{"protocolSection":{"identificationModule":{"nctId":"NCT01468181","orgStudyIdInfo":{"id":"13991"},"secondaryIdInfos":[{"id":"H9X-JE-GBDQ","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus","officialTitle":"A 52-Week, Open-Label, Long-Term Safety Study of LY2189265 in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2015-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-11"},"primaryCompletionDateStruct":{"date":"2013-12","type":"ACTUAL"},"completionDateStruct":{"date":"2013-12","type":"ACTUAL"},"studyFirstSubmitDate":"2011-11-07","studyFirstSubmitQcDate":"2011-11-07","studyFirstPostDateStruct":{"date":"2011-11-09","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-12-08","resultsFirstSubmitQcDate":"2014-12-08","resultsFirstPostDateStruct":{"date":"2014-12-16","type":"ESTIMATED"},"dispFirstSubmitDate":"2014-04-14","dispFirstSubmitQcDate":"2014-04-14","dispFirstPostDateStruct":{"date":"2014-05-07","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-01-16","lastUpdatePostDateStruct":{"date":"2015-01-29","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM)."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["Type 2 diabetes mellitus","Oral antihyperglycemic medications","Long-Term Safety","GLP 1","Glucagon like peptide 1"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":394,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"LY2189265 + Sulfonylureas (SU)","type":"EXPERIMENTAL","description":"LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.","interventionNames":["Drug: LY2189265","Drug: Sulfonylureas (SU)"]},{"label":"LY2189265 + Biguanides (BG)","type":"EXPERIMENTAL","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.","interventionNames":["Drug: LY2189265","Drug: Biguanides (BG)"]},{"label":"LY2189265 + alpha-glucosidase inhibitor (a-GI)","type":"EXPERIMENTAL","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.","interventionNames":["Drug: LY2189265","Drug: alpha-glucosidase inhibitor (a-GI)"]},{"label":"LY2189265 + Thiazolidinedione (TZD)","type":"EXPERIMENTAL","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.","interventionNames":["Drug: LY2189265","Drug: Thiazolidinedione (TZD)"]},{"label":"LY2189265 + Glinides","type":"EXPERIMENTAL","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.","interventionNames":["Drug: LY2189265","Drug: Glinides"]}],"interventions":[{"type":"DRUG","name":"LY2189265","armGroupLabels":["LY2189265 + Biguanides (BG)","LY2189265 + Glinides","LY2189265 + Sulfonylureas (SU)","LY2189265 + Thiazolidinedione (TZD)","LY2189265 + alpha-glucosidase inhibitor (a-GI)"],"otherNames":["Dulaglutide"]},{"type":"DRUG","name":"Sulfonylureas (SU)","description":"SU is a pre-study prescribed dose and is not being provided as part of the trial.","armGroupLabels":["LY2189265 + Sulfonylureas (SU)"]},{"type":"DRUG","name":"Biguanides (BG)","description":"Biguanides is a pre-study prescribed dose and is not being provided as part of the trial.","armGroupLabels":["LY2189265 + Biguanides (BG)"]},{"type":"DRUG","name":"alpha-glucosidase inhibitor (a-GI)","description":"a-GI is a pre-study prescribed dose and is not being provided as part of the trial.","armGroupLabels":["LY2189265 + alpha-glucosidase inhibitor (a-GI)"]},{"type":"DRUG","name":"Thiazolidinedione (TZD)","description":"TZD is a pre-study prescribed dose and is not being provided as part of the trial.","armGroupLabels":["LY2189265 + Thiazolidinedione (TZD)"]},{"type":"DRUG","name":"Glinides","description":"Glinides is a pre-study prescribed dose and is not being provided as part of the trial.","armGroupLabels":["LY2189265 + Glinides"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)","description":"A TEAE was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.","timeFrame":"Baseline through 52 Weeks"},{"measure":"Percentage of Participants With Hypoglycemic Episodes","description":"The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least 1 hypoglycemic episode over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.","timeFrame":"Baseline through 52 Weeks"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Glycosylated Hemoglobin (HbA1c)","timeFrame":"Baseline, up to 26 Weeks and up to 52 Weeks"},{"measure":"Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%","timeFrame":"26 weeks and 52 weeks"},{"measure":"Change From Baseline in Fasting Blood Glucose (FBG)","timeFrame":"Baseline, up to 26 weeks and up to 52 weeks"},{"measure":"Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)","description":"Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal. For the mean of all 7-point blood glucose values, the daily mean was calculated as the average of 7 blood glucose values collected on a particular day. The mean of all 7-point blood glucose values at each visit was calculated as the average of 2 daily means. The change from baseline was calculated as the mean of all 7-point blood glucose values at endpoint minus the mean of all 7-point blood glucose values at baseline.","timeFrame":"Baseline, up to 26 weeks and up to 52 weeks"},{"measure":"Change From Baseline in Body Weight","timeFrame":"Baseline, up to 26 weeks and up to 52 weeks"},{"measure":"Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)","description":"The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).","timeFrame":"Baseline, up to 26 weeks and up to 52 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Participants who have had a diagnosis of type 2 diabetes mellitus before screening\n* Participants who have been taking SU (Glibenclamide, Gliclazide, Glimepiride), BG, TZD, a-GI or glinides monotherapy for at least 3 months before screening and have been on a stable dose for at least 8 weeks before screening\n* Participants must have a qualifying HbA1c value of 7.0% to 11.0% at screening\n* Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m\\^2)\n\nExclusion Criteria:\n\n* Participants who have a diagnosis of type 1 diabetes\n* Participants who have previously been treated with any other glucagon-like peptide-1 (GLP-1) analog within the 3 months before screening\n* Participants who are currently taking insulin or have had previous insulin treatment within the 3 months before screening\n* Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥3 times the upper limit of the reference range and/or a serum lipase concentration ≥2 times the upper limit of the reference range, as determined by the central laboratory at screening\n* Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC)","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT - 5, hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Aichi","zip":"466-0815","country":"Japan","geoPoint":{"lat":32.51879,"lon":130.62158}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Chiba","zip":"277-0825","country":"Japan","geoPoint":{"lat":35.6,"lon":140.11667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hokkaido","zip":"050-0073","country":"Japan"},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hyōgo","zip":"662-0971","country":"Japan","geoPoint":{"lat":43.36667,"lon":144.43333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Ibaraki","zip":"300-0053","country":"Japan","geoPoint":{"lat":34.81641,"lon":135.56828}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Kanagawa","zip":"231-0023","country":"Japan","geoPoint":{"lat":37.58333,"lon":139.91667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Kyoto","zip":"615-8125","country":"Japan","geoPoint":{"lat":35.02107,"lon":135.75385}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Nagano","zip":"390-1401","country":"Japan","geoPoint":{"lat":36.65,"lon":138.18333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Okayama","zip":"700-8558","country":"Japan","geoPoint":{"lat":34.65,"lon":133.93333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Osaka","zip":"560-0082","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Saitama","zip":"3438577","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Tokyo","zip":"1030002","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Toyama","zip":"930-0859","country":"Japan","geoPoint":{"lat":36.7,"lon":137.21667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Wakayama","zip":"644-0011","country":"Japan","geoPoint":{"lat":34.23333,"lon":135.16667}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"LY2189265 + Sulfonylureas (SU)","description":"LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."},{"id":"FG001","title":"LY2189265 + Biguanides (BG)","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."},{"id":"FG002","title":"LY2189265 + Alpha-glucosidas e Inhibitor (a-GI)","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."},{"id":"FG003","title":"LY2189265 + Thiazolidin Edione (TZD)","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."},{"id":"FG004","title":"LY2189265 + Glinides","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"131"},{"groupId":"FG001","numSubjects":"61"},{"groupId":"FG002","numSubjects":"65"},{"groupId":"FG003","numSubjects":"66"},{"groupId":"FG004","numSubjects":"71"}]},{"type":"Received at Least 1 Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"131"},{"groupId":"FG001","numSubjects":"61"},{"groupId":"FG002","numSubjects":"65"},{"groupId":"FG003","numSubjects":"66"},{"groupId":"FG004","numSubjects":"71"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"121"},{"groupId":"FG001","numSubjects":"59"},{"groupId":"FG002","numSubjects":"57"},{"groupId":"FG003","numSubjects":"63"},{"groupId":"FG004","numSubjects":"66"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"5"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All enrolled participants","groups":[{"id":"BG000","title":"LY2189265 + SU","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."},{"id":"BG001","title":"LY2189265 + BG","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."},{"id":"BG002","title":"LY2189265 + a-GI","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."},{"id":"BG003","title":"LY2189265 + TZD","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."},{"id":"BG004","title":"LY2189265 + Glinides","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."},{"id":"BG005","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"131"},{"groupId":"BG001","value":"61"},{"groupId":"BG002","value":"65"},{"groupId":"BG003","value":"66"},{"groupId":"BG004","value":"71"},{"groupId":"BG005","value":"394"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58.68","spread":"11.59"},{"groupId":"BG001","value":"52.69","spread":"10.19"},{"groupId":"BG002","value":"59.13","spread":"10.51"},{"groupId":"BG003","value":"56.40","spread":"10.51"},{"groupId":"BG004","value":"58.17","spread":"10.30"},{"groupId":"BG005","value":"57.35","spread":"10.96"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"36"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"14"},{"groupId":"BG004","value":"17"},{"groupId":"BG005","value":"98"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"95"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"55"},{"groupId":"BG003","value":"52"},{"groupId":"BG004","value":"54"},{"groupId":"BG005","value":"296"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"131"},{"groupId":"BG001","value":"61"},{"groupId":"BG002","value":"65"},{"groupId":"BG003","value":"66"},{"groupId":"BG004","value":"71"},{"groupId":"BG005","value":"394"}]},{"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"},{"groupId":"BG005","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Japan","categories":[{"measurements":[{"groupId":"BG000","value":"131"},{"groupId":"BG001","value":"61"},{"groupId":"BG002","value":"65"},{"groupId":"BG003","value":"66"},{"groupId":"BG004","value":"71"},{"groupId":"BG005","value":"394"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)","description":"A TEAE was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.","populationDescription":"All enrolled participants who received at least 1 dose of study drug","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline through 52 Weeks","groups":[{"id":"OG000","title":"LY2189265 + SU","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."},{"id":"OG001","title":"LY2189265 + BG","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."},{"id":"OG002","title":"LY2189265 + a-GI","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."},{"id":"OG003","title":"LY2189265 + TZD","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."},{"id":"OG004","title":"LY2189265 + Glinides","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"66"},{"groupId":"OG004","value":"71"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"85.5"},{"groupId":"OG001","value":"83.6"},{"groupId":"OG002","value":"70.8"},{"groupId":"OG003","value":"80.3"},{"groupId":"OG004","value":"73.2"}]}]}]},{"type":"PRIMARY","title":"Percentage of Participants With Hypoglycemic Episodes","description":"The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least 1 hypoglycemic episode over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.","populationDescription":"All enrolled participants who received at least 1 dose of study drug","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline through 52 Weeks","groups":[{"id":"OG000","title":"LY2189265 + SU","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."},{"id":"OG001","title":"LY2189265 + BG","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."},{"id":"OG002","title":"LY2189265 + a-GI","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."},{"id":"OG003","title":"LY2189265 + TZD","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."},{"id":"OG004","title":"LY2189265 + Glinides","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"66"},{"groupId":"OG004","value":"71"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"33.6"},{"groupId":"OG001","value":"3.3"},{"groupId":"OG002","value":"6.2"},{"groupId":"OG003","value":"6.1"},{"groupId":"OG004","value":"9.9"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Glycosylated Hemoglobin (HbA1c)","populationDescription":"Participants who were randomized and received at least 1 dose of study drug with evaluable HbA1c data. Last observation carried forward (LOCF) was used to impute missing postbaseline values.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, up to 26 Weeks and up to 52 Weeks","groups":[{"id":"OG000","title":"LY2189265 + SU","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."},{"id":"OG001","title":"LY2189265 + BG","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."},{"id":"OG002","title":"LY2189265 + a-GI","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."},{"id":"OG003","title":"LY2189265 + TZD","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."},{"id":"OG004","title":"LY2189265 + Glinides","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"66"},{"groupId":"OG004","value":"71"}]}],"classes":[{"title":"26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-1.93","spread":"0.09"},{"groupId":"OG001","value":"-1.58","spread":"0.11"},{"groupId":"OG002","value":"-1.67","spread":"0.10"},{"groupId":"OG003","value":"-1.71","spread":"0.13"},{"groupId":"OG004","value":"-1.80","spread":"0.12"}]}]},{"title":"52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-1.67","spread":"0.09"},{"groupId":"OG001","value":"-1.57","spread":"0.11"},{"groupId":"OG002","value":"-1.65","spread":"0.11"},{"groupId":"OG003","value":"-1.69","spread":"0.13"},{"groupId":"OG004","value":"-1.65","spread":"0.13"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"HbA1c at 26 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-1.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.87","ciUpperLimit":"-1.67"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"HbA1c at 52 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-1.65","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.75","ciUpperLimit":"-1.55"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%","populationDescription":"Participants who were randomized and received at least 1 dose of study drug with evaluable HbA1c data. LOCF was used to impute missing postbaseline values.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"26 weeks and 52 weeks","groups":[{"id":"OG000","title":"LY2189265 + SU","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."},{"id":"OG001","title":"LY2189265 + BG","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."},{"id":"OG002","title":"LY2189265 + a-GI","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."},{"id":"OG003","title":"LY2189265 + TZD","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."},{"id":"OG004","title":"LY2189265 + Glinides","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"66"},{"groupId":"OG004","value":"71"}]}],"classes":[{"title":"HbA1c ≤6.5% at Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"35.1"},{"groupId":"OG001","value":"54.1"},{"groupId":"OG002","value":"72.3"},{"groupId":"OG003","value":"60.6"},{"groupId":"OG004","value":"53.5"}]}]},{"title":"HbA1c ≤6.5% at Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"31.3"},{"groupId":"OG001","value":"57.4"},{"groupId":"OG002","value":"70.8"},{"groupId":"OG003","value":"57.6"},{"groupId":"OG004","value":"47.9"}]}]},{"title":"HbA1c <7.0% at Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"61.8"},{"groupId":"OG001","value":"73.8"},{"groupId":"OG002","value":"81.5"},{"groupId":"OG003","value":"72.7"},{"groupId":"OG004","value":"69.0"}]}]},{"title":"HbA1c <7.0% at Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"48.9"},{"groupId":"OG001","value":"73.8"},{"groupId":"OG002","value":"83.1"},{"groupId":"OG003","value":"77.3"},{"groupId":"OG004","value":"62.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Blood Glucose (FBG)","populationDescription":"Participants who were randomized and received at least 1 dose of study drug with evaluable FBG data. LOCF was used to impute missing postbaseline values.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligrams/deciliters (mg/dL)","timeFrame":"Baseline, up to 26 weeks and up to 52 weeks","groups":[{"id":"OG000","title":"LY2189265 + SU","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."},{"id":"OG001","title":"LY2189265 + BG","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."},{"id":"OG002","title":"LY2189265 + a-GI","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."},{"id":"OG003","title":"LY2189265 + TZD","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."},{"id":"OG004","title":"LY2189265 + Glinides","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"66"},{"groupId":"OG004","value":"71"}]}],"classes":[{"title":"26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-46.8","spread":"4.2"},{"groupId":"OG001","value":"-37.9","spread":"4.0"},{"groupId":"OG002","value":"-46.8","spread":"4.7"},{"groupId":"OG003","value":"-42.1","spread":"4.5"},{"groupId":"OG004","value":"-42.7","spread":"3.9"}]}]},{"title":"52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-43.2","spread":"3.8"},{"groupId":"OG001","value":"-36.0","spread":"4.2"},{"groupId":"OG002","value":"-47.0","spread":"4.7"},{"groupId":"OG003","value":"-39.6","spread":"5.0"},{"groupId":"OG004","value":"-45.8","spread":"4.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"FBG at 26 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Median Difference (Final Values)","paramValue":"-43.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-47.8","ciUpperLimit":"-40.0"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"FBG at 52 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-42.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-46.4","ciUpperLimit":"-38.7"}]},{"type":"SECONDARY","title":"Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)","description":"Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal. For the mean of all 7-point blood glucose values, the daily mean was calculated as the average of 7 blood glucose values collected on a particular day. The mean of all 7-point blood glucose values at each visit was calculated as the average of 2 daily means. The change from baseline was calculated as the mean of all 7-point blood glucose values at endpoint minus the mean of all 7-point blood glucose values at baseline.","populationDescription":"Participants who were randomized and received at least 1 dose of study drug with evaluable SMBG data. LOCF was used to impute missing postbaseline. values.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline, up to 26 weeks and up to 52 weeks","groups":[{"id":"OG000","title":"LY2189265 + SU","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."},{"id":"OG001","title":"LY2189265 + BG","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."},{"id":"OG002","title":"LY2189265 + a-GI","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."},{"id":"OG003","title":"LY2189265 + TZD","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."},{"id":"OG004","title":"LY2189265 + Glinides","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"66"},{"groupId":"OG004","value":"71"}]}],"classes":[{"title":"Pre-morning mean at 26 Weeks (n=131,61,64,66,71)","categories":[{"measurements":[{"groupId":"OG000","value":"-44.70","spread":"4.57"},{"groupId":"OG001","value":"-34.60","spread":"3.88"},{"groupId":"OG002","value":"-45.97","spread":"4.99"},{"groupId":"OG003","value":"-35.40","spread":"3.85"},{"groupId":"OG004","value":"-48.26","spread":"4.33"}]}]},{"title":"Pre-morning mean at 52 Weeks (n=131,61,64,66,71)","categories":[{"measurements":[{"groupId":"OG000","value":"-42.93","spread":"3.89"},{"groupId":"OG001","value":"-37.19","spread":"3.83"},{"groupId":"OG002","value":"-45.69","spread":"5.05"},{"groupId":"OG003","value":"-39.83","spread":"4.24"},{"groupId":"OG004","value":"-46.45","spread":"4.30"}]}]},{"title":"2hr postmorning meal at 26Weeks(n=131,61,65,66,71)","categories":[{"measurements":[{"groupId":"OG000","value":"-69.66","spread":"5.69"},{"groupId":"OG001","value":"-64.23","spread":"6.35"},{"groupId":"OG002","value":"-73.43","spread":"6.70"},{"groupId":"OG003","value":"-65.73","spread":"5.94"},{"groupId":"OG004","value":"-67.99","spread":"7.24"}]}]},{"title":"2hr postmorning meal at 52Weeks(n=131,61,65,66,71)","categories":[{"measurements":[{"groupId":"OG000","value":"-58.50","spread":"5.63"},{"groupId":"OG001","value":"-63.81","spread":"7.22"},{"groupId":"OG002","value":"-73.62","spread":"7.27"},{"groupId":"OG003","value":"-67.51","spread":"6.49"},{"groupId":"OG004","value":"-73.78","spread":"7.95"}]}]},{"title":"Pre-midday meal at 26 Weeks (n=131,61,65,66,71)","categories":[{"measurements":[{"groupId":"OG000","value":"-49.95","spread":"4.85"},{"groupId":"OG001","value":"-26.26","spread":"4.93"},{"groupId":"OG002","value":"-54.75","spread":"6.24"},{"groupId":"OG003","value":"-51.80","spread":"6.68"},{"groupId":"OG004","value":"-54.51","spread":"5.79"}]}]},{"title":"Pre-midday meal at 52 Weeks (n=131,61,65,66,71)","categories":[{"measurements":[{"groupId":"OG000","value":"-43.90","spread":"5.15"},{"groupId":"OG001","value":"-33.34","spread":"5.12"},{"groupId":"OG002","value":"-55.96","spread":"6.42"},{"groupId":"OG003","value":"-50.21","spread":"7.04"},{"groupId":"OG004","value":"-56.07","spread":"5.60"}]}]},{"title":"2hr postmidday meal at 26 Weeks(n=131,60,65,66,71)","categories":[{"measurements":[{"groupId":"OG000","value":"-67.24","spread":"5.24"},{"groupId":"OG001","value":"-50.03","spread":"5.70"},{"groupId":"OG002","value":"-67.70","spread":"7.37"},{"groupId":"OG003","value":"-80.02","spread":"7.93"},{"groupId":"OG004","value":"-68.49","spread":"7.84"}]}]},{"title":"2hr postmidday meal at 52 Weeks(n=131,60,65,66,71)","categories":[{"measurements":[{"groupId":"OG000","value":"-57.27","spread":"5.44"},{"groupId":"OG001","value":"-52.70","spread":"5.26"},{"groupId":"OG002","value":"-63.47","spread":"7.12"},{"groupId":"OG003","value":"-81.64","spread":"8.68"},{"groupId":"OG004","value":"-65.46","spread":"7.23"}]}]},{"title":"Pre-evening meal at 26 Weeks (n=130,61,65,66,70)","categories":[{"measurements":[{"groupId":"OG000","value":"-44.57","spread":"5.63"},{"groupId":"OG001","value":"-25.66","spread":"5.28"},{"groupId":"OG002","value":"-57.82","spread":"6.83"},{"groupId":"OG003","value":"-43.22","spread":"7.53"},{"groupId":"OG004","value":"-46.85","spread":"5.88"}]}]},{"title":"Pre-evening meal at 52 Weeks (n=130,61,65,66,70)","categories":[{"measurements":[{"groupId":"OG000","value":"-43.90","spread":"5.39"},{"groupId":"OG001","value":"-25.34","spread":"5.55"},{"groupId":"OG002","value":"-54.66","spread":"7.35"},{"groupId":"OG003","value":"-42.15","spread":"7.44"},{"groupId":"OG004","value":"-51.64","spread":"6.10"}]}]},{"title":"2hr postevening meal at 26Weeks(n=128,61,65,66,69)","categories":[{"measurements":[{"groupId":"OG000","value":"-62.24","spread":"6.05"},{"groupId":"OG001","value":"-45.41","spread":"6.71"},{"groupId":"OG002","value":"-71.15","spread":"7.57"},{"groupId":"OG003","value":"-66.14","spread":"8.22"},{"groupId":"OG004","value":"-68.75","spread":"7.88"}]}]},{"title":"2hr postevening meal at 52Weeks(n=128,61,65,66,69)","categories":[{"measurements":[{"groupId":"OG000","value":"-58.98","spread":"5.71"},{"groupId":"OG001","value":"-48.61","spread":"6.45"},{"groupId":"OG002","value":"-63.82","spread":"7.00"},{"groupId":"OG003","value":"-69.30","spread":"8.60"},{"groupId":"OG004","value":"-64.22","spread":"7.07"}]}]},{"title":"Bedtime at 26 Weeks (n=128, 61, 65, 63, 67)","categories":[{"measurements":[{"groupId":"OG000","value":"-61.07","spread":"5.08"},{"groupId":"OG001","value":"-49.98","spread":"6.48"},{"groupId":"OG002","value":"-63.98","spread":"6.90"},{"groupId":"OG003","value":"-66.19","spread":"8.75"},{"groupId":"OG004","value":"-64.01","spread":"6.56"}]}]},{"title":"Bedtime at 52 Weeks (n=128, 61, 65, 63, 67)","categories":[{"measurements":[{"groupId":"OG000","value":"-54.07","spread":"5.24"},{"groupId":"OG001","value":"-52.70","spread":"6.45"},{"groupId":"OG002","value":"-66.74","spread":"7.31"},{"groupId":"OG003","value":"-68.42","spread":"9.05"},{"groupId":"OG004","value":"-64.41","spread":"6.21"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"Pre-morning meal at 26 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-42.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-46.55","ciUpperLimit":"-38.29"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"Pre-morning meal at 52 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-42.60","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-46.44","ciUpperLimit":"-38.76"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"2 hours post-morning meal at 26 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-68.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-74.18","ciUpperLimit":"-62.79"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"2 hours post-morning meal at 52 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-66.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-72.12","ciUpperLimit":"-60.04"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"Pre-midday meal at 26 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-48.21","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-53.32","ciUpperLimit":"-43.09"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"Pre-midday meal at 52 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-47.51","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-52.77","ciUpperLimit":"-42.24"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"2 hours post-midday meal at 26 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-67.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-73.02","ciUpperLimit":"-61.11"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"2 hours post-midday meal at 52 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-63.17","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-69.16","ciUpperLimit":"-57.18"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"Pre-evening meal at 26 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-44.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-49.67","ciUpperLimit":"-38.34"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"Pre-evening meal at 52 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-43.88","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-49.55","ciUpperLimit":"-38.21"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"2 hours post-evening meal at 26 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-62.91","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-69.32","ciUpperLimit":"-56.50"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"2 hours post-evening meal at 52 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-60.84","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-66.95","ciUpperLimit":"-54.74"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"Bedtime meal at 26 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-61.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-66.93","ciUpperLimit":"-55.37"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"Bedtime meal at 52 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-60.16","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-66.07","ciUpperLimit":"-54.25"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","populationDescription":"Participants who were randomized and received at least 1 dose of study drug with evaluable body weight data. LOCF was used to impute missing postbaseline values.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilograms (kg)","timeFrame":"Baseline, up to 26 weeks and up to 52 weeks","groups":[{"id":"OG000","title":"LY2189265 + SU","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."},{"id":"OG001","title":"LY2189265 + BG","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."},{"id":"OG002","title":"LY2189265 + a-GI","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."},{"id":"OG003","title":"LY2189265 + TZD","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."},{"id":"OG004","title":"LY2189265 + Glinides","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"66"},{"groupId":"OG004","value":"71"}]}],"classes":[{"title":"26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.02","spread":"0.22"},{"groupId":"OG001","value":"-0.74","spread":"0.39"},{"groupId":"OG002","value":"-1.22","spread":"0.33"},{"groupId":"OG003","value":"0.78","spread":"0.30"},{"groupId":"OG004","value":"0.19","spread":"0.25"}]}]},{"title":"52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.10","spread":"0.24"},{"groupId":"OG001","value":"-0.87","spread":"0.40"},{"groupId":"OG002","value":"-1.24","spread":"0.42"},{"groupId":"OG003","value":"1.02","spread":"0.35"},{"groupId":"OG004","value":"0.04","spread":"0.26"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"Body weight at 26 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.277","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-0.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.40","ciUpperLimit":"0.12"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"Body weight at 52 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.382","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-0.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.42","ciUpperLimit":"0.16"}]},{"type":"SECONDARY","title":"Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)","description":"The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).","populationDescription":"Participants who were randomized and received at least 1 dose of study drug with evaluable HOMA2 data. LOCF was used to impute missing postbaseline values.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HOMA2","timeFrame":"Baseline, up to 26 weeks and up to 52 weeks","groups":[{"id":"OG000","title":"LY2189265 + SU","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."},{"id":"OG001","title":"LY2189265 + BG","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."},{"id":"OG002","title":"LY2189265 + a-GI","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."},{"id":"OG003","title":"LY2189265 + TZD","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."},{"id":"OG004","title":"LY2189265 + Glinides","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"127"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"59"},{"groupId":"OG004","value":"64"}]}],"classes":[{"title":"HOMA2-%B, 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"29.10","spread":"2.75"},{"groupId":"OG001","value":"28.15","spread":"2.79"},{"groupId":"OG002","value":"30.88","spread":"3.25"},{"groupId":"OG003","value":"27.34","spread":"2.60"},{"groupId":"OG004","value":"26.93","spread":"2.59"}]}]},{"title":"HOMA2-%B, 52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"26.06","spread":"2.77"},{"groupId":"OG001","value":"26.05","spread":"2.97"},{"groupId":"OG002","value":"28.06","spread":"3.61"},{"groupId":"OG003","value":"25.38","spread":"2.53"},{"groupId":"OG004","value":"33.51","spread":"3.81"}]}]},{"title":"HOMA2-%S, 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-4.80","spread":"3.40"},{"groupId":"OG001","value":"-3.48","spread":"4.39"},{"groupId":"OG002","value":"7.57","spread":"5.60"},{"groupId":"OG003","value":"-5.50","spread":"5.21"},{"groupId":"OG004","value":"-4.41","spread":"4.05"}]}]},{"title":"HOMA2-%S, 52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-3.99","spread":"3.18"},{"groupId":"OG001","value":"-3.83","spread":"4.89"},{"groupId":"OG002","value":"6.86","spread":"5.24"},{"groupId":"OG003","value":"0.47","spread":"5.87"},{"groupId":"OG004","value":"-5.51","spread":"4.71"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"HOMA2-B% at 26 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"28.59","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"26.00","ciUpperLimit":"31.18"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"HOMA2-B% at 52 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"27.57","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"24.73","ciUpperLimit":"30.41"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"HOMA2-S% at 26 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.194","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-2.57","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.46","ciUpperLimit":"1.32"},{"groupIds":["OG000","OG001","OG002","OG003","OG004"],"groupDescription":"HOMA2-S% at 52 Weeks","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.400","statisticalMethod":"t-test, 2 sided","statisticalComment":"p-values are from within-group change t-test at the level of 0.05","paramType":"Mean Difference (Final Values)","paramValue":"-1.70","ciPctValue":"65","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.68","ciUpperLimit":"2.27"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"LY2189265 + SU","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.","seriousNumAffected":9,"seriousNumAtRisk":131,"otherNumAffected":112,"otherNumAtRisk":131},{"id":"EG001","title":"LY2189265 + BG","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.","seriousNumAffected":3,"seriousNumAtRisk":61,"otherNumAffected":51,"otherNumAtRisk":61},{"id":"EG002","title":"LY2189265 + a-GI","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.","seriousNumAffected":4,"seriousNumAtRisk":65,"otherNumAffected":46,"otherNumAtRisk":65},{"id":"EG003","title":"LY2189265 + TZD","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.","seriousNumAffected":1,"seriousNumAtRisk":66,"otherNumAffected":53,"otherNumAtRisk":66},{"id":"EG004","title":"LY2189265 + Glinides","description":"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks\n\nParticipants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.","seriousNumAffected":3,"seriousNumAtRisk":71,"otherNumAffected":52,"otherNumAtRisk":71}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Coronary artery stenosis","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Myocardial ischaemia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Large intestine polyp","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Pancreatic enzyme abnormality","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Oedema","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Bile duct stone","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Cholangitis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Ankle fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Concussion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Pelvic fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Adenocarcinoma gastric","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Benign soft tissue neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Bile duct cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Gastric cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Ovarian neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":36},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":21},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":17}]},{"term":"Rectal cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Prostatitis","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":95},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":40},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":55},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":52},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":54}]},{"term":"Pleurisy","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]}],"otherEvents":[{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Polycythaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Arrhythmia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":2,"numAffected":1,"numAtRisk":71}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Cardiac failure congestive","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Palpitations","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":2,"numAffected":1,"numAtRisk":71}]},{"term":"Tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Deafness neurosensory","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Ear pruritus","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Basedow's disease","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Hypothyroidism","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Asthenopia","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Blepharitis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Cataract","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Conjunctival haemorrhage","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Conjunctivitis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Conjunctivitis allergic","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Diabetic retinopathy","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Dry eye","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Glaucoma","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Iritis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Macular oedema","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Optic ischaemic neuropathy","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Photophobia","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Retinal haemorrhage","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Vitreous floaters","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Abdominal discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":65},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":4,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":65},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":66},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":71}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Abdominal tenderness","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Acute abdomen","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Cheilitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":22,"numAffected":20,"numAtRisk":131},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":61},{"groupId":"EG002","numEvents":8,"numAffected":8,"numAtRisk":65},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":66},{"groupId":"EG004","numEvents":6,"numAffected":5,"numAtRisk":71}]},{"term":"Dental caries","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":71}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":14,"numAffected":13,"numAtRisk":131},{"groupId":"EG001","numEvents":13,"numAffected":9,"numAtRisk":61},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":65},{"groupId":"EG003","numEvents":8,"numAffected":5,"numAtRisk":66},{"groupId":"EG004","numEvents":9,"numAffected":7,"numAtRisk":71}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":18,"numAffected":6,"numAtRisk":131},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":61},{"groupId":"EG002","numEvents":2,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":8,"numAffected":5,"numAtRisk":71}]},{"term":"Eructation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Faeces hard","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Flatulence","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Gastric polyps","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Gastric ulcer","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Gastritis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":131},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":61},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":65},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":66},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":71}]},{"term":"Gastritis atrophic","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Gastrointestinal hypomotility","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Gastrooesophageal reflux disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":4,"numAffected":3,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":71}]},{"term":"Gingival pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Haemorrhoids","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Large intestine polyp","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":82,"numAffected":17,"numAtRisk":131},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":61},{"groupId":"EG002","numEvents":8,"numAffected":4,"numAtRisk":65},{"groupId":"EG003","numEvents":6,"numAffected":5,"numAtRisk":66},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":71}]},{"term":"Pancreatic enzyme abnormality","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Pancreatitis acute","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Periodontal disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Retching","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Stomatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":8,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":65},{"groupId":"EG003","numEvents":5,"numAffected":3,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Chest discomfort","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Facial pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Feeling abnormal","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Injection site bruising","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Injection site discomfort","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Injection site eczema","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Injection site erythema","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Injection site haemorrhage","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Injection site induration","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Injection site pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":2,"numAffected":1,"numAtRisk":71}]},{"term":"Injection site pruritus","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":65},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":66},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":71}]},{"term":"Injection site reaction","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Injection site swelling","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Local swelling","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Malaise","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Oedema","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Oedema peripheral","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Pyrexia","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Xerosis","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Biliary colic","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Gallbladder polyp","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Hepatic cyst","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Hepatic steatosis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Hepatitis alcoholic","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Seasonal allergy","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Adenoiditis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Bronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":14,"numAffected":10,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":4,"numAffected":2,"numAtRisk":66},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":71}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Chronic sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Cystitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Eczema infected","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Enteritis infectious","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":4,"numAffected":2,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Folliculitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Furuncle","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":131},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Gastroenteritis viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Genital herpes","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Gingivitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Helicobacter infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Herpes virus infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Herpes zoster","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":131},{"groupId":"EG001","numEvents":7,"numAffected":7,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":71}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":51,"numAffected":31,"numAtRisk":131},{"groupId":"EG001","numEvents":25,"numAffected":16,"numAtRisk":61},{"groupId":"EG002","numEvents":15,"numAffected":11,"numAtRisk":65},{"groupId":"EG003","numEvents":26,"numAffected":16,"numAtRisk":66},{"groupId":"EG004","numEvents":18,"numAffected":16,"numAtRisk":71}]},{"term":"Oral herpes","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Paronychia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Periodontitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Pharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":7,"numAtRisk":131},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":61},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":65},{"groupId":"EG003","numEvents":6,"numAffected":6,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Pulpitis dental","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Skin infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Tinea pedis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":71}]},{"term":"Tonsillitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Urinary tract infection bacterial","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Viral infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Arthropod bite","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Contusion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":66},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":71}]},{"term":"Excoriation","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Fall","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Foot fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Hand fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Head injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Heat stroke","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Laceration","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Ligament sprain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Limb injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Lip injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Muscle strain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Post procedural haemorrhage","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Post-traumatic neck syndrome","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Radius fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Thermal burn","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Tooth fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Tooth injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Alanine aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Amylase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":65},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":66},{"groupId":"EG004","numEvents":2,"numAffected":1,"numAtRisk":71}]},{"term":"Aspartate aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Blood creatine phosphokinase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Blood pressure decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Blood pressure diastolic increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Blood pressure increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Blood urea increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Blood uric acid increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Gamma-glutamyltransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Lipase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":11,"numAtRisk":131},{"groupId":"EG001","numEvents":6,"numAffected":6,"numAtRisk":61},{"groupId":"EG002","numEvents":7,"numAffected":6,"numAtRisk":65},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":66},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":71}]},{"term":"Pancreatic enzymes increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Weight decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Weight increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":16,"numAffected":10,"numAtRisk":131},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":61},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":71}]},{"term":"Dyslipidaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Gout","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":71}]},{"term":"Hyperlipidaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Hyperuricaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Arthralgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":71}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":8,"numAtRisk":131},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":61},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":65},{"groupId":"EG003","numEvents":7,"numAffected":6,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Cervical spinal stenosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Flank pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Intervertebral disc protrusion","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Knee deformity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Muscle spasms","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":131},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Musculoskeletal stiffness","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Myalgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Nodal osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Pain in extremity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":65},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Periarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Spinal column stenosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Spinal osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Tenosynovitis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Trigger finger","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Skin papilloma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Soft tissue neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Carotid arteriosclerosis","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Cervicobrachial syndrome","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Diabetic neuropathy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":4,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":2,"numAffected":1,"numAtRisk":71}]},{"term":"Hypoaesthesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Intracranial aneurysm","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Lacunar infarction","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Migraine","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Neuralgia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Sciatica","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Somnolence","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":17,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Tremor","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":3,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Trigeminal neuralgia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Visual field defect","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Decreased interest","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Calculus ureteric","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Cystitis haemorrhagic","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Diabetic nephropathy","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Dysuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Haematuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Nephrolithiasis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Pollakiuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Renal cyst","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Amenorrhoea","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":36},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":21},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":17}]},{"term":"Erectile dysfunction","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":95},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":40},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":55},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":52},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":54}]},{"term":"Prostatitis","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":95},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":40},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":55},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":52},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":54}]},{"term":"Pruritus genital","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Varicocele","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Cough","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":71}]},{"term":"Emphysema","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Epistaxis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Oropharyngeal pain","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Rhinitis allergic","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Sleep apnoea syndrome","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Upper respiratory tract inflammation","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Acne","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Cold urticaria","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Dermal cyst","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Dermatitis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Dermatitis contact","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Dry skin","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Eczema","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":3,"numAffected":2,"numAtRisk":71}]},{"term":"Ingrowing nail","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Leukoplakia","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Miliaria","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Onychalgia","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Palmoplantar keratoderma","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Perivascular dermatitis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Pruritus","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":3,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":2,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Psoriasis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Purpura","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Rash","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":2,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Swelling face","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Urticaria","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Xeroderma","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Bladder catheterisation","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Cataract operation","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Colon polypectomy","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Coronary angioplasty","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Coronary artery bypass","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Dental care","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Duodenal sphincterotomy","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Open reduction of fracture","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":71}]},{"term":"Percutaneous coronary intervention","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Photocoagulation","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Skin lesion excision","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Tooth extraction","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":66},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":71}]},{"term":"Arteriosclerosis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Flushing","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":131},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":61},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":65},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":66},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":71}]},{"term":"Peripheral coldness","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":131},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":71}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"GT60","restrictiveAgreement":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","phone":"800-545-5979"}}},"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":"C555680","term":"dulaglutide"},{"id":"D013453","term":"Sulfonylurea Compounds"},{"id":"D001645","term":"Biguanides"},{"id":"D065089","term":"Glycoside Hydrolase Inhibitors"},{"id":"C089946","term":"2,4-thiazolidinedione"}],"ancestors":[{"id":"D014508","term":"Urea"},{"id":"D000577","term":"Amides"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D013450","term":"Sulfones"},{"id":"D013457","term":"Sulfur Compounds"},{"id":"D006146","term":"Guanidines"},{"id":"D000578","term":"Amidines"},{"id":"D004791","term":"Enzyme Inhibitors"},{"id":"D045504","term":"Molecular Mechanisms of Pharmacological Action"},{"id":"D020228","term":"Pharmacologic Actions"},{"id":"D020164","term":"Chemical Actions and Uses"},{"id":"D007004","term":"Hypoglycemic Agents"},{"id":"D045505","term":"Physiological Effects of Drugs"}]}},"hasResults":true}