"},{"groupId":"OG001","value":"0.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12","description":"PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).","populationDescription":"MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Month 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"172"},{"groupId":"OG001","value":"175"}]}],"classes":[{"title":"1= Very Much Improved","categories":[{"measurements":[{"groupId":"OG000","value":"37.2"},{"groupId":"OG001","value":"13.7"}]}]},{"title":"2= Much Improved","categories":[{"measurements":[{"groupId":"OG000","value":"24.4"},{"groupId":"OG001","value":"18.3"}]}]},{"title":"3= Minimally Improved","categories":[{"measurements":[{"groupId":"OG000","value":"21.5"},{"groupId":"OG001","value":"25.1"}]}]},{"title":"4= No Change","categories":[{"measurements":[{"groupId":"OG000","value":"10.5"},{"groupId":"OG001","value":"36.0"}]}]},{"title":"5= Minimally Worse","categories":[{"measurements":[{"groupId":"OG000","value":"1.2"},{"groupId":"OG001","value":"5.1"}]}]},{"title":"6= Much Worse","categories":[{"measurements":[{"groupId":"OG000","value":"4.1"},{"groupId":"OG001","value":"1.7"}]}]},{"title":"7= Very Much Worse","categories":[{"measurements":[{"groupId":"OG000","value":"1.2"},{"groupId":"OG001","value":"0.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Participants With Adjudicated Cerebrovascular Events - Any Stroke","description":"Adjudicated cerebrovascular events were identified using Standardized MedDRA Query (SMQ), for \"central nervous system haemorrhages and cerebrovascular conditions\". Primary assessments included: 1) definite stroke, 2) probable stroke, 3) probable transient ischemic attack (TIA), and 4) no stroke or TIA.","populationDescription":"Safety population included all randomized participants who received at least 1 dose of study medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline up to Month 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1066"},{"groupId":"OG001","value":"1052"}]}],"classes":[{"title":"Any Stroke (Definite or Probable)","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"Definite Stroke","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Probable Stroke","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Wald Formula","paramValue":"1.11","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.68","ciUpperLimit":"2.9","estimateComment":"The 90% CI for excess risk is obtained using the Wald Formula."}]},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Participants With Adjudicated Cerebrovascular Events - Probable TIA","description":"Adjudicated cerebrovascular events were identified using Standardized MedDRA Query (SMQ), for \"central nervous system haemorrhages and cerebrovascular conditions\". Primary assessments included: 1) definite stroke, 2) probable stroke, 3) probable transient ischemic attack (TIA), and 4) no stroke or TIA.","populationDescription":"Safety population included all randomized participants who received at least 1 dose of study medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline up to Month 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1066"},{"groupId":"OG001","value":"1052"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Participants With Ischemic Heart Disease","description":"Potential ischaemic cardiac events were identified using the Standardized MedDRA Query (SMQ) \"Ischemic Heart Disease\".","populationDescription":"Safety population included all randomized participants who received at least 1 dose of study medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline up to Month 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1066"},{"groupId":"OG001","value":"1052"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Wald Formula","paramValue":"2.31","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.08","ciUpperLimit":"6.71","estimateComment":"The 90% CI for excess risk is obtained using the Wald Formula."}]},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Participants With Hepatic Events","description":"Hepatic events were defined as incidence of increased Liver Function Test (AST \\[aspartate aminotransferase\\] or ALT \\[alanine aminotransferase\\]) levels greater than 5 times the ULN (upper limit of normal).","populationDescription":"Safety population included all randomized participants who received at least 1 dose of study medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline up to Month 12","groups":[{"id":"OG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal."},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1066"},{"groupId":"OG001","value":"1052"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Wald Formula","paramValue":"0.08","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.51","ciUpperLimit":"3.67","estimateComment":"The 90% CI for excess risk is obtained using the Wald Formula."}]}]},"adverseEventsModule":{"frequencyThreshold":"0","description":"The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.","eventGroups":[{"id":"EG000","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.","seriousNumAffected":43,"seriousNumAtRisk":1066,"otherNumAffected":941,"otherNumAtRisk":1066},{"id":"EG001","title":"Placebo","description":"Matching placebo tablets daily until Day 365 or early withdrawal.","seriousNumAffected":36,"seriousNumAtRisk":1052,"otherNumAffected":872,"otherNumAtRisk":1052}],"seriousEvents":[{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Angina pectoris","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Coronary artery occlusion","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Palpitations","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Cerebrovascular arteriovenous malformation","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Glaucoma","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Narrow anterior chamber angle","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Retinal haemorrhage","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Colitis ischaemic","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Diverticular perforation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Gastrooesophageal reflux disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Ileus","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Ileus paralytic","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Lower gastrointestinal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Stomatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Swollen tongue","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Upper gastrointestinal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Drug therapeutic incompatibility","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Non-cardiac chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Biliary dyskinesia","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Cholecystitis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Diverticulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Enterocolitis viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Escherichia sepsis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Herpes zoster","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Laryngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Pyelonephritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Subcutaneous abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Drug toxicity","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Hand fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Intentional overdose","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Limb injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Patella fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Radius fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Traumatic intracranial haemorrhage","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Ulna fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Blood creatine phosphokinase MB increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Blood pressure increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Cardiac stress test abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Electrocardiogram T wave abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Electrocardiogram T wave inversion","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Electrocardiogram abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Hypokalaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Bunion","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Flank pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Foot deformity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Intervertebral disc protrusion","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Knee deformity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Musculoskeletal chest pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pain in extremity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Basal cell carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Breast cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Carcinoid tumour pulmonary","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Dermatofibrosarcoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Lung adenocarcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Malignant melanoma in situ","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Multiple myeloma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Non-small cell lung cancer stage III","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Ovarian cancer recurrent","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pancreatic carcinoma metastatic","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Squamous cell carcinoma of skin","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Thyroid cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Transitional cell carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Uterine leiomyoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Ageusia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Carotid artery occlusion","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Cerebral haematoma","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Cervical myelopathy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Convulsion","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Dysarthria","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Hypoaesthesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Migraine","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Paraesthesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Presyncope","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Transient ischaemic attack","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Major depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Mental status changes","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Nephrolithiasis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Renal failure acute","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Endometrial hyperplasia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Acute respiratory failure","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Asthma","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Chronic obstructive pulmonary disease","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Non-cardiogenic pulmonary oedema","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pulmonary embolism","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Erythema","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pruritus","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Rash","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]}],"otherEvents":[{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Leukopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Lymph node pain","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Lymphadenitis","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Lymphadenopathy","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":7,"numAtRisk":1052}]},{"term":"Neutropenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Pancytopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pernicious anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Splenic granuloma","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Thrombocytopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Aortic valve incompetence","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Arrhythmia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Atrioventricular block first degree","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Bundle branch block left","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Cardiac flutter","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Conduction disorder","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Palpitations","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":1066},{"groupId":"EG001","numAffected":33,"numAtRisk":1052}]},{"term":"Pulmonary valve incompetence","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Right atrial dilatation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Sinus tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Supraventricular extrasystoles","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":1066},{"groupId":"EG001","numAffected":7,"numAtRisk":1052}]},{"term":"Ventricular extrasystoles","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Keratosis follicular","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Mixed hyperlipidaemia","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Cerumen impaction","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Conductive deafness","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Deafness","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Ear canal stenosis","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Ear congestion","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Ear discomfort","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Ear disorder","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Ear haemorrhage","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Ear pain","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":1066},{"groupId":"EG001","numAffected":8,"numAtRisk":1052}]},{"term":"Ear pruritus","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Eustachian tube dysfunction","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Meniere's disease","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Middle ear effusion","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Motion sickness","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Otosclerosis","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Tinnitus","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Tympanic membrane disorder","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":1066},{"groupId":"EG001","numAffected":8,"numAtRisk":1052}]},{"term":"Vertigo positional","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Goitre","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Hyperthyroidism","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Hypothyroidism","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":11,"numAtRisk":1052}]},{"term":"Altered visual depth perception","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Angle closure glaucoma","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Asthenopia","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Astigmatism","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Blepharitis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Blepharospasm","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Cataract","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Conjunctival haemorrhage","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Conjunctivitis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Dry eye","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Episcleritis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Eye irritation","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Eye pain","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Eye pruritus","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":8,"numAtRisk":1052}]},{"term":"Eye swelling","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Eyelid cyst","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Eyelid oedema","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Eyelid ptosis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Glaucoma","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Iritis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Keratoconjunctivitis sicca","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Lacrimation increased","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Macular degeneration","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Macular oedema","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Mydriasis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Myopia","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Narrow anterior chamber angle","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Night blindness","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Ocular hyperaemia","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Photophobia","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Photopsia","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pinguecula","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Presbyopia","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pupil fixed","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Retinal aneurysm","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Retinopathy hypertensive","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Scleral hyperaemia","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Ulcerative keratitis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Vision blurred","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":1066},{"groupId":"EG001","numAffected":10,"numAtRisk":1052}]},{"term":"Visual acuity reduced","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Visual impairment","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Vitreous degeneration","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Vitreous detachment","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Vitreous floaters","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Abdominal discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":1066},{"groupId":"EG001","numAffected":20,"numAtRisk":1052}]},{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":1066},{"groupId":"EG001","numAffected":8,"numAtRisk":1052}]},{"term":"Abdominal mass","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":1066},{"groupId":"EG001","numAffected":24,"numAtRisk":1052}]},{"term":"Abdominal pain lower","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":7,"numAtRisk":1052}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":1066},{"groupId":"EG001","numAffected":41,"numAtRisk":1052}]},{"term":"Abdominal tenderness","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Abnormal faeces","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Anal fissure","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Aphthous stomatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Bowel movement irregularity","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Change of bowel habit","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Cheilitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Coeliac disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Colitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Colitis microscopic","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Colonic polyp","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":118,"numAtRisk":1066},{"groupId":"EG001","numAffected":40,"numAtRisk":1052}]},{"term":"Crohn's disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Dental caries","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":79,"numAtRisk":1066},{"groupId":"EG001","numAffected":56,"numAtRisk":1052}]},{"term":"Diarrhoea haemorrhagic","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Diverticulum","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":88,"numAtRisk":1066},{"groupId":"EG001","numAffected":15,"numAtRisk":1052}]},{"term":"Duodenal ulcer","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":1066},{"groupId":"EG001","numAffected":50,"numAtRisk":1052}]},{"term":"Dysphagia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Enterocolitis haemorrhagic","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Eructation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Faeces discoloured","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Faeces hard","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Flatulence","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Food poisoning","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Frequent bowel movements","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Gastritis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Gastrointestinal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Gastrointestinal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Gastrooesophageal reflux disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":1066},{"groupId":"EG001","numAffected":18,"numAtRisk":1052}]},{"term":"Gingival erosion","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Gingival pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Gingival swelling","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Gingival ulceration","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Glossodynia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Haematochezia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Haemorrhoidal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Haemorrhoids","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":8,"numAtRisk":1052}]},{"term":"Hiatus hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Hyperchlorhydria","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Hypoaesthesia oral","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Infrequent bowel movements","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Irritable bowel syndrome","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Lip blister","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Lip swelling","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Lower gastrointestinal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Mouth ulceration","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":279,"numAtRisk":1066},{"groupId":"EG001","numAffected":89,"numAtRisk":1052}]},{"term":"Odynophagia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Oesophageal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Oesophageal ulcer","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Oesophagitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Oral disorder","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Oral pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Oral pruritus","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Paraesthesia oral","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Peptic ulcer","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Periodontal disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Periodontitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Polyp colorectal","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Proctalgia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Proctitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Rectal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Retching","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Salivary gland enlargement","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Salivary gland pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Salivary hypersecretion","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Sensitivity of teeth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Stomatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Swollen tongue","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Tongue dry","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Tooth discolouration","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Tooth impacted","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Tooth loss","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Toothache","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":1066},{"groupId":"EG001","numAffected":30,"numAtRisk":1052}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":1066},{"groupId":"EG001","numAffected":26,"numAtRisk":1052}]},{"term":"Asthenia","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":1066},{"groupId":"EG001","numAffected":11,"numAtRisk":1052}]},{"term":"Axillary pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Chest discomfort","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":1066},{"groupId":"EG001","numAffected":11,"numAtRisk":1052}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":6,"numAtRisk":1052}]},{"term":"Chills","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":1066},{"groupId":"EG001","numAffected":8,"numAtRisk":1052}]},{"term":"Cyst","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Device breakage","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Device malfunction","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Drug intolerance","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Drug withdrawal syndrome","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Energy increased","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Facial pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":109,"numAtRisk":1066},{"groupId":"EG001","numAffected":35,"numAtRisk":1052}]},{"term":"Feeling abnormal","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Feeling cold","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Feeling drunk","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Feeling hot","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Feeling jittery","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Feeling of body temperature change","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Generalised oedema","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Hangover","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Hunger","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Impaired healing","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Implant site reaction","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Inflammation","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Influenza like illness","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":1066},{"groupId":"EG001","numAffected":14,"numAtRisk":1052}]},{"term":"Injection site haematoma","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Injection site pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Irritability","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":1066},{"groupId":"EG001","numAffected":19,"numAtRisk":1052}]},{"term":"Local swelling","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Malaise","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Mass","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Medical device pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Nodule","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Non-cardiac chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":1066},{"groupId":"EG001","numAffected":9,"numAtRisk":1052}]},{"term":"Oedema","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Oedema peripheral","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":1066},{"groupId":"EG001","numAffected":14,"numAtRisk":1052}]},{"term":"Pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":1066},{"groupId":"EG001","numAffected":40,"numAtRisk":1052}]},{"term":"Pyrexia","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":1066},{"groupId":"EG001","numAffected":21,"numAtRisk":1052}]},{"term":"Rebound effect","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Sluggishness","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Temperature intolerance","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Therapeutic response unexpected","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Thirst","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Ulcer","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Unevaluable event","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Vaccination site induration","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Vessel puncture site haematoma","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Vessel puncture site pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Vestibulitis","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Cholecystitis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Gallbladder pain","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Hepatic cirrhosis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Hepatic cyst","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Allergy to animal","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Allergy to arthropod sting","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Allergy to chemicals","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Allergy to plants","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Allergy to vaccine","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Contrast media allergy","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Drug hypersensitivity","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Food allergy","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"House dust allergy","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Hypersensitivity","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Sarcoidosis","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Seasonal allergy","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":1066},{"groupId":"EG001","numAffected":22,"numAtRisk":1052}]},{"term":"Abdominal abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Abscess intestinal","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Abscess limb","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Acute sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Anal abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Anal fungal infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Asymptomatic bacteriuria","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Bacterial infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Breast abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Breast cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Breast infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Bronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":1066},{"groupId":"EG001","numAffected":35,"numAtRisk":1052}]},{"term":"Bronchitis viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Bronchopneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Cervicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Conjunctivitis bacterial","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Conjunctivitis infective","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Cystitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":1066},{"groupId":"EG001","numAffected":15,"numAtRisk":1052}]},{"term":"Diverticulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":6,"numAtRisk":1052}]},{"term":"Ear infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":1066},{"groupId":"EG001","numAffected":17,"numAtRisk":1052}]},{"term":"Ear infection viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Eye abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Eye infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Eye infection viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Folliculitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Fungal infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":7,"numAtRisk":1052}]},{"term":"Fungal skin infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Furuncle","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":1066},{"groupId":"EG001","numAffected":6,"numAtRisk":1052}]},{"term":"Gastroenteritis viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":1066},{"groupId":"EG001","numAffected":15,"numAtRisk":1052}]},{"term":"Gastrointestinal infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Gastrointestinal viral infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Genital herpes","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Gingival infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"H1N1 influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Helicobacter infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Herpes ophthalmic","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Herpes simplex","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Herpes zoster","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":9,"numAtRisk":1052}]},{"term":"Hordeolum","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Incision site infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Infected bites","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Infected cyst","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Infected sebaceous cyst","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Infectious mononucleosis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":60,"numAtRisk":1066},{"groupId":"EG001","numAffected":61,"numAtRisk":1052}]},{"term":"Keratitis herpetic","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Kidney infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Labyrinthitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Laryngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Localised infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Lower respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":7,"numAtRisk":1052}]},{"term":"Lung infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Lymph gland infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":162,"numAtRisk":1066},{"groupId":"EG001","numAffected":168,"numAtRisk":1052}]},{"term":"Neurosyphilis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Onychomycosis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Oral candidiasis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Oral herpes","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":1066},{"groupId":"EG001","numAffected":11,"numAtRisk":1052}]},{"term":"Oral infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Osteomyelitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Otitis externa","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Otitis media","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Paronychia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Parotitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Pharyngitis streptococcal","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":6,"numAtRisk":1052}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":1066},{"groupId":"EG001","numAffected":9,"numAtRisk":1052}]},{"term":"Pneumonia primary atypical","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Respiratory tract infection viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Rhinitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":8,"numAtRisk":1052}]},{"term":"Secondary syphilis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":84,"numAtRisk":1066},{"groupId":"EG001","numAffected":69,"numAtRisk":1052}]},{"term":"Sinusitis bacterial","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Skin bacterial infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Skin infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Staphylococcal infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Staphylococcal skin infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Subcutaneous abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Tinea infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Tinea pedis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Tonsillitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Tooth abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":1066},{"groupId":"EG001","numAffected":12,"numAtRisk":1052}]},{"term":"Tooth infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":1066},{"groupId":"EG001","numAffected":9,"numAtRisk":1052}]},{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":85,"numAtRisk":1066},{"groupId":"EG001","numAffected":91,"numAtRisk":1052}]},{"term":"Urethritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":1066},{"groupId":"EG001","numAffected":61,"numAtRisk":1052}]},{"term":"Vaginal abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Vaginal infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Vaginitis bacterial","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":10,"numAtRisk":1052}]},{"term":"Viral infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":6,"numAtRisk":1052}]},{"term":"Viral labyrinthitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Viral pharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Viral upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":1066},{"groupId":"EG001","numAffected":7,"numAtRisk":1052}]},{"term":"Vulval cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Vulvovaginal candidiasis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Vulvovaginal mycotic infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":13,"numAtRisk":1052}]},{"term":"Vulvovaginitis trichomonal","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Accidental overdose","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":8,"numAtRisk":1052}]},{"term":"Animal bite","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Animal scratch","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Ankle fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Arthropod bite","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":1066},{"groupId":"EG001","numAffected":8,"numAtRisk":1052}]},{"term":"Arthropod sting","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":6,"numAtRisk":1052}]},{"term":"Avulsion fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Back injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Burns third degree","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Clavicle fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Concussion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Contusion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":1066},{"groupId":"EG001","numAffected":8,"numAtRisk":1052}]},{"term":"Corneal abrasion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Epicondylitis","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Excoriation","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Facial bones fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Fall","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Foot fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":11,"numAtRisk":1052}]},{"term":"Foreign body","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Fracture displacement","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Hand fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Head injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Incisional hernia","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Incorrect dose administered","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Joint dislocation","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Joint injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Joint sprain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":1066},{"groupId":"EG001","numAffected":16,"numAtRisk":1052}]},{"term":"Ligament rupture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Ligament sprain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Limb injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Medication error","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":57,"numAtRisk":1066},{"groupId":"EG001","numAffected":49,"numAtRisk":1052}]},{"term":"Meniscus lesion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Muscle injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Muscle rupture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Muscle strain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":1066},{"groupId":"EG001","numAffected":24,"numAtRisk":1052}]},{"term":"Patella fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Post procedural complication","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Post procedural haematoma","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Post procedural haemorrhage","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Post-traumatic pain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Procedural dizziness","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Procedural nausea","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Procedural pain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":1066},{"groupId":"EG001","numAffected":21,"numAtRisk":1052}]},{"term":"Radius fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Renal injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Rib fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Road traffic accident","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":9,"numAtRisk":1052}]},{"term":"Sciatic nerve injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Scratch","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Skeletal injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Skin laceration","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":9,"numAtRisk":1052}]},{"term":"Splinter","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Sternal fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Stress fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Sunburn","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Superficial injury of eye","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Thermal burn","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Tooth fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Traumatic haematoma","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Upper limb fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Vascular injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Venomous bite","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Vulva injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Whiplash injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Wound","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Wrist fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Alanine aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Albumin urine present","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Antinuclear antibody positive","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Arthroscopy","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Aspartate aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Autoantibody positive","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Biopsy breast","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Blood alkaline phosphatase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Blood bilirubin increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Blood cholesterol increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":1066},{"groupId":"EG001","numAffected":21,"numAtRisk":1052}]},{"term":"Blood creatine increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Blood glucose decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Blood glucose increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Blood iron decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Blood potassium decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Blood pressure diastolic increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Blood pressure increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":1066},{"groupId":"EG001","numAffected":23,"numAtRisk":1052}]},{"term":"Blood pressure systolic increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Blood thyroid stimulating hormone decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Blood thyroid stimulating hormone increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Blood triglycerides increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":1066},{"groupId":"EG001","numAffected":9,"numAtRisk":1052}]},{"term":"Blood uric acid increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Blood urine present","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Body temperature increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Bone density decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Breath sounds abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"C-reactive protein increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Cardiac murmur","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Electrocardiogram PR prolongation","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Electrocardiogram QT prolonged","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Electrocardiogram T wave amplitude decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Electrocardiogram abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Gamma-glutamyltransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Glycosylated haemoglobin increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Haematocrit decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Haemoglobin decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Heart rate increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Heart rate irregular","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Heart sounds abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Hepatic enzyme increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Intraocular pressure increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Lipids increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Liver function test abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Low density lipoprotein increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":1066},{"groupId":"EG001","numAffected":7,"numAtRisk":1052}]},{"term":"Mammogram abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Platelet count decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Protein total decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Protein urine present","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Smear cervix abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Thyroid function test abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Total cholesterol/HDL ratio decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Tuberculin test positive","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Urine analysis abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Urine ketone body present","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Urine output decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Very low density lipoprotein increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Vitamin B12 decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Vitamin D decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Weight decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":6,"numAtRisk":1052}]},{"term":"Weight increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":1066},{"groupId":"EG001","numAffected":33,"numAtRisk":1052}]},{"term":"White blood cell count decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"White blood cells urine","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":1066},{"groupId":"EG001","numAffected":8,"numAtRisk":1052}]},{"term":"Dehydration","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Diabetes mellitus","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Dyslipidaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Fluid retention","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Food craving","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Gout","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Hypercholesterolaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":1066},{"groupId":"EG001","numAffected":18,"numAtRisk":1052}]},{"term":"Hyperglycaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Hyperkalaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Hyperlipidaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":1066},{"groupId":"EG001","numAffected":7,"numAtRisk":1052}]},{"term":"Hyperphagia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Hyperphosphataemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Hypertriglyceridaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Hyperuricaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Hypoalbuminaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Hypocalcaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Hypokalaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Hypovolaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Increased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Lactose intolerance","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Metabolic syndrome","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Obesity","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Type 2 diabetes mellitus","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Vitamin B12 deficiency","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Vitamin D deficiency","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Arthralgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":64,"numAtRisk":1066},{"groupId":"EG001","numAffected":93,"numAtRisk":1052}]},{"term":"Arthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":1066},{"groupId":"EG001","numAffected":8,"numAtRisk":1052}]},{"term":"Axillary mass","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":81,"numAtRisk":1066},{"groupId":"EG001","numAffected":106,"numAtRisk":1052}]},{"term":"Bone disorder","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Bone pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Bunion","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Bursitis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Chondrocalcinosis pyrophosphate","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Coccydynia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Costochondritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Dupuytren's contracture","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Exostosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Flank pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Foot deformity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Groin pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Intervertebral disc degeneration","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Intervertebral disc protrusion","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Joint crepitation","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Joint range of motion decreased","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Joint stiffness","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Joint swelling","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":7,"numAtRisk":1052}]},{"term":"Ligamentitis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Monarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Muscle atrophy","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Muscle spasms","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":1066},{"groupId":"EG001","numAffected":40,"numAtRisk":1052}]},{"term":"Muscle tightness","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Muscle twitching","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Muscular weakness","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Musculoskeletal chest pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Musculoskeletal discomfort","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Musculoskeletal pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":1066},{"groupId":"EG001","numAffected":36,"numAtRisk":1052}]},{"term":"Musculoskeletal stiffness","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":1066},{"groupId":"EG001","numAffected":12,"numAtRisk":1052}]},{"term":"Myalgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":1066},{"groupId":"EG001","numAffected":46,"numAtRisk":1052}]},{"term":"Neck deformity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Neck pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":1066},{"groupId":"EG001","numAffected":46,"numAtRisk":1052}]},{"term":"Nodule on extremity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Osteitis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Osteochondrosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Osteopenia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Osteoporosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Pain in extremity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":71,"numAtRisk":1066},{"groupId":"EG001","numAffected":73,"numAtRisk":1052}]},{"term":"Pain in jaw","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Periarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Plantar fasciitis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Polyarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Rheumatoid arthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Rotator cuff syndrome","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Sensation of heaviness","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Spinal column stenosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Spinal osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Spondylitis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Spondylolisthesis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Synovial cyst","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Temporomandibular joint syndrome","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Tendonitis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":1066},{"groupId":"EG001","numAffected":7,"numAtRisk":1052}]},{"term":"Tenosynovitis stenosans","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Trigger finger","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Acrochordon","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Adrenal adenoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Basal cell carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Benign breast neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Benign neoplasm of bladder","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Benign neoplasm of thyroid gland","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Breast cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Eye naevus","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Fibroadenoma of breast","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Fibroma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Haemangioma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Lipoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Lipoma of breast","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Lung neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Melanocytic naevus","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Pharyngeal neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pituitary tumour","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pituitary tumour benign","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Seborrhoeic keratosis","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Thyroid neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Uterine leiomyoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Uterine neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Amnesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Aphonia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Ataxia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Autonomic nervous system imbalance","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Balance disorder","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Burning sensation","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Carotid artery occlusion","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Carpal tunnel syndrome","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Cervical myelopathy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Circadian rhythm sleep disorder","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Clonus","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Clumsiness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Cognitive disorder","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Complex regional pain syndrome","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Crying","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Decreased vibratory sense","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Disturbance in attention","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":1066},{"groupId":"EG001","numAffected":6,"numAtRisk":1052}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":207,"numAtRisk":1066},{"groupId":"EG001","numAffected":64,"numAtRisk":1052}]},{"term":"Dizziness postural","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Dysaesthesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Dysgeusia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Exertional headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Head titubation","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":332,"numAtRisk":1066},{"groupId":"EG001","numAffected":262,"numAtRisk":1052}]},{"term":"Hemicephalalgia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Hyperaesthesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Hypersomnia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Hypoaesthesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":1066},{"groupId":"EG001","numAffected":21,"numAtRisk":1052}]},{"term":"Intracranial aneurysm","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Lethargy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Loss of consciousness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Memory impairment","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Mental impairment","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Migraine","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":1066},{"groupId":"EG001","numAffected":18,"numAtRisk":1052}]},{"term":"Migraine with aura","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Multiple sclerosis","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Multiple sclerosis relapse","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Muscle spasticity","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Myoclonus","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Nerve compression","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Neuralgia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Neuropathy peripheral","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Paraesthesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":1066},{"groupId":"EG001","numAffected":12,"numAtRisk":1052}]},{"term":"Poor quality sleep","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Presyncope","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Psychomotor hyperactivity","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Radicular pain","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Radiculopathy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Restless legs syndrome","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Sciatica","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":8,"numAtRisk":1052}]},{"term":"Sedation","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Sinus headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":1066},{"groupId":"EG001","numAffected":35,"numAtRisk":1052}]},{"term":"Sleep phase rhythm disturbance","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Somnolence","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":59,"numAtRisk":1066},{"groupId":"EG001","numAffected":11,"numAtRisk":1052}]},{"term":"Syncope","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Tension headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":1066},{"groupId":"EG001","numAffected":9,"numAtRisk":1052}]},{"term":"Thoracic outlet syndrome","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Tremor","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":1066},{"groupId":"EG001","numAffected":6,"numAtRisk":1052}]},{"term":"Visual field defect","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Abnormal dreams","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":1066},{"groupId":"EG001","numAffected":7,"numAtRisk":1052}]},{"term":"Affect lability","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Aggression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Agitation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Anger","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Anhedonia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Anorgasmia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":1066},{"groupId":"EG001","numAffected":29,"numAtRisk":1052}]},{"term":"Apathy","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Attention deficit/hyperactivity disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Bradyphrenia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Bruxism","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Change in sustained attention","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Confusional state","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Decreased interest","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Depressed mood","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":1066},{"groupId":"EG001","numAffected":9,"numAtRisk":1052}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":1066},{"groupId":"EG001","numAffected":31,"numAtRisk":1052}]},{"term":"Depressive symptom","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Derealisation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Disorientation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Dissociation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Disturbance in sexual arousal","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Dysphoria","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Emotional disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Emotional distress","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Euphoric mood","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Feelings of worthlessness","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Frustration","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Impatience","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Initial insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":151,"numAtRisk":1066},{"groupId":"EG001","numAffected":88,"numAtRisk":1052}]},{"term":"Intentional drug misuse","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Libido decreased","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Logorrhoea","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Loss of libido","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Major depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Mental status changes","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Middle insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Mood altered","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":1066},{"groupId":"EG001","numAffected":7,"numAtRisk":1052}]},{"term":"Mood swings","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Nervousness","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Nightmare","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Obsessive-compulsive disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Orgasm abnormal","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Orgasmic sensation decreased","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Panic attack","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Post-traumatic stress disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Psychotic disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Restlessness","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Sleep disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Sleep talking","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Sleep terror","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Stress","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Suicidal ideation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Tearfulness","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Tension","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Terminal insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Thinking abnormal","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Tic","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Withdrawal syndrome","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Bladder discomfort","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Bladder irritation","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Bladder pain","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Bladder prolapse","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Bladder spasm","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Costovertebral angle tenderness","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Dysuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Haematuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":1066},{"groupId":"EG001","numAffected":13,"numAtRisk":1052}]},{"term":"Hypertonic bladder","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Incontinence","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Ketonuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Micturition urgency","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Nephrocalcinosis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Nephrolithiasis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":6,"numAtRisk":1052}]},{"term":"Nocturia","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pollakiuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":6,"numAtRisk":1052}]},{"term":"Polyuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Proteinuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pyuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Renal cyst","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Renal pain","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Residual urine","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Stress urinary incontinence","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Trigonitis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Urethral caruncle","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Urethral pain","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Urethral prolapse","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Urge incontinence","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Urinary hesitation","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Urinary incontinence","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Urinary retention","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Urine odour abnormal","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Atrophic vulvovaginitis","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Breast calcifications","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Breast cyst","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Breast discharge","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Breast disorder","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Breast dysplasia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Breast engorgement","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Breast mass","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Breast pain","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":7,"numAtRisk":1052}]},{"term":"Breast swelling","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Breast tenderness","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":14,"numAtRisk":1052}]},{"term":"Cervical discharge","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Cervical dysplasia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Cervical polyp","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Cervix disorder","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Coital bleeding","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Cystocele","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Dysmenorrhoea","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Dyspareunia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Endometrial hyperplasia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Genital discomfort","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Genital haemorrhage","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Genital rash","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Lactation disorder","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Menstrual disorder","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Menstruation irregular","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Metrorrhagia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Nipple pain","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Ovarian cyst","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Pelvic discomfort","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Pelvic pain","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Postmenopausal haemorrhage","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":8,"numAtRisk":1052}]},{"term":"Premenstrual syndrome","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pruritus genital","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Rectocele","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Sexual dysfunction","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Uterine cervix stenosis","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Uterine enlargement","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Uterine haemorrhage","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Uterine pain","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Uterine polyp","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Uterine prolapse","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Vaginal discharge","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Vaginal haemorrhage","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":1066},{"groupId":"EG001","numAffected":22,"numAtRisk":1052}]},{"term":"Vaginal stricture","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Vulva cyst","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Vulval disorder","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Vulvar erosion","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Vulvovaginal discomfort","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Vulvovaginal dryness","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Vulvovaginal erythema","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Vulvovaginal pruritus","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":5,"numAtRisk":1052}]},{"term":"Allergic sinusitis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Asthma","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Chronic obstructive pulmonary disease","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Cough","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":1066},{"groupId":"EG001","numAffected":45,"numAtRisk":1052}]},{"term":"Dry throat","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Dysphonia","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Dyspnoea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":1066},{"groupId":"EG001","numAffected":9,"numAtRisk":1052}]},{"term":"Dyspnoea exertional","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Epistaxis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":1066},{"groupId":"EG001","numAffected":10,"numAtRisk":1052}]},{"term":"Hiccups","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Laryngeal oedema","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Laryngeal polyp","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Nasal congestion","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":1066},{"groupId":"EG001","numAffected":20,"numAtRisk":1052}]},{"term":"Nasal disorder","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Nasal dryness","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Nasal ulcer","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Obliterative bronchiolitis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Oropharyngeal pain","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":59,"numAtRisk":1066},{"groupId":"EG001","numAffected":42,"numAtRisk":1052}]},{"term":"Paranasal sinus hypersecretion","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Pharyngeal erythema","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Pharyngeal oedema","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pleurisy","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Postnasal drip","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Productive cough","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Pulmonary congestion","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Respiratory tract congestion","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Rhinalgia","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Rhinitis allergic","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Rhinorrhoea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":1066},{"groupId":"EG001","numAffected":9,"numAtRisk":1052}]},{"term":"Rhonchi","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Sinus congestion","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":1066},{"groupId":"EG001","numAffected":28,"numAtRisk":1052}]},{"term":"Sinus polyp","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Sleep apnoea syndrome","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Sneezing","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Sputum discoloured","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Stridor","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Throat irritation","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Throat tightness","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Upper respiratory tract congestion","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":1066},{"groupId":"EG001","numAffected":13,"numAtRisk":1052}]},{"term":"Wheezing","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Yawning","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Acne","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1066},{"groupId":"EG001","numAffected":6,"numAtRisk":1052}]},{"term":"Acne cystic","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Actinic keratosis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Alopecia","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":1066},{"groupId":"EG001","numAffected":6,"numAtRisk":1052}]},{"term":"Blister","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Campbell de Morgan spots","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Cold sweat","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Dermal cyst","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Dermatitis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Dermatitis allergic","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Dermatitis contact","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":1066},{"groupId":"EG001","numAffected":12,"numAtRisk":1052}]},{"term":"Dermatosis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Dry skin","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":1066},{"groupId":"EG001","numAffected":4,"numAtRisk":1052}]},{"term":"Dyshidrosis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Ecchymosis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Eczema","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Erythema","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Erythema nodosum","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Hair texture abnormal","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Hidradenitis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Hirsutism","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Hyperhidrosis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":1066},{"groupId":"EG001","numAffected":8,"numAtRisk":1052}]},{"term":"Hypoaesthesia facial","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Increased tendency to bruise","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Ingrowing nail","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Keloid scar","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Lentigo","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Lichen planus","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Lichen sclerosus","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Nail disorder","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Nail dystrophy","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Night sweats","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":1066},{"groupId":"EG001","numAffected":14,"numAtRisk":1052}]},{"term":"Onychoclasis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pain of skin","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Photosensitivity reaction","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Pruritus","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":1066},{"groupId":"EG001","numAffected":13,"numAtRisk":1052}]},{"term":"Pruritus generalised","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Psoriasis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Rash","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":1066},{"groupId":"EG001","numAffected":25,"numAtRisk":1052}]},{"term":"Rash erythematous","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":3,"numAtRisk":1052}]},{"term":"Rash generalised","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Rash macular","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Rash maculo-papular","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Rash papular","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Rash pruritic","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Rosacea","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Scar","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Sebaceous hyperplasia","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Seborrhoeic dermatitis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Skin atrophy","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Skin discolouration","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Skin haemorrhage","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Skin hyperpigmentation","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Skin induration","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Skin irritation","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Skin lesion","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Skin nodule","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Skin swelling","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Subcutaneous nodule","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Swelling face","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Trichorrhexis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Urticaria","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":1066},{"groupId":"EG001","numAffected":10,"numAtRisk":1052}]},{"term":"Yellow skin","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Ex-tobacco user","organSystem":"Social circumstances","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Stress at work","organSystem":"Social circumstances","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Post procedural drainage","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Aortic dilatation","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Flushing","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Haematoma","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":2,"numAtRisk":1052}]},{"term":"Hot flush","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":95,"numAtRisk":1066},{"groupId":"EG001","numAffected":59,"numAtRisk":1052}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":1066},{"groupId":"EG001","numAffected":33,"numAtRisk":1052}]},{"term":"Hypotension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Orthostatic hypotension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Peripheral coldness","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Peripheral embolism","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Raynaud's phenomenon","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1066},{"groupId":"EG001","numAffected":0,"numAtRisk":1052}]},{"term":"Thrombosis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]},{"term":"Varicose vein","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1066},{"groupId":"EG001","numAffected":1,"numAtRisk":1052}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"GCS scales were analyzed only for main study efficacy population."},"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results."},"pointOfContact":{"title":"Pfizer ClinicalTrials.gov Call Center","organization":"Pfizer, Inc.","email":"ClinicalTrials.gov_Inquiries@pfizer.com","phone":"1-800-718-1021"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D019584","term":"Hot Flashes"}],"ancestors":[{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D000069468","term":"Desvenlafaxine Succinate"}],"ancestors":[{"id":"D003511","term":"Cyclohexanols"},{"id":"D000441","term":"Hexanols"},{"id":"D005233","term":"Fatty Alcohols"},{"id":"D000438","term":"Alcohols"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D003510","term":"Cyclohexanes"},{"id":"D003516","term":"Cycloparaffins"},{"id":"D006840","term":"Hydrocarbons, Alicyclic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D010636","term":"Phenols"},{"id":"D001555","term":"Benzene Derivatives"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D008055","term":"Lipids"}]}},"hasResults":true}