{"protocolSection":{"identificationModule":{"nctId":"NCT00839527","orgStudyIdInfo":{"id":"112757"},"organization":{"fullName":"GlaxoSmithKline","class":"INDUSTRY"},"briefTitle":"A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes","officialTitle":"A Randomized, Double-blind, Placebo and Active-Controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone in Subjects With Type 2 Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2016-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-02"},"primaryCompletionDateStruct":{"date":"2012-01","type":"ACTUAL"},"completionDateStruct":{"date":"2013-04","type":"ACTUAL"},"studyFirstSubmitDate":"2009-02-05","studyFirstSubmitQcDate":"2009-02-05","studyFirstPostDateStruct":{"date":"2009-02-09","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-04-24","resultsFirstSubmitQcDate":"2014-05-29","resultsFirstPostDateStruct":{"date":"2014-07-01","type":"ESTIMATED"},"dispFirstSubmitDate":"2012-04-03","dispFirstSubmitQcDate":"2012-04-03","dispFirstPostDateStruct":{"date":"2012-04-05","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-11-18","lastUpdatePostDateStruct":{"date":"2017-01-09","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"GlaxoSmithKline","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes"},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"],"keywords":["diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":685,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"metformin + glimepiride + pioglitazone + albiglutide placebo","type":"ACTIVE_COMPARATOR","description":"Metformin + glimepiride + pioglitazone + matching albiglutide placebo","interventionNames":["Drug: placebo to match albiglutide","Drug: metformin","Drug: glimepiride","Drug: pioglitazone"]},{"label":"metformin + glimepiride + pioglitazone placebo + albiglutide","type":"EXPERIMENTAL","description":"Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide","interventionNames":["Biological: albiglutide","Drug: metformin","Drug: glimepiride","Drug: placebo to match pioglitazone"]},{"label":"met + glimepiride + pioglitazone placebo + albiglutide placebo","type":"ACTIVE_COMPARATOR","description":"metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo","interventionNames":["Drug: placebo to match albiglutide","Drug: metformin","Drug: glimepiride","Drug: placebo to match pioglitazone"]}],"interventions":[{"type":"DRUG","name":"placebo to match albiglutide","description":"albiglutide matching placebo weekly subcutaneous injection","armGroupLabels":["met + glimepiride + pioglitazone placebo + albiglutide placebo","metformin + glimepiride + pioglitazone + albiglutide placebo"]},{"type":"BIOLOGICAL","name":"albiglutide","description":"albiglutide weekly subcutaneous injection","armGroupLabels":["metformin + glimepiride + pioglitazone placebo + albiglutide"]},{"type":"DRUG","name":"metformin","description":"metformin","armGroupLabels":["met + glimepiride + pioglitazone placebo + albiglutide placebo","metformin + glimepiride + pioglitazone + albiglutide placebo","metformin + glimepiride + pioglitazone placebo + albiglutide"]},{"type":"DRUG","name":"glimepiride","description":"glimepiride","armGroupLabels":["met + glimepiride + pioglitazone placebo + albiglutide placebo","metformin + glimepiride + pioglitazone + albiglutide placebo","metformin + glimepiride + pioglitazone placebo + albiglutide"]},{"type":"DRUG","name":"pioglitazone","description":"pioglitazone","armGroupLabels":["metformin + glimepiride + pioglitazone + albiglutide placebo"]},{"type":"DRUG","name":"placebo to match pioglitazone","description":"pioglitazone matching placebo","armGroupLabels":["met + glimepiride + pioglitazone placebo + albiglutide placebo","metformin + glimepiride + pioglitazone placebo + albiglutide"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. Nine par. with post-BL values obtained \\>14 days after the last dose or after hyperglycemic rescue were included in the analysis population but were not analyzed for this endpoint.","timeFrame":"Baseline and Week 52"}],"secondaryOutcomes":[{"measure":"Change From Baseline in HbA1c at Week 104 and Week 156","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","timeFrame":"Baseline, Week 104, and Week 156"},{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52","description":"The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.","timeFrame":"Baseline and Week 52"},{"measure":"Change From Baseline in FPG at Week 104 and Week 156","description":"The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","timeFrame":"Baseline, Week 104, and Week 156"},{"measure":"Time to Hyperglycemia Rescue","description":"Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG \\>=280 milligrams/deciliter (mg/dL) between \\>=Week 2 and \\=250 mg/dL between \\>=Week 4 and \\=8.5% and a \\<=0.5% reduction from Baseline between \\>=Week 12 and \\=8.5% between \\>=Week 24 and \\=8.0% between \\>= Week 48 and \\=1 treatment dose.","groups":[{"id":"FG000","title":"Placebo + Metformin + Glimepiride","description":"Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams \\[mg\\] daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"FG001","title":"Pioglitazone + Metformin + Glimepiride","description":"Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"FG002","title":"Albiglutide + Metformin + Glimepiride","description":"Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."}],"periods":[{"title":"Treatment Period (TP) (156 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"115"},{"groupId":"FG001","numSubjects":"277"},{"groupId":"FG002","numSubjects":"271"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"55"},{"groupId":"FG001","numSubjects":"159"},{"groupId":"FG002","numSubjects":"152"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"60"},{"groupId":"FG001","numSubjects":"118"},{"groupId":"FG002","numSubjects":"119"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"29"},{"groupId":"FG002","numSubjects":"22"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Noncompliance","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"16"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"7"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"46"},{"groupId":"FG002","numSubjects":"64"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Termination of Site by Sponsor","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"5"}]},{"type":"Missing","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Persistant Elevated HbA1c Results","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Site Closed","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Sponsor Decision on Blinding","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]}]},{"title":"Follow-up Period (FUP) (8 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"Par. withdrawing from the TP could enter the FUP. One par. did not participate in the FUP.","numSubjects":"114"},{"groupId":"FG001","comment":"Par. withdrawing from the TP could enter the FUP. Four par. did not participate in the FUP.","numSubjects":"273"},{"groupId":"FG002","comment":"Par. withdrawing from the TP could enter the FUP. Five par. did not participate in the FUP.","numSubjects":"266"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"86"},{"groupId":"FG001","numSubjects":"217"},{"groupId":"FG002","numSubjects":"204"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"56"},{"groupId":"FG002","numSubjects":"62"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Noncompliance","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"5"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"29"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"19"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Termination of Study by Sponsor","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"5"}]},{"type":"Informed Consent Recalled by Participant","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Investigator Closed Study at Site","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Site Closed","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Site Closing and Withdrew Consent","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Unable to Complete Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Missing Follow-up Status","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo + Metformin + Glimepiride","description":"Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams \\[mg\\] daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"BG001","title":"Pioglitazone + Metformin + Glimepiride","description":"Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"BG002","title":"Albiglutide + Metformin + Glimepiride","description":"Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"115"},{"groupId":"BG001","value":"277"},{"groupId":"BG002","value":"271"},{"groupId":"BG003","value":"663"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"55.7","spread":"9.59"},{"groupId":"BG001","value":"55.7","spread":"9.39"},{"groupId":"BG002","value":"54.5","spread":"9.47"},{"groupId":"BG003","value":"55.2","spread":"9.46"}]}]}]},{"title":"Gender","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"129"},{"groupId":"BG002","value":"136"},{"groupId":"BG003","value":"310"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"70"},{"groupId":"BG001","value":"148"},{"groupId":"BG002","value":"135"},{"groupId":"BG003","value":"353"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"African American/African Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"34"},{"groupId":"BG003","value":"68"}]}]},{"title":"American Indian or Alaskan Native","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"22"},{"groupId":"BG003","value":"41"}]}]},{"title":"Asian - Central/South Asian Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"20"}]}]},{"title":"Asian - East Asian Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"22"}]}]},{"title":"Asian - Japanese Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"3"}]}]},{"title":"Asian - South East Asian Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"14"},{"groupId":"BG003","value":"45"}]}]},{"title":"Native Hawaiian or Other Pacific Islander","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}]}]},{"title":"White - Arabic/North African Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"5"}]}]},{"title":"White - White/Caucasian/European Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"79"},{"groupId":"BG001","value":"201"},{"groupId":"BG002","value":"176"},{"groupId":"BG003","value":"456"}]}]},{"title":"Mexican American","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. Nine par. with post-BL values obtained \\>14 days after the last dose or after hyperglycemic rescue were included in the analysis population but were not analyzed for this endpoint.","populationDescription":"Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received \\>=1 dose of study medication and who had a BL assessment and \\>=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of HbA1c in the blood","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Placebo + Metformin + Glimepiride","description":"Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams \\[mg\\] daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Pioglitazone + Metformin + Glimepiride","description":"Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG002","title":"Albiglutide + Metformin + Glimepiride","description":"Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"268"},{"groupId":"OG002","value":"265"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.33","spread":"0.083"},{"groupId":"OG001","value":"-0.80","spread":"0.055"},{"groupId":"OG002","value":"-0.55","spread":"0.055"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-0.87","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.07","ciUpperLimit":"-0.68"},{"groupIds":["OG001","OG002"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"The p-value is from a one-sided t-test testing at the 0.025 level of significance whether or not the difference of least square means (albiglutide - pioglitazone) is less than or equal to the pre-specified non-inferiority margin of 0.3%.","pValue":"0.2685","statisticalMethod":"t-test, 1 sided","paramType":"Mean Difference (Net)","paramValue":"0.25","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.10","ciUpperLimit":"0.40"}]},{"type":"SECONDARY","title":"Change From Baseline in HbA1c at Week 104 and Week 156","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","populationDescription":"ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c in the blood","timeFrame":"Baseline, Week 104, and Week 156","groups":[{"id":"OG000","title":"Placebo + Metformin + Glimepiride","description":"Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams \\[mg\\] daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Pioglitazone + Metformin + Glimepiride","description":"Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG002","title":"Albiglutide + Metformin + Glimepiride","description":"Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"104"}]}],"classes":[{"title":"Week 104, n=12, 130, 104","categories":[{"measurements":[{"groupId":"OG000","value":"-0.32","spread":"0.552"},{"groupId":"OG001","value":"-1.09","spread":"1.119"},{"groupId":"OG002","value":"-0.76","spread":"1.009"}]}]},{"title":"Week 156, n=9, 89, 71","categories":[{"measurements":[{"groupId":"OG000","value":"-0.10","spread":"0.923"},{"groupId":"OG001","value":"-0.97","spread":"1.063"},{"groupId":"OG002","value":"-0.46","spread":"1.113"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52","description":"The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.","populationDescription":"Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Millimoles per liter (mmol/L)","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Placebo + Metformin + Glimepiride","description":"Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams \\[mg\\] daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Pioglitazone + Metformin + Glimepiride","description":"Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG002","title":"Albiglutide + Metformin + Glimepiride","description":"Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"268"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.64","spread":"0.243"},{"groupId":"OG001","value":"-1.74","spread":"0.158"},{"groupId":"OG002","value":"-0.69","spread":"0.159"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in FPG at Week 104 and Week 156","description":"The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","populationDescription":"ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimoles per liter (mmol/L)","timeFrame":"Baseline, Week 104, and Week 156","groups":[{"id":"OG000","title":"Placebo + Metformin + Glimepiride","description":"Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams \\[mg\\] daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Pioglitazone + Metformin + Glimepiride","description":"Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG002","title":"Albiglutide + Metformin + Glimepiride","description":"Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"128"},{"groupId":"OG002","value":"103"}]}],"classes":[{"title":"Week 104, n=12, 128, 103","categories":[{"measurements":[{"groupId":"OG000","value":"0.43","spread":"3.346"},{"groupId":"OG001","value":"-1.98","spread":"3.471"},{"groupId":"OG002","value":"-0.99","spread":"3.083"}]}]},{"title":"Week 156, n=9, 88, 71","categories":[{"measurements":[{"groupId":"OG000","value":"-0.50","spread":"4.093"},{"groupId":"OG001","value":"-1.94","spread":"3.127"},{"groupId":"OG002","value":"-0.88","spread":"2.652"}]}]}]},{"type":"SECONDARY","title":"Time to Hyperglycemia Rescue","description":"Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG \\>=280 milligrams/deciliter (mg/dL) between \\>=Week 2 and \\=250 mg/dL between \\>=Week 4 and \\=8.5% and a \\<=0.5% reduction from Baseline between \\>=Week 12 and \\=8.5% between \\>=Week 24 and \\=8.0% between \\>= Week 48 and \\=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Pioglitazone + Metformin + Glimepiride","description":"Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG002","title":"Albiglutide + Metformin + Glimepiride","description":"Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"273"},{"groupId":"OG002","value":"269"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"49.57","lowerLimit":"38.86","upperLimit":"55.14"},{"groupId":"OG001","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"There were too few events of hyperglycemia rescue (\\<50% of participants with events) to calculate the median and confidence interval."},{"groupId":"OG002","value":"137.71","lowerLimit":"93.71","upperLimit":"NA","comment":"The upper bound of the 95% confidence interval is not available because it is beyond the study duration."}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52","description":"The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of \\<6.5%, \\<7%, and \\<7.5% at Week 52) was assessed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.","populationDescription":"ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Placebo + Metformin + Glimepiride","description":"Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams \\[mg\\] daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Pioglitazone + Metformin + Glimepiride","description":"Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG002","title":"Albiglutide + Metformin + Glimepiride","description":"Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"268"},{"groupId":"OG002","value":"265"}]}],"classes":[{"title":"HbA1c <6.5%","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"27"}]}]},{"title":"HbA1c <7.0%","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"94"},{"groupId":"OG002","value":"79"}]}]},{"title":"HbA1c <7.5%","categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"150"},{"groupId":"OG002","value":"126"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156","description":"The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of \\<6.5%, \\<7%, and \\<7.5% at Week 156) was assessed.","populationDescription":"ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 156","groups":[{"id":"OG000","title":"Placebo + Metformin + Glimepiride","description":"Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams \\[mg\\] daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Pioglitazone + Metformin + Glimepiride","description":"Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG002","title":"Albiglutide + Metformin + Glimepiride","description":"Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"89"},{"groupId":"OG002","value":"71"}]}],"classes":[{"title":"HbA1c <6.5%","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"16"}]}]},{"title":"HbA1c <7.0%","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"44"},{"groupId":"OG002","value":"26"}]}]},{"title":"HbA1c <7.5%","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"45"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight at Week 52","description":"The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.","populationDescription":"ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Kilograms","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Placebo + Metformin + Glimepiride","description":"Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams \\[mg\\] daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Pioglitazone + Metformin + Glimepiride","description":"Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG002","title":"Albiglutide + Metformin + Glimepiride","description":"Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"268"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.40","spread":"0.362"},{"groupId":"OG001","value":"4.43","spread":"0.235"},{"groupId":"OG002","value":"-0.42","spread":"0.237"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight at Week 104 and Week 156","description":"The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","populationDescription":"ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms","timeFrame":"Baseline, Week 104, and Week 156","groups":[{"id":"OG000","title":"Placebo + Metformin + Glimepiride","description":"Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams \\[mg\\] daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG001","title":"Pioglitazone + Metformin + Glimepiride","description":"Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."},{"id":"OG002","title":"Albiglutide + Metformin + Glimepiride","description":"Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"104"}]}],"classes":[{"title":"Week 104, n=12, 130, 104","categories":[{"measurements":[{"groupId":"OG000","value":"-2.16","spread":"3.603"},{"groupId":"OG001","value":"6.28","spread":"6.189"},{"groupId":"OG002","value":"-0.90","spread":"3.721"}]}]},{"title":"Week 156, n=9, 90, 71","categories":[{"measurements":[{"groupId":"OG000","value":"-4.47","spread":"5.380"},{"groupId":"OG001","value":"6.52","spread":"6.332"},{"groupId":"OG002","value":"-1.53","spread":"3.880"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"2","timeFrame":"On-treatment serious adverse events (SAEs) and non-serious AEs, defined as those events that had a start date on or after the first day of study medication and within 56 days after the end of study medication (up to Week 156), are reported.","description":"SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.","eventGroups":[{"id":"EG000","title":"Placebo + Metformin + Glimepiride","description":"Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams \\[mg\\] daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.","seriousNumAffected":21,"seriousNumAtRisk":115,"otherNumAffected":81,"otherNumAtRisk":115},{"id":"EG001","title":"Pioglitazone + Metformin + Glimepiride","description":"Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.","seriousNumAffected":48,"seriousNumAtRisk":277,"otherNumAffected":228,"otherNumAtRisk":277},{"id":"EG002","title":"Albiglutide + Metformin + Glimepiride","description":"Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (\\>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.","seriousNumAffected":39,"seriousNumAtRisk":271,"otherNumAffected":228,"otherNumAtRisk":271}],"seriousEvents":[{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":115},{"groupId":"EG001","numAffected":4,"numAtRisk":277},{"groupId":"EG002","numAffected":3,"numAtRisk":271}]},{"term":"Cardiac failure congestive","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115},{"groupId":"EG001","numAffected":4,"numAtRisk":277},{"groupId":"EG002","numAffected":0,"numAtRisk":271}]},{"term":"Angina unstable","organSystem":"Cardiac 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infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":115},{"groupId":"EG001","numAffected":1,"numAtRisk":277},{"groupId":"EG002","numAffected":0,"numAtRisk":271}]},{"term":"Diabetic foot infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115},{"groupId":"EG001","numAffected":0,"numAtRisk":277},{"groupId":"EG002","numAffected":1,"numAtRisk":271}]},{"term":"Abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":115},{"groupId":"EG001","numAffected":1,"numAtRisk":277},{"groupId":"EG002","numAffected":0,"numAtRisk":271}]},{"term":"Febrile infection","organSystem":"Infections and 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infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115},{"groupId":"EG001","numAffected":0,"numAtRisk":277},{"groupId":"EG002","numAffected":0,"numAtRisk":271}]},{"term":"Infected bites","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":115},{"groupId":"EG001","numAffected":0,"numAtRisk":277},{"groupId":"EG002","numAffected":1,"numAtRisk":271}]},{"term":"Influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115},{"groupId":"EG001","numAffected":0,"numAtRisk":277},{"groupId":"EG002","numAffected":0,"numAtRisk":271}]},{"term":"Lobar pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115},{"groupId":"EG001","numAffected":0,"numAtRisk":277},{"groupId":"EG002","numAffected":0,"numAtRisk":271}]},{"term":"Localised infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":115},{"groupId":"EG001","numAffected":1,"numAtRisk":277},{"groupId":"EG002","numAffected":0,"numAtRisk":271}]},{"term":"Meningitis pneumococcal","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115},{"groupId":"EG001","numAffected":0,"numAtRisk":277},{"groupId":"EG002","numAffected":0,"numAtRisk":271}]},{"term":"Pancreatitis viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":115},{"groupId":"EG001","numAffected":0,"numAtRisk":277},{"groupId":"EG002","numAffected":1,"numAtRisk":271}]},{"term":"Peritonitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":115},{"groupId":"EG001","numAffected":1,"numAtRisk":277},{"groupId":"EG002","numAffected":0,"numAtRisk":271}]},{"term":"Postoperative wound infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":115},{"groupId":"EG001","numAffected":1,"numAtRisk":277},{"groupId":"EG002","numAffected":0,"numAtRisk":271}]},{"term":"Septic shock","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":115},{"groupId":"EG001","numAffected":1,"numAtRisk":277},{"groupId":"EG002","numAffected":0,"numAtRisk":271}]},{"term":"Tracheobronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":115},{"groupId":"EG001","numAffected":0,"numAtRisk":277},{"groupId":"EG002","numAffected":1,"numAtRisk":271}]},{"term":"Cerebrovascular accident","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115},{"groupId":"EG001","numAffected":3,"numAtRisk":277},{"groupId":"EG002","numAffected":0,"numAtRisk":271}]},{"term":"Carotid artery stenosis","organSystem":"Nervous system 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