{"protocolSection":{"identificationModule":{"nctId":"NCT05971940","orgStudyIdInfo":{"id":"18564"},"secondaryIdInfos":[{"id":"J2A-MC-GZGT","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"U1111-1290-5157","type":"OTHER","domain":"UTN Number"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone","officialTitle":"A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone","acronym":"ACHIEVE-1"},"statusModule":{"statusVerifiedDate":"2026-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-08-09","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-04-03","type":"ACTUAL"},"completionDateStruct":{"date":"2025-04-03","type":"ACTUAL"},"studyFirstSubmitDate":"2023-07-25","studyFirstSubmitQcDate":"2023-07-25","studyFirstPostDateStruct":{"date":"2023-08-02","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-04-01","resultsFirstSubmitQcDate":"2026-04-01","resultsFirstPostDateStruct":{"date":"2026-04-22","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-08-13","lastUpdatePostDateStruct":{"date":"2026-09-03","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks."},"conditionsModule":{"conditions":["Type 2 Diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":559,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received once daily (QD) doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.","interventionNames":["Drug: Placebo"]},{"label":"3 mg Orforglipron","type":"EXPERIMENTAL","description":"Participants received orforglipron capsules administered orally QD, starting at 1 milligram (mg) and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.","interventionNames":["Drug: Orforglipron"]},{"label":"12 mg Orforglipron","type":"EXPERIMENTAL","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.","interventionNames":["Drug: Orforglipron"]},{"label":"36 mg Orforglipron","type":"EXPERIMENTAL","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.","interventionNames":["Drug: Orforglipron"]}],"interventions":[{"type":"DRUG","name":"Orforglipron","description":"Administered orally","armGroupLabels":["12 mg Orforglipron","3 mg Orforglipron","36 mg Orforglipron"],"otherNames":["LY3502970"]},{"type":"DRUG","name":"Placebo","description":"Administered orally","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in HbA1c","description":"* Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over prolonged periods of time.\n* Values represented under \"Least Squares (LS) Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ \\[less than or equal to\\] 8.0%, \\> \\[greater than\\] 8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"}],"secondaryOutcomes":[{"measure":"Percentage of Participants With an HbA1c Target Value of < 7.0% (53 mmol/Mol)","description":"Percentage of participants with an HbA1c target value of less than (\\<) 7.0% (53 millimoles per mole \\[mmol/mol\\]) was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no).","timeFrame":"Week 40"},{"measure":"Percentage of Participants With an HbA1c Target Value of ≤6.5% (48 mmol/Mol)","description":"Percentage of Participants with an HbA1c target value of less than or equal to (≤) 6.5% (48 mmol/mol) was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no).","timeFrame":"Week 40"},{"measure":"Change From Baseline in Fasting Serum Glucose (FSG)","description":"Values represented under \"Least Squares (LS) Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ \\[less than or equal to\\] 8.0%, \\> \\[greater than\\] 8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Percent Change From Baseline in Body Weight","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Change From Baseline in Body Weight","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Percent Change From Baseline in Non-High-Density Lipoprotein (Non-HDL) Cholesterol","description":"Values represented under \"Geometric LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis : log (Actual Measurement/Baseline) = country, treatment by time, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Percent Change From Baseline in Triglycerides","description":"Values represented under \"Geometric LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis : log (Actual Measurement/Baseline) = country, treatment by time, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)","description":"The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction","description":"Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no).","timeFrame":"Week 40"},{"measure":"Change From Baseline in Systolic Blood Pressure (SBP)","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores","description":"The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health \"now,\" whereas the remaining domains assess functioning \"in the past week.\" Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.","timeFrame":"Baseline, Week 40"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have Type 2 Diabetes\n* Have HbA1c ≥7.0% (53 mmol/mol) to ≤9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening.\n* Are naïve to insulin therapy except for gestational diabetes or ≤14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization.\n* Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.\n* Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.\n\nExclusion Criteria:\n\n* Have Type 1 Diabetes\n* Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.\n* Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema\n* Have New York Heart Association functional classification IV congestive heart failure.\n* Have acute or chronic pancreatitis","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Syed Research Consultants Llc","city":"Sheffield","state":"Alabama","zip":"35660","country":"United States","geoPoint":{"lat":34.76509,"lon":-87.69864}},{"facility":"Epic Medical Research - Surprise","city":"Surprise","state":"Arizona","zip":"85378","country":"United States","geoPoint":{"lat":33.63059,"lon":-112.33322}},{"facility":"Quality of Life Medical & Research Center","city":"Tucson","state":"Arizona","zip":"85712","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"facility":"Neighborhood Healthcare Institute of Health","city":"Escondido","state":"California","zip":"92025","country":"United States","geoPoint":{"lat":33.11921,"lon":-117.08642}},{"facility":"Velocity Clinical Research, Huntington Park","city":"Huntington Park","state":"California","zip":"90255","country":"United States","geoPoint":{"lat":33.98168,"lon":-118.22507}},{"facility":"Ark Clinical Research","city":"Long Beach","state":"California","zip":"90815","country":"United States","geoPoint":{"lat":33.76696,"lon":-118.18923}},{"facility":"Velocity Clinical Research, Westlake","city":"Los Angeles","state":"California","zip":"90057","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Infinity Clinical Research - Norco","city":"Norco","state":"California","zip":"92860","country":"United States","geoPoint":{"lat":33.93113,"lon":-117.54866}},{"facility":"Norcal Endocrinology & Internal Medicine","city":"San Ramon","state":"California","zip":"94583","country":"United States","geoPoint":{"lat":37.77993,"lon":-121.97802}},{"facility":"University Clinical Investigators, Inc.","city":"Tustin","state":"California","zip":"92780","country":"United States","geoPoint":{"lat":33.74585,"lon":-117.82617}},{"facility":"Connecticut Clinical Research - Cromwell","city":"Cromwell","state":"Connecticut","zip":"06416","country":"United States","geoPoint":{"lat":41.5951,"lon":-72.64537}},{"facility":"Invictus Clinical Research Group","city":"Coconut Creek","state":"Florida","zip":"33073","country":"United States","geoPoint":{"lat":26.25175,"lon":-80.17894}},{"facility":"Hillcrest Medical Research","city":"DeLand","state":"Florida","zip":"32720","country":"United States","geoPoint":{"lat":29.02832,"lon":-81.30312}},{"facility":"K2 Medical Research","city":"Maitland","state":"Florida","zip":"32751","country":"United States","geoPoint":{"lat":28.62778,"lon":-81.36312}},{"facility":"Global Health Research Center, Inc.","city":"Miami Lakes","state":"Florida","zip":"33016","country":"United States","geoPoint":{"lat":25.90871,"lon":-80.30866}},{"facility":"West Orange Endocrinology","city":"Ocoee","state":"Florida","zip":"34761","country":"United States","geoPoint":{"lat":28.56917,"lon":-81.54396}},{"facility":"Clinical Research Atlanta","city":"Stockbridge","state":"Georgia","zip":"30281","country":"United States","geoPoint":{"lat":33.54428,"lon":-84.23381}},{"facility":"Rophe Adult and Pediatric Medicine/SKYCRNG","city":"Union City","state":"Georgia","zip":"30291","country":"United States","geoPoint":{"lat":33.58706,"lon":-84.54243}},{"facility":"Family First Medical Center","city":"Idaho Falls","state":"Idaho","zip":"83404","country":"United States","geoPoint":{"lat":43.46658,"lon":-112.03414}},{"facility":"American Health Network of Indiana, LLC - Muncie","city":"Muncie","state":"Indiana","zip":"47304","country":"United States","geoPoint":{"lat":40.19338,"lon":-85.38636}},{"facility":"Tekton Research - Wichita","city":"Wichita","state":"Kansas","zip":"67218","country":"United States","geoPoint":{"lat":37.69224,"lon":-97.33754}},{"facility":"Alliance for Multispecialty Research, LLC","city":"New Orleans","state":"Louisiana","zip":"70119","country":"United States","geoPoint":{"lat":29.95465,"lon":-90.07507}},{"facility":"Revival Research Institute","city":"Dearborn","state":"Michigan","zip":"48126","country":"United States","geoPoint":{"lat":42.32226,"lon":-83.17631}},{"facility":"Billings Clinic","city":"Billings","state":"Montana","zip":"59101","country":"United States","geoPoint":{"lat":45.78329,"lon":-108.50069}},{"facility":"Ellipsis Research Group - Brooklyn - 7th Street","city":"Brooklyn","state":"New York","zip":"11215","country":"United States","geoPoint":{"lat":40.6501,"lon":-73.94958}},{"facility":"Central New York Clinical Research","city":"Manlius","state":"New York","zip":"13104","country":"United States","geoPoint":{"lat":43.00201,"lon":-75.97686}},{"facility":"Monroe Biomedical Research","city":"Monroe","state":"North Carolina","zip":"28112","country":"United States","geoPoint":{"lat":34.98543,"lon":-80.54951}},{"facility":"Lucas Research - New Bern","city":"New Bern","state":"North Carolina","zip":"28562","country":"United States","geoPoint":{"lat":35.10849,"lon":-77.04411}},{"facility":"Centricity Research Dublin Multispecialty","city":"Dublin","state":"Ohio","zip":"43016","country":"United States","geoPoint":{"lat":40.09923,"lon":-83.11408}},{"facility":"Alliance for Multispecialty Research, LLC","city":"Norman","state":"Oklahoma","zip":"73069","country":"United States","geoPoint":{"lat":35.22257,"lon":-97.43948}},{"facility":"The Corvallis Clinic, P.C.","city":"Corvallis","state":"Oregon","zip":"97330","country":"United States","geoPoint":{"lat":44.56457,"lon":-123.26204}},{"facility":"Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair","city":"Pittsburgh","state":"Pennsylvania","zip":"15243","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}},{"facility":"Preferred Primary Care Physicians","city":"Uniontown","state":"Pennsylvania","zip":"15401","country":"United States","geoPoint":{"lat":39.90008,"lon":-79.71643}},{"facility":"The Research Center of The Upstate","city":"Greenville","state":"South Carolina","zip":"29607","country":"United States","geoPoint":{"lat":34.85262,"lon":-82.39401}},{"facility":"MDFirst Research, LLC","city":"Lancaster","state":"South Carolina","zip":"29720","country":"United States","geoPoint":{"lat":34.72043,"lon":-80.7709}},{"facility":"The Jackson Clinic","city":"Jackson","state":"Tennessee","zip":"38305","country":"United States","geoPoint":{"lat":35.61452,"lon":-88.81395}},{"facility":"Velocity Clinical Research, Dallas","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Juno Research","city":"Houston","state":"Texas","zip":"77040","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Endocrine Ips, Pllc","city":"Houston","state":"Texas","zip":"77079","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Amir A Hassan, MD, PA","city":"Houston","state":"Texas","zip":"77089","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Burke Internal Medicine and Research","city":"Burke","state":"Virginia","zip":"22015","country":"United States","geoPoint":{"lat":38.79345,"lon":-77.27165}},{"facility":"Wannan Medical College Yijishan Hospital","city":"Wuhu","state":"Anhui","zip":"241001","country":"China","geoPoint":{"lat":31.35259,"lon":118.42947}},{"facility":"Luhe Hospital","city":"Beijing","state":"Beijing Municipality","zip":"100000","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Beijing Hospital","city":"Beijing","state":"Beijing Municipality","zip":"100730","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Beijing Pinggu District Hospital","city":"Beijing","state":"Beijing Municipality","zip":"101200","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Shunde Hospital of Southern Medical Univesity","city":"Foshan","state":"Guangdong","zip":"528399","country":"China","geoPoint":{"lat":23.02677,"lon":113.13148}},{"facility":"Huizhou Municipal Central Hospital","city":"Huizhou","state":"Guangdong","zip":"516001","country":"China","geoPoint":{"lat":23.11147,"lon":114.41523}},{"facility":"The Fourth Affiliated Hospital of Harbin Medical University","city":"Harbin","state":"Heilongjiang","zip":"150001","country":"China","geoPoint":{"lat":45.75,"lon":126.65}},{"facility":"Nanyang First People's Hospital","city":"Nanyang","state":"Henan","zip":"473001","country":"China","geoPoint":{"lat":33.00524,"lon":112.54659}},{"facility":"The Second Affiliated Hospital of Zhengzhou University","city":"Zhengzhou","state":"Henan","zip":"450014","country":"China","geoPoint":{"lat":34.75778,"lon":113.64861}},{"facility":"Nanjing First Hospital","city":"Nanjing","state":"Jiangsu","zip":"210006","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"The Second Affiliated Hospital of Nanjing Medical University","city":"Nanjing","state":"Jiangsu","zip":"210011","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"Affiliated Hospital of Jiangsu University","city":"Zhenjiang","state":"Jiangsu","zip":"212000","country":"China","geoPoint":{"lat":32.21086,"lon":119.45508}},{"facility":"Jinan Central Hospital","city":"Jinan","state":"Shandong","zip":"250013","country":"China","geoPoint":{"lat":36.66833,"lon":116.99722}},{"facility":"Pudong New Area People's Hospital Shanghai","city":"Shanghai","state":"Shanghai Municipality","zip":"201200","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"facility":"West China Hospital of Sichuan University","city":"Chengdu","state":"Sichuan","zip":"610041","country":"China","geoPoint":{"lat":30.66667,"lon":104.06667}},{"facility":"GMERS Medical College and General Hospital","city":"Vadodara","state":"Gujarat","zip":"390021","country":"India","geoPoint":{"lat":22.29941,"lon":73.20812}},{"facility":"M S Ramaiah Medical College and Hospitals","city":"Bangalore","state":"Karnataka","zip":"560054","country":"India","geoPoint":{"lat":12.97194,"lon":77.59369}},{"facility":"Medstar Speciality Hospital","city":"Bangalore","state":"Karnataka","zip":"560092","country":"India","geoPoint":{"lat":12.97194,"lon":77.59369}},{"facility":"BSES MG Hospital","city":"Mumbai","state":"Maharashtra","zip":"400058","country":"India","geoPoint":{"lat":19.07283,"lon":72.88261}},{"facility":"All India Institute of Medical Sciences (AIIMS) - Nagpur","city":"Nagpur","state":"Maharashtra","zip":"441108","country":"India","geoPoint":{"lat":21.14631,"lon":79.08491}},{"facility":"Grant Medical Foundation - Ruby Hall Clinic","city":"Pune","state":"Maharashtra","zip":"411001","country":"India","geoPoint":{"lat":18.51957,"lon":73.85535}},{"facility":"Madras Diabetes Research Foundation","city":"Chennai","state":"Tamil Nadu","zip":"600086","country":"India","geoPoint":{"lat":13.08784,"lon":80.27847}},{"facility":"Kumudini Devi Diabetes Research Center","city":"Hyderabad","state":"Telangana","zip":"500072","country":"India","geoPoint":{"lat":17.38405,"lon":78.45636}},{"facility":"Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital","city":"Kolkata","state":"West Bengal","zip":"700020","country":"India","geoPoint":{"lat":22.56263,"lon":88.36304}},{"facility":"Tokuyama Clinic","city":"Mihama-ku,Chiba City","state":"Chiba","zip":"261-0004","country":"Japan","geoPoint":{"lat":35.6,"lon":140.11667}},{"facility":"Steel Memorial Yahata Hospital","city":"Kitakyushu","state":"Fukuoka","zip":"805-8508","country":"Japan","geoPoint":{"lat":33.85181,"lon":130.85034}},{"facility":"Hasegawa Medical Clinic","city":"Chitose","state":"Hokkaido","zip":"066-0032","country":"Japan","geoPoint":{"lat":42.81944,"lon":141.65222}},{"facility":"MinamiAkatsukaClinic","city":"Mito","state":"Ibaraki","zip":"311-4153","country":"Japan","geoPoint":{"lat":36.35,"lon":140.45}},{"facility":"Iwamoto Clinic","city":"Zentsujichó","state":"Kagawa-ken","zip":"765-0071","country":"Japan","geoPoint":{"lat":34.22699,"lon":133.77791}},{"facility":"Hayashi Diabetes Internal Medicine Clinic","city":"Chigasaki","state":"Kanagawa","zip":"253-0044","country":"Japan","geoPoint":{"lat":35.33638,"lon":139.40434}},{"facility":"Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic","city":"Yamato-shi","state":"Kanagawa","zip":"242-0004","country":"Japan"},{"facility":"Medical Corporation Heishinkai OCROM Clinic","city":"Suita-shi","state":"Osaka","zip":"565-0853","country":"Japan"},{"facility":"The Institute of Medical Science, Asahi Life Foundation","city":"Chuo-ku","state":"Tokyo","zip":"103-0002","country":"Japan"},{"facility":"Tokyo-Eki Center-building Clinic","city":"Chuo-ku","state":"Tokyo","zip":"103-0027","country":"Japan"},{"facility":"Fukuwa Clinic","city":"Chuo-ku","state":"Tokyo","zip":"104-0031","country":"Japan"},{"facility":"Heishinkai Medical Group ToCROM Clinic","city":"Shinjuku-ku","state":"Tokyo","zip":"160-0008","country":"Japan"},{"facility":"Morinaga Ueno Clinic","city":"Kumamoto","zip":"860-0863","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"Abe Clinic","city":"Ōita","zip":"870-0039","country":"Japan","geoPoint":{"lat":33.23333,"lon":131.6}},{"facility":"Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente","city":"Guadalajara","state":"Jalisco","zip":"44150","country":"Mexico","geoPoint":{"lat":20.67738,"lon":-103.34749}},{"facility":"Centro de Investigacion Medica Integral","city":"Guadalajara","state":"Jalisco","zip":"44160","country":"Mexico","geoPoint":{"lat":20.67738,"lon":-103.34749}},{"facility":"Salud Cardiovascular","city":"Guadalajara","state":"Jalisco","zip":"44860","country":"Mexico","geoPoint":{"lat":20.67738,"lon":-103.34749}},{"facility":"Centro de Investigacion Medica de Occidente, S.C.","city":"Zapopan","state":"Jalisco","zip":"44260","country":"Mexico","geoPoint":{"lat":20.72111,"lon":-103.38742}},{"facility":"Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos","city":"Chihuahua City","zip":"31110","country":"Mexico","geoPoint":{"lat":28.63528,"lon":-106.08889}},{"facility":"PanAmerican Clinical Research - Querétaro - Avenida Antea","city":"Querétaro","zip":"76100","country":"Mexico","geoPoint":{"lat":15.83752,"lon":-92.75774}},{"facility":"Instituto Veracruzano en Investigación Clínica S.C.","city":"Veracruz","zip":"91851","country":"Mexico","geoPoint":{"lat":19.18095,"lon":-96.1429}},{"facility":"FAICIC S. de R.L. de C.V.","city":"Veracruz","zip":"91900","country":"Mexico","geoPoint":{"lat":19.18095,"lon":-96.1429}},{"facility":"Puerto Rico Health Institute","city":"Dorado","zip":"00646","country":"Puerto Rico","geoPoint":{"lat":18.45883,"lon":-66.26767}},{"facility":"Advance Medical Research Center","city":"San Juan","zip":"00926","country":"Puerto Rico","geoPoint":{"lat":18.46633,"lon":-66.10572}}]},"referencesModule":{"references":[{"pmid":"40544435","type":"DERIVED","citation":"Rosenstock J, Hsia S, Nevarez Ruiz L, Eyde S, Cox D, Wu WS, Liu R, Li J, Fernandez Lando L, Denning M, Ludwig L, Chen Y; ACHIEVE-1 Trial Investigators. Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 Diabetes. N Engl J Med. 2025 Sep 18;393(11):1065-1076. doi: 10.1056/NEJMoa2505669. Epub 2025 Jun 21."}],"seeAlsoLinks":[{"label":"A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (ACHIEVE-1)","url":"https://trials.lilly.com/en-US/trial/413375"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.","accessCriteria":"A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.","url":"http://vivli.org/"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"Participants received once daily (QD) doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks."},{"id":"FG001","title":"3 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 milligram (mg) and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40."},{"id":"FG002","title":"12 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40."},{"id":"FG003","title":"36 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"138"},{"groupId":"FG001","numSubjects":"143"},{"groupId":"FG002","numSubjects":"137"},{"groupId":"FG003","numSubjects":"141"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"138"},{"groupId":"FG001","numSubjects":"143"},{"groupId":"FG002","numSubjects":"137"},{"groupId":"FG003","numSubjects":"141"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"131"},{"groupId":"FG001","numSubjects":"134"},{"groupId":"FG002","numSubjects":"125"},{"groupId":"FG003","numSubjects":"136"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"12"},{"groupId":"FG003","numSubjects":"5"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Site Terminated By Sponsor","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Protocol Deviation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Participant not entering safety follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Non-Compliance With Study Drug","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Other - as reported by the investigator","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants.","groups":[{"id":"BG000","title":"Placebo","description":"Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks."},{"id":"BG001","title":"3 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40."},{"id":"BG002","title":"12 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40."},{"id":"BG003","title":"36 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"138"},{"groupId":"BG001","value":"143"},{"groupId":"BG002","value":"137"},{"groupId":"BG003","value":"141"},{"groupId":"BG004","value":"559"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"53.3","spread":"12.51"},{"groupId":"BG001","value":"53.3","spread":"11.28"},{"groupId":"BG002","value":"54.1","spread":"11.76"},{"groupId":"BG003","value":"52.8","spread":"11.83"},{"groupId":"BG004","value":"53.4","spread":"11.83"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"63"},{"groupId":"BG001","value":"63"},{"groupId":"BG002","value":"71"},{"groupId":"BG003","value":"72"},{"groupId":"BG004","value":"269"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"75"},{"groupId":"BG001","value":"80"},{"groupId":"BG002","value":"66"},{"groupId":"BG003","value":"69"},{"groupId":"BG004","value":"290"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"56"},{"groupId":"BG001","value":"57"},{"groupId":"BG002","value":"55"},{"groupId":"BG003","value":"55"},{"groupId":"BG004","value":"223"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"82"},{"groupId":"BG001","value":"86"},{"groupId":"BG002","value":"82"},{"groupId":"BG003","value":"85"},{"groupId":"BG004","value":"335"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"1"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"38"},{"groupId":"BG003","value":"35"},{"groupId":"BG004","value":"143"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"61"},{"groupId":"BG001","value":"63"},{"groupId":"BG002","value":"59"},{"groupId":"BG003","value":"62"},{"groupId":"BG004","value":"245"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"24"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"37"},{"groupId":"BG002","value":"30"},{"groupId":"BG003","value":"40"},{"groupId":"BG004","value":"145"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"China","categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"12"},{"groupId":"BG004","value":"51"}]}]},{"title":"India","categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"19"},{"groupId":"BG003","value":"22"},{"groupId":"BG004","value":"83"}]}]},{"title":"Japan","categories":[{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"25"},{"groupId":"BG004","value":"101"}]}]},{"title":"Mexico","categories":[{"measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"41"},{"groupId":"BG003","value":"40"},{"groupId":"BG004","value":"159"}]}]},{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"41"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"40"},{"groupId":"BG003","value":"42"},{"groupId":"BG004","value":"165"}]}]}]},{"title":"HemoglobinA1c (HbA1c)","description":"HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7.96","spread":"0.89"},{"groupId":"BG001","value":"7.93","spread":"0.86"},{"groupId":"BG002","value":"7.98","spread":"0.91"},{"groupId":"BG003","value":"8.07","spread":"0.90"},{"groupId":"BG004","value":"7.99","spread":"0.89"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in HbA1c","description":"* Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over prolonged periods of time.\n* Values represented under \"Least Squares (LS) Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ \\[less than or equal to\\] 8.0%, \\> \\[greater than\\] 8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40."},{"id":"OG002","title":"12 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40."},{"id":"OG003","title":"36 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"138"},{"groupId":"OG001","value":"143"},{"groupId":"OG002","value":"137"},{"groupId":"OG003","value":"141"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.15","spread":"0.113"},{"groupId":"OG001","value":"-1.26","spread":"0.114"},{"groupId":"OG002","value":"-1.59","spread":"0.087"},{"groupId":"OG003","value":"-1.45","spread":"0.104"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Square (LS) Mean Difference (Net)","paramValue":"-1.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.43","ciUpperLimit":"-0.80"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-1.44","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.72","ciUpperLimit":"-1.16"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-1.30","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.61","ciUpperLimit":"-1.00"}]},{"type":"SECONDARY","title":"Percentage of Participants With an HbA1c Target Value of < 7.0% (53 mmol/Mol)","description":"Percentage of participants with an HbA1c target value of less than (\\<) 7.0% (53 millimoles per mole \\[mmol/mol\\]) was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no).","populationDescription":"All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40."},{"id":"OG002","title":"12 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40."},{"id":"OG003","title":"36 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"112"},{"groupId":"OG003","value":"119"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37.11"},{"groupId":"OG001","value":"78.15"},{"groupId":"OG002","value":"81.25"},{"groupId":"OG003","value":"78.99"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"44.90","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"34.41","ciUpperLimit":"55.39"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"48.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"37.50","ciUpperLimit":"58.93"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"46.94","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"36.61","ciUpperLimit":"57.28"}]},{"type":"SECONDARY","title":"Percentage of Participants With an HbA1c Target Value of ≤6.5% (48 mmol/Mol)","description":"Percentage of Participants with an HbA1c target value of less than or equal to (≤) 6.5% (48 mmol/mol) was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no).","populationDescription":"All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40."},{"id":"OG002","title":"12 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40."},{"id":"OG003","title":"36 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"112"},{"groupId":"OG003","value":"119"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18.56"},{"groupId":"OG001","value":"66.39"},{"groupId":"OG002","value":"68.75"},{"groupId":"OG003","value":"68.91"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"48.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"38.47","ciUpperLimit":"57.55"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"48.79","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"39.11","ciUpperLimit":"58.47"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"52.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"42.88","ciUpperLimit":"62.09"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Serum Glucose (FSG)","description":"Values represented under \"Least Squares (LS) Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ \\[less than or equal to\\] 8.0%, \\> \\[greater than\\] 8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligram per deciliter (mg/dL)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40."},{"id":"OG002","title":"12 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40."},{"id":"OG003","title":"36 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"136"},{"groupId":"OG002","value":"130"},{"groupId":"OG003","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"4.01"},{"groupId":"OG001","value":"-30.6","spread":"3.66"},{"groupId":"OG002","value":"-37.4","spread":"3.08"},{"groupId":"OG003","value":"-37.8","spread":"2.94"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-29.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-40.1","ciUpperLimit":"-18.7"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-36.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-46.4","ciUpperLimit":"-26.3"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-36.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-46.6","ciUpperLimit":"-26.8"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Body Weight","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40."},{"id":"OG002","title":"12 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40."},{"id":"OG003","title":"36 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"138"},{"groupId":"OG001","value":"143"},{"groupId":"OG002","value":"137"},{"groupId":"OG003","value":"141"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.6","spread":"0.43"},{"groupId":"OG001","value":"-4.7","spread":"0.47"},{"groupId":"OG002","value":"-6.1","spread":"0.55"},{"groupId":"OG003","value":"-7.9","spread":"0.58"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-3.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.4","ciUpperLimit":"-1.8"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-4.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.9","ciUpperLimit":"-3.1"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-6.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.7","ciUpperLimit":"-4.8"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilogram (kg)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40."},{"id":"OG002","title":"12 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40."},{"id":"OG003","title":"36 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"138"},{"groupId":"OG001","value":"143"},{"groupId":"OG002","value":"137"},{"groupId":"OG003","value":"141"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"0.36"},{"groupId":"OG001","value":"-4.4","spread":"0.43"},{"groupId":"OG002","value":"-5.5","spread":"0.49"},{"groupId":"OG003","value":"-7.3","spread":"0.55"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-3.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.2","ciUpperLimit":"-2.0"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-4.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.5","ciUpperLimit":"-3.0"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-6.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.3","ciUpperLimit":"-4.6"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Non-High-Density Lipoprotein (Non-HDL) Cholesterol","description":"Values represented under \"Geometric LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis : log (Actual Measurement/Baseline) = country, treatment by time, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40."},{"id":"OG002","title":"12 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40."},{"id":"OG003","title":"36 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"135"},{"groupId":"OG001","value":"136"},{"groupId":"OG002","value":"131"},{"groupId":"OG003","value":"137"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.19","spread":"2.085"},{"groupId":"OG001","value":"-1.82","spread":"2.193"},{"groupId":"OG002","value":"-4.80","spread":"2.273"},{"groupId":"OG003","value":"-7.91","spread":"1.760"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.100","statisticalMethod":"Mixed Models Analysis","paramType":"Geometric LS Mean Difference (Net)","paramValue":"-4.85","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-10.33","ciUpperLimit":"0.96"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.010","statisticalMethod":"Mixed Models Analysis","paramType":"Geometric LS Mean Difference (Net)","paramValue":"-7.75","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-13.26","ciUpperLimit":"-1.88"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"Geometric LS Mean Difference (Net)","paramValue":"-10.76","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-15.53","ciUpperLimit":"-5.71"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Triglycerides","description":"Values represented under \"Geometric LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis : log (Actual Measurement/Baseline) = country, treatment by time, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40."},{"id":"OG002","title":"12 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40."},{"id":"OG003","title":"36 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"135"},{"groupId":"OG001","value":"136"},{"groupId":"OG002","value":"130"},{"groupId":"OG003","value":"136"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"3.56"},{"groupId":"OG001","value":"-9.1","spread":"3.61"},{"groupId":"OG002","value":"-16.5","spread":"3.06"},{"groupId":"OG003","value":"-14.0","spread":"2.84"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.072","statisticalMethod":"Mixed Models Analysis","paramType":"Geometric LS Mean Difference (Net)","paramValue":"-9.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-18.3","ciUpperLimit":"0.9"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"Geometric LS Mean Difference (Net)","paramValue":"-16.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-24.5","ciUpperLimit":"-7.7"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.002","statisticalMethod":"Mixed Models Analysis","paramType":"Geometric LS Mean Difference (Net)","paramValue":"-14.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-22.0","ciUpperLimit":"-5.3"}]},{"type":"SECONDARY","title":"Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)","description":"The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligram per deciliter (mg/dL)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40."},{"id":"OG002","title":"12 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40."},{"id":"OG003","title":"36 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"138"},{"groupId":"OG002","value":"129"},{"groupId":"OG003","value":"130"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-17.6","spread":"3.99"},{"groupId":"OG001","value":"-43.6","spread":"3.73"},{"groupId":"OG002","value":"-56.0","spread":"2.29"},{"groupId":"OG003","value":"-58.1","spread":"1.80"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-26.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-36.8","ciUpperLimit":"-15.1"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-38.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-47.7","ciUpperLimit":"-29.2"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-40.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-49.3","ciUpperLimit":"-31.7"}]},{"type":"SECONDARY","title":"Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction","description":"Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no).","populationDescription":"All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40."},{"id":"OG002","title":"12 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40."},{"id":"OG003","title":"36 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"111"},{"groupId":"OG003","value":"119"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14.58"},{"groupId":"OG001","value":"47.06"},{"groupId":"OG002","value":"58.56"},{"groupId":"OG003","value":"66.39"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"25.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"14.25","ciUpperLimit":"36.47"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"37.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"26.05","ciUpperLimit":"48.50"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"44.80","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"33.54","ciUpperLimit":"56.06"}]},{"type":"SECONDARY","title":"Change From Baseline in Systolic Blood Pressure (SBP)","description":"Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40."},{"id":"OG002","title":"12 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40."},{"id":"OG003","title":"36 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"138"},{"groupId":"OG001","value":"143"},{"groupId":"OG002","value":"137"},{"groupId":"OG003","value":"141"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.88"},{"groupId":"OG001","value":"-3.2","spread":"0.91"},{"groupId":"OG002","value":"-6.1","spread":"0.97"},{"groupId":"OG003","value":"-6.0","spread":"0.91"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.031","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-2.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.2","ciUpperLimit":"-0.2"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-5.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.2","ciUpperLimit":"-3.0"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-5.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.0","ciUpperLimit":"-3.0"}]},{"type":"SECONDARY","title":"Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores","description":"The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health \"now,\" whereas the remaining domains assess functioning \"in the past week.\" Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.","populationDescription":"All randomized participants who had evaluable data for this specific outcome. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of additional antihyperglycemic medications ( \\> 14 days of use).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"T-score","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"Placebo","description":"Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks."},{"id":"OG001","title":"3 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40."},{"id":"OG002","title":"12 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40."},{"id":"OG003","title":"36 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"136"},{"groupId":"OG001","value":"143"},{"groupId":"OG002","value":"137"},{"groupId":"OG003","value":"139"}]}],"classes":[{"title":"Physical Component Score","categories":[{"measurements":[{"groupId":"OG000","value":"2.25","spread":"0.592"},{"groupId":"OG001","value":"2.06","spread":"0.513"},{"groupId":"OG002","value":"2.21","spread":"0.574"},{"groupId":"OG003","value":"1.58","spread":"0.632"}]}]},{"title":"Mental Component Score","categories":[{"measurements":[{"groupId":"OG000","value":"0.09","spread":"0.689"},{"groupId":"OG001","value":"0.11","spread":"0.687"},{"groupId":"OG002","value":"-0.37","spread":"0.587"},{"groupId":"OG003","value":"-0.46","spread":"0.777"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Physical Component Score - Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an Analysis of Covariance (ANCOVA) with country, treatment by baseline, and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no).","nonInferiorityType":"SUPERIORITY","pValue":"0.801","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"-0.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.63","ciUpperLimit":"1.26"},{"groupIds":["OG000","OG002"],"groupDescription":"Physical Component Score - Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an ANCOVA with country, treatment by baseline, and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no).","nonInferiorityType":"SUPERIORITY","pValue":"0.964","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"-0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.61","ciUpperLimit":"1.54"},{"groupIds":["OG000","OG003"],"groupDescription":"Physical Component Score - Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an ANCOVA with country, treatment by baseline, and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no).","nonInferiorityType":"SUPERIORITY","pValue":"0.410","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"-0.66","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.25","ciUpperLimit":"0.92"},{"groupIds":["OG000","OG001"],"groupDescription":"Mental Component Score - Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an ANCOVA with country, treatment by baseline, and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no).","nonInferiorityType":"SUPERIORITY","pValue":"0.990","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.89","ciUpperLimit":"1.91"},{"groupIds":["OG000","OG002"],"groupDescription":"Mental Component Score - Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an ANCOVA with country, treatment by baseline, and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no).","nonInferiorityType":"SUPERIORITY","pValue":"0.592","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"-0.46","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.17","ciUpperLimit":"1.24"},{"groupIds":["OG000","OG003"],"groupDescription":"Mental Component Score - Values represented under \"LS Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an ANCOVA with country, treatment by baseline, and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, \\>8.0%) and prior use of any antihyperglycemic medication (yes or no).","nonInferiorityType":"SUPERIORITY","pValue":"0.571","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"-0.56","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.49","ciUpperLimit":"1.37"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Baseline to end of safety follow-up (up to 42 weeks)","description":"* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses.\n* Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Participants received QD doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.","deathsNumAffected":1,"deathsNumAtRisk":138,"seriousNumAffected":5,"seriousNumAtRisk":138,"otherNumAffected":110,"otherNumAtRisk":138},{"id":"EG001","title":"3 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.","deathsNumAffected":2,"deathsNumAtRisk":143,"seriousNumAffected":8,"seriousNumAtRisk":143,"otherNumAffected":118,"otherNumAtRisk":143},{"id":"EG002","title":"12 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.","deathsNumAffected":1,"deathsNumAtRisk":137,"seriousNumAffected":7,"seriousNumAtRisk":137,"otherNumAffected":118,"otherNumAtRisk":137},{"id":"EG003","title":"36 mg Orforglipron","description":"Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.","deathsNumAffected":0,"deathsNumAtRisk":141,"seriousNumAffected":4,"seriousNumAtRisk":141,"otherNumAffected":123,"otherNumAtRisk":141}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Angina pectoris","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Cardiac failure","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Haemorrhoids","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Pyrexia","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Anal abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Diabetic foot infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Diverticulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":1,"numAtRisk":141}]},{"term":"Influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Sepsis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Septic shock","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Contusion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Heat illness","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Spinal compression fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Dehydration","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Arthralgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Intervertebral disc protrusion","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Lumbar spinal stenosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Lung neoplasm malignant","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Cerebral infarction","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Ischaemic stroke","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Presyncope","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Ectopic pregnancy","organSystem":"Pregnancy, puerperium and perinatal conditions","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":71},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":72}]},{"term":"Hydronephrosis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Ureterolithiasis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]}],"otherEvents":[{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Leukocytosis","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Polycythaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Splenomegaly","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Thrombocytopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Thrombocytosis","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Angina pectoris","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Atrioventricular block first degree","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Atrioventricular block second degree","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Bundle branch block left","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Bundle branch block right","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Left atrial enlargement","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Left ventricular hypertrophy","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Myocardial ischaemia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Rhythm idioventricular","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Sinus arrhythmia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Sinus bradycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Supraventricular extrasystoles","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Supraventricular tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Ventricular arrhythmia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Gilbert's syndrome","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Deafness bilateral","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Ear pruritus","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Eustachian tube dysfunction","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Middle ear effusion","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Goitre","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Thyroid mass","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Age-related macular degeneration","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Arteriosclerotic retinopathy","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Astigmatism","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Blepharitis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Blindness unilateral","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Cataract","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Cataract cortical","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Cataract nuclear","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Central serous chorioretinopathy","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Chalazion","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Conjunctival haemorrhage","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Conjunctivitis allergic","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Diabetic retinal oedema","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":3,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":5,"numAffected":2,"numAtRisk":141}]},{"term":"Diabetic retinopathy","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":35,"numAffected":21,"numAtRisk":138},{"groupId":"EG001","numEvents":37,"numAffected":21,"numAtRisk":143},{"groupId":"EG002","numEvents":18,"numAffected":8,"numAtRisk":137},{"groupId":"EG003","numEvents":46,"numAffected":24,"numAtRisk":141}]},{"term":"Dry eye","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Eczema eyelids","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Epiretinal membrane","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":1,"numAtRisk":141}]},{"term":"Eye pain","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Eyelid ptosis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Foreign body sensation in eyes","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Glaucoma","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Lenticular opacities","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Macular degeneration","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Macular oedema","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Ocular discomfort","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Ocular hyperaemia","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Ophthalmic artery occlusion","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Optic disc haemorrhage","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Pathologic myopia","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Retinal degeneration","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Retinal detachment","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Retinopathy hypertensive","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Vision blurred","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Visual acuity reduced","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Vitreous detachment","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Abdominal discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":6,"numAffected":4,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":11,"numAtRisk":138},{"groupId":"EG001","numEvents":10,"numAffected":6,"numAtRisk":143},{"groupId":"EG002","numEvents":8,"numAffected":7,"numAtRisk":137},{"groupId":"EG003","numEvents":22,"numAffected":16,"numAtRisk":141}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":137},{"groupId":"EG003","numEvents":8,"numAffected":7,"numAtRisk":141}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":13,"numAffected":8,"numAtRisk":137},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":141}]},{"term":"Anal fissure","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Chronic gastritis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Colitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":10,"numAffected":5,"numAtRisk":138},{"groupId":"EG001","numEvents":14,"numAffected":12,"numAtRisk":143},{"groupId":"EG002","numEvents":29,"numAffected":23,"numAtRisk":137},{"groupId":"EG003","numEvents":22,"numAffected":20,"numAtRisk":141}]},{"term":"Dental caries","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":18,"numAffected":13,"numAtRisk":138},{"groupId":"EG001","numEvents":61,"numAffected":27,"numAtRisk":143},{"groupId":"EG002","numEvents":43,"numAffected":29,"numAtRisk":137},{"groupId":"EG003","numEvents":81,"numAffected":36,"numAtRisk":141}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":13,"numAffected":10,"numAtRisk":138},{"groupId":"EG001","numEvents":20,"numAffected":17,"numAtRisk":143},{"groupId":"EG002","numEvents":42,"numAffected":29,"numAtRisk":137},{"groupId":"EG003","numEvents":31,"numAffected":22,"numAtRisk":141}]},{"term":"Epigastric discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Eructation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":13,"numAffected":5,"numAtRisk":143},{"groupId":"EG002","numEvents":10,"numAffected":6,"numAtRisk":137},{"groupId":"EG003","numEvents":22,"numAffected":10,"numAtRisk":141}]},{"term":"Faeces hard","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Flatulence","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":9,"numAffected":3,"numAtRisk":143},{"groupId":"EG002","numEvents":3,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":5,"numAffected":5,"numAtRisk":141}]},{"term":"Food poisoning","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Functional gastrointestinal disorder","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Gastritis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":141}]},{"term":"Gastritis erosive","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Gastrointestinal disorder","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Gastrointestinal inflammation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Gastrooesophageal reflux disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":143},{"groupId":"EG002","numEvents":9,"numAffected":7,"numAtRisk":137},{"groupId":"EG003","numEvents":7,"numAffected":7,"numAtRisk":141}]},{"term":"Haematochezia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Haemorrhoids","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Hiatus hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Hyperchlorhydria","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Hyperechogenic pancreas","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Infrequent bowel movements","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Inguinal hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Irritable bowel syndrome","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Large intestine polyp","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":138},{"groupId":"EG001","numEvents":23,"numAffected":18,"numAtRisk":143},{"groupId":"EG002","numEvents":30,"numAffected":26,"numAtRisk":137},{"groupId":"EG003","numEvents":34,"numAffected":24,"numAtRisk":141}]},{"term":"Oesophagitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Paraesthesia oral","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Regurgitation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Stomatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Swollen tongue","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Tooth impacted","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Toothache","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":9,"numAffected":7,"numAtRisk":143},{"groupId":"EG002","numEvents":11,"numAffected":9,"numAtRisk":137},{"groupId":"EG003","numEvents":43,"numAffected":20,"numAtRisk":141}]},{"term":"Adverse drug reaction","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Asthenia","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Chest discomfort","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Chills","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Early satiety","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":138},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":141}]},{"term":"Feeling abnormal","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Hyperthermia","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Non-cardiac chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Oedema","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Oedema peripheral","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Peripheral swelling","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Pyrexia","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":138},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":143},{"groupId":"EG002","numEvents":6,"numAffected":6,"numAtRisk":137},{"groupId":"EG003","numEvents":4,"numAffected":3,"numAtRisk":141}]},{"term":"Swelling face","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Temperature intolerance","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Thirst","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Vaccination site pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Cholecystitis acute","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Hepatic cirrhosis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Hepatic function abnormal","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Hepatic steatosis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Hepatitis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Hepatomegaly","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Hyperplastic cholecystopathy","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Metabolic dysfunction-associated liver disease","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Portal hypertension","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Hypersensitivity","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Seasonal allergy","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Acarodermatitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Acute sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Anal abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Bacterial vaginosis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":63},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":71},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":72}]},{"term":"Body tinea","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Bronchiolitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Bronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Cervicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":63},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":71},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":72}]},{"term":"Conjunctivitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Coronavirus infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Covid-19","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":137},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":141}]},{"term":"Cystitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Dengue fever","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":5,"numAffected":5,"numAtRisk":141}]},{"term":"Dengue haemorrhagic fever","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Dermatophytosis of nail","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Ear infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Fungal infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":141}]},{"term":"Gastroenteritis viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Gastrointestinal fungal infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Gastrointestinal infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Gingival abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Gingivitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Herpes ophthalmic","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Herpes zoster","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Hordeolum","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":3,"numAffected":2,"numAtRisk":141}]},{"term":"Influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":5,"numAffected":5,"numAtRisk":137},{"groupId":"EG003","numEvents":3,"numAffected":2,"numAtRisk":141}]},{"term":"Laryngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":8,"numAtRisk":138},{"groupId":"EG001","numEvents":7,"numAffected":5,"numAtRisk":143},{"groupId":"EG002","numEvents":13,"numAffected":10,"numAtRisk":137},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":141}]},{"term":"Norovirus infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Onychomycosis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Oral candidiasis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Oral herpes","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Otitis externa","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Otitis media","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Parotitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Pelvic inflammatory disease","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":71},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":72}]},{"term":"Periodontitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":1,"numAtRisk":141}]},{"term":"Pharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Pharyngitis bacterial","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Pharyngotonsillitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Pulpitis dental","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Respiratory tract infection viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Skin bacterial infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Skin infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Staphylococcal infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Tinea pedis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Tonsillitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Tooth abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Tooth infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":138},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":143},{"groupId":"EG002","numEvents":5,"numAffected":3,"numAtRisk":137},{"groupId":"EG003","numEvents":4,"numAffected":3,"numAtRisk":141}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":143},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":137},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":141}]},{"term":"Viral infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Viral pharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Viral upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Vulvovaginal candidiasis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":71},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":72}]},{"term":"Vulvovaginal mycotic infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":71},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":72}]},{"term":"Animal scratch","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Arthropod bite","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Back injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":3,"numAffected":1,"numAtRisk":141}]},{"term":"Cartilage injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Concussion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Craniofacial fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":1,"numAtRisk":141}]},{"term":"Eye contusion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Eyelid injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Fall","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Fibula fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Hand fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Immunisation reaction","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Ligament rupture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Ligament sprain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":138},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Limb injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Muscle strain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Poisoning","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Road traffic accident","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Shoulder fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Skin laceration","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Thermal burn","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Tooth fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Alanine aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Albumin urine present","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":3,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Amylase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":4,"numAffected":3,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Aspartate aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Blood alkaline phosphatase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Blood bilirubin increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Blood creatine increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Blood creatine phosphokinase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":6,"numAtRisk":138},{"groupId":"EG001","numEvents":4,"numAffected":3,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Blood creatinine increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Blood homocysteine increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Blood potassium decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":1,"numAtRisk":141}]},{"term":"Blood potassium increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Blood pressure increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":4,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Blood uric acid increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"C-reactive protein increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Capillary fragility increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Colonoscopy","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Creatinine urine increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Electrocardiogram abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Electrocardiogram t wave abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Fibrin d dimer increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Gamma-glutamyltransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":7,"numAffected":4,"numAtRisk":143},{"groupId":"EG002","numEvents":3,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Glomerular filtration rate decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":5,"numAtRisk":138},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Haematocrit increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Haemoglobin decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Heart rate increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Hepatic enzyme increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Lipase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":138},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":143},{"groupId":"EG002","numEvents":9,"numAffected":7,"numAtRisk":137},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":141}]},{"term":"Mean cell volume increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Occult blood positive","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Pancreatic enzymes increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Platelet count increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Protein total increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Protein urine present","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Qrs axis abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":1,"numAtRisk":141}]},{"term":"Sars-cov-2 test positive","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Transaminases increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":1,"numAtRisk":141}]},{"term":"Urinary occult blood","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Weight decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Weight increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":138},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":143},{"groupId":"EG002","numEvents":18,"numAffected":14,"numAtRisk":137},{"groupId":"EG003","numEvents":22,"numAffected":17,"numAtRisk":141}]},{"term":"Dehydration","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":9,"numAffected":1,"numAtRisk":141}]},{"term":"Dyslipidaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":138},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":7,"numAffected":7,"numAtRisk":141}]},{"term":"Hypercholesterolaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Hyperglycaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":39,"numAffected":37,"numAtRisk":138},{"groupId":"EG001","numEvents":12,"numAffected":11,"numAtRisk":143},{"groupId":"EG002","numEvents":8,"numAffected":6,"numAtRisk":137},{"groupId":"EG003","numEvents":10,"numAffected":9,"numAtRisk":141}]},{"term":"Hyperkalaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Hyperlipidaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":137},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":141}]},{"term":"Hypertriglyceridaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":141}]},{"term":"Hyperuricaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":137},{"groupId":"EG003","numEvents":4,"numAffected":3,"numAtRisk":141}]},{"term":"Hypocalcaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Hypokalaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":3,"numAffected":2,"numAtRisk":141}]},{"term":"Hypophosphataemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Increased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Metabolic disorder","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Obesity","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Overweight","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Type 2 diabetes mellitus","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Arthralgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":12,"numAffected":3,"numAtRisk":143},{"groupId":"EG002","numEvents":5,"numAffected":5,"numAtRisk":137},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":141}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":5,"numAffected":5,"numAtRisk":141}]},{"term":"Costochondritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Intervertebral disc displacement","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Intervertebral disc protrusion","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Joint swelling","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Muscle contracture","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Muscle spasms","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Musculoskeletal chest pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":3,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Musculoskeletal pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Myalgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Pain in extremity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":7,"numAffected":3,"numAtRisk":143},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Periarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":1,"numAtRisk":141}]},{"term":"Plantar fasciitis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Polymyalgia rheumatica","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Spinal ligament ossification","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Spinal osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Spondylolisthesis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Synovial cyst","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Tendonitis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Tenosynovitis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Vertebral foraminal stenosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Dysplastic naevus","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Lipoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Pyogenic granuloma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Seborrhoeic keratosis","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Uterine leiomyoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":71},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":72}]},{"term":"Bell's palsy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Brain fog","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Brain oedema","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Burning sensation","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Carotid arteriosclerosis","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Cerebral arteriosclerosis","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Cerebral artery stenosis","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Cerebral infarction","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Cervical cord compression","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Cervical radiculopathy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":3,"numAffected":1,"numAtRisk":141}]},{"term":"Cubital tunnel syndrome","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Diabetic neuropathy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":6,"numAffected":6,"numAtRisk":143},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":137},{"groupId":"EG003","numEvents":5,"numAffected":5,"numAtRisk":141}]},{"term":"Dizziness postural","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Dysgeusia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":8,"numAtRisk":138},{"groupId":"EG001","numEvents":11,"numAffected":10,"numAtRisk":143},{"groupId":"EG002","numEvents":8,"numAffected":8,"numAtRisk":137},{"groupId":"EG003","numEvents":11,"numAffected":11,"numAtRisk":141}]},{"term":"Hemiparesis","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Hypoaesthesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":4,"numAffected":3,"numAtRisk":141}]},{"term":"Increased need for sleep","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Lhermitte's sign","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Migraine","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Nerve compression","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Neuralgia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Neurodegenerative disorder","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Paraesthesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Sciatica","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Somnolence","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Syncope","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Taste disorder","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Tension headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Transient ischaemic attack","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Tremor","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Abnormal dreams","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Anger","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Anxiety disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Depressed mood","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":4,"numAtRisk":138},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":143},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Libido decreased","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Nervousness","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Stress","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Acute kidney injury","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Albuminuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Chromaturia","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Chronic kidney disease","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Diabetic nephropathy","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":138},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":143},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":137},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":141}]},{"term":"Microalbuminuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Nephrolithiasis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Pollakiuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Proteinuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Renal cyst","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Renal impairment","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":138},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":143},{"groupId":"EG002","numEvents":4,"numAffected":3,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Renal mass","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Atrophic vulvovaginitis","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":63},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":71},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":72}]},{"term":"Benign prostatic hyperplasia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":80},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":69}]},{"term":"Dysmenorrhoea","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":71},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":72}]},{"term":"Intermenstrual bleeding","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":71},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":72}]},{"term":"Pelvic adhesions","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Vaginal haemorrhage","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":63},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":71},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":72}]},{"term":"Asthma","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Cough","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":141}]},{"term":"Dyspnoea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Hiccups","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Nasal congestion","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Oropharyngeal pain","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Productive cough","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Pulmonary pain","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Rhinitis allergic","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Rhinorrhoea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Sinus congestion","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Tonsillar inflammation","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Upper respiratory tract inflammation","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Acne","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Actinic keratosis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Alopecia","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":141}]},{"term":"Cold urticaria","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Dermatitis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Dry skin","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Eczema","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Erythema","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Ingrowing nail","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Miliaria","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Onychalgia","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Panniculitis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Pruritus","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Rash","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Skin burning sensation","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Skin discharge","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Skin lesion","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Skin ulcer","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Urticaria","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Family stress","organSystem":"Social circumstances","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Overwork","organSystem":"Social circumstances","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Drainage","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Extracorporeal shock wave therapy","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Eye laser surgery","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Iridotomy","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Polypectomy","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Retinal laser coagulation","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Aortic arteriosclerosis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Aortic stenosis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Blood pressure inadequately controlled","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":8,"numAtRisk":138},{"groupId":"EG001","numEvents":6,"numAffected":6,"numAtRisk":143},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":137},{"groupId":"EG003","numEvents":6,"numAffected":5,"numAtRisk":141}]},{"term":"Hypotension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":137},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":141}]},{"term":"Orthostatic hypotension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":143},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Peripheral venous disease","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]},{"term":"Varicose vein","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":138},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":143},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":137},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":141}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"GT60","restrictiveAgreement":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","email":"ClinicalTrials.gov@lilly.com","phone":"800-545-5979"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2023-09-06","uploadDate":"2026-01-06T05:20","filename":"Prot_000.pdf","size":18431618},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2025-03-14","uploadDate":"2026-01-06T05:21","filename":"SAP_001.pdf","size":8982471}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"}],"ancestors":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"C000729680","term":"orforglipron"}]}},"hasResults":true}