{"protocolSection":{"identificationModule":{"nctId":"NCT00838916","orgStudyIdInfo":{"id":"112754"},"organization":{"fullName":"GlaxoSmithKline","class":"INDUSTRY"},"briefTitle":"A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes","officialTitle":"A Randomized, Open-label, Parallel-group, Multicenter Study to Determine the Efficacy and Long-term Safety of Albiglutide Compared With Insulin 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":"2013-05","type":"ACTUAL"},"studyFirstSubmitDate":"2009-02-05","studyFirstSubmitQcDate":"2009-02-05","studyFirstPostDateStruct":{"date":"2009-02-09","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-04-17","resultsFirstSubmitQcDate":"2014-05-22","resultsFirstPostDateStruct":{"date":"2014-06-04","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":"A study 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":"NONE"}},"enrollmentInfo":{"count":779,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"albiglutide weekly injection","type":"EXPERIMENTAL","description":"albiglutide weekly subcutaneous injection","interventionNames":["Biological: albiglutide"]},{"label":"insulin glargine","type":"ACTIVE_COMPARATOR","description":"insulin glargine daily injection","interventionNames":["Drug: insulin glargine"]}],"interventions":[{"type":"BIOLOGICAL","name":"albiglutide","description":"albiglutide weekly injection","armGroupLabels":["albiglutide weekly injection"]},{"type":"DRUG","name":"insulin glargine","description":"insulin glargine","armGroupLabels":["insulin glargine"]}]},"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 + current antidiabetic therapy. Difference of least squares means (albiglutide - insulin glargine) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline 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.","timeFrame":"Baseline and Week 52"}],"secondaryOutcomes":[{"measure":"Change From Baseline in HbA1c at 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. 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 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 + current antidiabetic therapy.","timeFrame":"Baseline and Week 52"},{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG) at 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.","timeFrame":"Baseline and Week 156"},{"measure":"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 achieved the HbA1c treatment goal (i.e., HbA1c response levels of \\<6.5%, \\<7%, and \\<7.5% at Week 52) were assessed.","timeFrame":"Week 52"},{"measure":"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 achieved the HbA1c treatment goal (i.e., HbA1c response levels of \\<6.5%, \\<7%, and \\<7.5% at Week 156) were assessed.","timeFrame":"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 \\<Week 4; FPG \\>=250 mg/dL between \\>=Week 4 and \\<Week 12; HbA1c \\>=8.5% and a \\<=0.5% reduction from Baseline between \\>=Week 12 and \\<Week 24; HbA1c \\>=8.5% between \\>=Week 24 and \\<Week 48; HbA1c \\>=8.0% between \\>= Week 48 and \\<Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.","timeFrame":"From the start of study medication until the end of the treatment (up to Week 156)"},{"measure":"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 prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.","timeFrame":"Baseline and Week 52"},{"measure":"Change From Baseline in Body Weight at 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.","timeFrame":"Baseline and Week 156"},{"measure":"Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52","description":"A 24-hour glucose profile was collected at Baseline and Week 52 at a subset of sites in a subset of participants per treatment group using the continuous glucose monitoring device. Glucose measurements were obtained at 5 minute increments in the 24-hour period. The area under the curve (AUC) was determined using the trapezoidal method on the measurements obtained during the first 24 hours of continuous monitoring. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. The Baseline value is the last non-missing value before the start of treatment.","timeFrame":"Baseline and Week 52"},{"measure":"Albiglutide Plasma Concentrations at Week 8 and Week 24","description":"Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post-dose, Week 24 pre-dose and Week 24 post-dose. All participants receiving albiglutide were initiated on a 30 mg weekly dosing regimen; however, beginning at Week 4, uptitration of albiglutide was allowed based on glycemic response. As such, albiglutide plasma concentrations achieved at each sampling time represent a mixed population of participants receiving either 30 mg or 50 mg weekly for various durations.","timeFrame":"Weeks 8 and 24"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* type 2 diabetes\n* BMI 20-45kg/m2 inclusive\n\nExclusion Criteria:\n\n* females who are pregnant, lactating or within \\<6 weeks post-partum\n* current symptomatic heart failure (NYHA Class III-IV)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"GSK Clinical Trials","affiliation":"GlaxoSmithKline","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"GSK Investigational Site","city":"Alabaster","state":"Alabama","zip":"35007","country":"United States","geoPoint":{"lat":33.24428,"lon":-86.81638}},{"facility":"GSK Investigational Site","city":"Birmingham","state":"Alabama","zip":"35205","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"GSK Investigational Site","city":"Birmingham","state":"Alabama","zip":"35235","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"GSK Investigational Site","city":"Dothan","state":"Alabama","zip":"36301","country":"United States","geoPoint":{"lat":31.22323,"lon":-85.39049}},{"facility":"GSK Investigational Site","city":"Hueytown","state":"Alabama","zip":"35023","country":"United States","geoPoint":{"lat":33.45122,"lon":-86.99666}},{"facility":"GSK Investigational Site","city":"Mobile","state":"Alabama","zip":"36617","country":"United States","geoPoint":{"lat":30.69436,"lon":-88.04305}},{"facility":"GSK Investigational Site","city":"Tuscaloosa","state":"Alabama","zip":"35406","country":"United States","geoPoint":{"lat":33.20984,"lon":-87.56917}},{"facility":"GSK Investigational Site","city":"Chandler","state":"Arizona","zip":"85224","country":"United States","geoPoint":{"lat":33.30616,"lon":-111.84125}},{"facility":"GSK Investigational Site","city":"Gilbert","state":"Arizona","zip":"85295","country":"United States","geoPoint":{"lat":33.35283,"lon":-111.78903}},{"facility":"GSK Investigational Site","city":"Green Valley","state":"Arizona","zip":"85614","country":"United States","geoPoint":{"lat":31.85425,"lon":-110.9937}},{"facility":"GSK Investigational Site","city":"Phoenix","state":"Arizona","zip":"85032","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"GSK Investigational Site","city":"Phoenix","state":"Arizona","zip":"85051","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"GSK Investigational Site","city":"Tucson","state":"Arizona","zip":"85712","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"facility":"GSK Investigational Site","city":"Tucson","state":"Arizona","zip":"85745","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"facility":"GSK Investigational Site","city":"Bull Shoals","state":"Arkansas","zip":"72619","country":"United States","geoPoint":{"lat":36.38396,"lon":-92.58155}},{"facility":"GSK Investigational Site","city":"Harrisburg","state":"Arkansas","zip":"72432","country":"United States","geoPoint":{"lat":35.56425,"lon":-90.71678}},{"facility":"GSK Investigational Site","city":"Hot Springs","state":"Arkansas","zip":"71913","country":"United States","geoPoint":{"lat":34.5037,"lon":-93.05518}},{"facility":"GSK Investigational Site","city":"Jonesboro","state":"Arkansas","zip":"72401","country":"United States","geoPoint":{"lat":35.8423,"lon":-90.70428}},{"facility":"GSK Investigational Site","city":"Little Rock","state":"Arkansas","zip":"72205","country":"United States","geoPoint":{"lat":34.74648,"lon":-92.28959}},{"facility":"GSK Investigational Site","city":"Searcy","state":"Arkansas","zip":"72143","country":"United States","geoPoint":{"lat":35.25064,"lon":-91.73625}},{"facility":"GSK Investigational Site","city":"Buena Park","state":"California","zip":"90620","country":"United States","geoPoint":{"lat":33.86751,"lon":-117.99812}},{"facility":"GSK Investigational Site","city":"Cathedral City","state":"California","zip":"92234","country":"United States","geoPoint":{"lat":33.77974,"lon":-116.46529}},{"facility":"GSK Investigational Site","city":"Chino","state":"California","zip":"91710","country":"United States","geoPoint":{"lat":34.01223,"lon":-117.68894}},{"facility":"GSK Investigational Site","city":"Chula Vista","state":"California","zip":"91911","country":"United States","geoPoint":{"lat":32.64005,"lon":-117.0842}},{"facility":"GSK Investigational Site","city":"Commerce","state":"California","zip":"90040","country":"United States","geoPoint":{"lat":34.00057,"lon":-118.15979}},{"facility":"GSK Investigational Site","city":"Escondido","state":"California","zip":"92026","country":"United States","geoPoint":{"lat":33.11921,"lon":-117.08642}},{"facility":"GSK Investigational Site","city":"Foothill Ranch","state":"California","zip":"92610","country":"United States","geoPoint":{"lat":33.68641,"lon":-117.66088}},{"facility":"GSK Investigational Site","city":"Fountain Valley","state":"California","zip":"92708","country":"United States","geoPoint":{"lat":33.70918,"lon":-117.95367}},{"facility":"GSK Investigational Site","city":"Fresno","state":"California","zip":"93720","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"GSK Investigational Site","city":"Fullerton","state":"California","zip":"92835","country":"United States","geoPoint":{"lat":33.87029,"lon":-117.92534}},{"facility":"GSK Investigational Site","city":"Huntington Beach","state":"California","zip":"92646","country":"United States","geoPoint":{"lat":33.6603,"lon":-117.99923}},{"facility":"GSK Investigational Site","city":"Huntington Beach","state":"California","zip":"92648","country":"United States","geoPoint":{"lat":33.6603,"lon":-117.99923}},{"facility":"GSK Investigational Site","city":"Irvine","state":"California","zip":"92618","country":"United States","geoPoint":{"lat":33.66946,"lon":-117.82311}},{"facility":"GSK Investigational Site","city":"La Jolla","state":"California","zip":"92037","country":"United States","geoPoint":{"lat":32.84727,"lon":-117.2742}},{"facility":"GSK Investigational Site","city":"Lakewood","state":"California","zip":"90712","country":"United States","geoPoint":{"lat":33.85363,"lon":-118.13396}},{"facility":"GSK Investigational Site","city":"Loma Linda","state":"California","zip":"92354","country":"United States","geoPoint":{"lat":34.04835,"lon":-117.26115}},{"facility":"GSK Investigational Site","city":"Long Beach","state":"California","zip":"90806","country":"United States","geoPoint":{"lat":33.76696,"lon":-118.18923}},{"facility":"GSK Investigational Site","city":"Los Alamitos","state":"California","zip":"90720","country":"United States","geoPoint":{"lat":33.80307,"lon":-118.07256}},{"facility":"GSK Investigational Site","city":"Los Angeles","state":"California","zip":"90017","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"GSK Investigational Site","city":"Los Angeles","state":"California","zip":"90022","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"GSK Investigational Site","city":"Los Angeles","state":"California","zip":"90025","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"GSK Investigational Site","city":"Mission Viejo","state":"California","zip":"92691","country":"United States","geoPoint":{"lat":33.60002,"lon":-117.672}},{"facility":"GSK Investigational Site","city":"Northridge","state":"California","zip":"91325","country":"United States","geoPoint":{"lat":34.22834,"lon":-118.53675}},{"facility":"GSK Investigational Site","city":"Palm Desert","state":"California","zip":"92260","country":"United States","geoPoint":{"lat":33.72255,"lon":-116.37697}},{"facility":"GSK Investigational Site","city":"Pasadena","state":"California","zip":"91105","country":"United States","geoPoint":{"lat":34.14778,"lon":-118.14452}},{"facility":"GSK Investigational Site","city":"Riverside","state":"California","zip":"92506","country":"United States","geoPoint":{"lat":33.95335,"lon":-117.39616}},{"facility":"GSK Investigational Site","city":"Sacramento","state":"California","zip":"95821","country":"United States","geoPoint":{"lat":38.58157,"lon":-121.4944}},{"facility":"GSK Investigational Site","city":"Sacramento","state":"California","zip":"95825","country":"United States","geoPoint":{"lat":38.58157,"lon":-121.4944}},{"facility":"GSK Investigational Site","city":"San Diego","state":"California","zip":"92117","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"GSK Investigational Site","city":"San Diego","state":"California","zip":"92120","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"GSK Investigational Site","city":"San Diego","state":"California","zip":"92128","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"GSK Investigational Site","city":"Satna Monica","state":"California","zip":"90404","country":"United States"},{"facility":"GSK Investigational Site","city":"Spring Valley","state":"California","zip":"91978","country":"United States","geoPoint":{"lat":32.74477,"lon":-116.99892}},{"facility":"GSK Investigational Site","city":"Tarzana","state":"California","zip":"91356","country":"United States","geoPoint":{"lat":34.17334,"lon":-118.55397}},{"facility":"GSK Investigational Site","city":"Tustin","state":"California","zip":"92780","country":"United States","geoPoint":{"lat":33.74585,"lon":-117.82617}},{"facility":"GSK Investigational Site","city":"Victorville","state":"California","zip":"92395","country":"United States","geoPoint":{"lat":34.53611,"lon":-117.29116}},{"facility":"GSK Investigational Site","city":"Vista","state":"California","zip":"92083","country":"United States","geoPoint":{"lat":33.20004,"lon":-117.24254}},{"facility":"GSK Investigational Site","city":"West Hills","state":"California","zip":"91307","country":"United States","geoPoint":{"lat":34.19731,"lon":-118.64398}},{"facility":"GSK Investigational Site","city":"Denver","state":"Colorado","zip":"80209","country":"United States","geoPoint":{"lat":39.73915,"lon":-104.9847}},{"facility":"GSK Investigational Site","city":"New Britain","state":"Connecticut","zip":"06050","country":"United States","geoPoint":{"lat":41.66121,"lon":-72.77954}},{"facility":"GSK Investigational Site","city":"Trumbull","state":"Connecticut","zip":"06611","country":"United States","geoPoint":{"lat":41.24287,"lon":-73.20067}},{"facility":"GSK Investigational Site","city":"Waterbury","state":"Connecticut","zip":"06708","country":"United States","geoPoint":{"lat":41.55815,"lon":-73.0515}},{"facility":"GSK Investigational Site","city":"Middletown","state":"Delaware","zip":"19709","country":"United States","geoPoint":{"lat":39.44956,"lon":-75.71632}},{"facility":"GSK Investigational Site","city":"Boynton Beach","state":"Florida","zip":"33426","country":"United States","geoPoint":{"lat":26.52535,"lon":-80.06643}},{"facility":"GSK Investigational Site","city":"Boynton Beach","state":"Florida","zip":"33437","country":"United States","geoPoint":{"lat":26.52535,"lon":-80.06643}},{"facility":"GSK Investigational Site","city":"Clearwater","state":"Florida","zip":"33756","country":"United States","geoPoint":{"lat":27.96585,"lon":-82.8001}},{"facility":"GSK Investigational Site","city":"Clearwater","state":"Florida","zip":"33765","country":"United States","geoPoint":{"lat":27.96585,"lon":-82.8001}},{"facility":"GSK Investigational Site","city":"Cocoa","state":"Florida","zip":"32927","country":"United States","geoPoint":{"lat":28.38612,"lon":-80.742}},{"facility":"GSK Investigational Site","city":"Cutler Bay","state":"Florida","zip":"33189","country":"United States","geoPoint":{"lat":25.5783,"lon":-80.3377}},{"facility":"GSK Investigational Site","city":"Deerfield Beach","state":"Florida","zip":"33442","country":"United States","geoPoint":{"lat":26.31841,"lon":-80.09977}},{"facility":"GSK Investigational Site","city":"Delray Beach","state":"Florida","zip":"33445","country":"United States","geoPoint":{"lat":26.46146,"lon":-80.07282}},{"facility":"GSK Investigational Site","city":"Edgewater","state":"Florida","zip":"32132","country":"United States","geoPoint":{"lat":28.98888,"lon":-80.90228}},{"facility":"GSK Investigational Site","city":"Fort Lauderdale","state":"Florida","zip":"33316","country":"United States","geoPoint":{"lat":26.12231,"lon":-80.14338}},{"facility":"GSK Investigational Site","city":"Gainesville","state":"Florida","zip":"32605","country":"United States","geoPoint":{"lat":29.65163,"lon":-82.32483}},{"facility":"GSK Investigational Site","city":"Hallandale","state":"Florida","zip":"33009","country":"United States","geoPoint":{"lat":25.9812,"lon":-80.14838}},{"facility":"GSK Investigational Site","city":"Hialeah","state":"Florida","zip":"33012","country":"United States","geoPoint":{"lat":25.8576,"lon":-80.27811}},{"facility":"GSK Investigational Site","city":"Hialeah","state":"Florida","zip":"33013","country":"United States","geoPoint":{"lat":25.8576,"lon":-80.27811}},{"facility":"GSK Investigational Site","city":"Hollywood","state":"Florida","zip":"33023","country":"United States","geoPoint":{"lat":26.0112,"lon":-80.14949}},{"facility":"GSK Investigational Site","city":"Jacksonville","state":"Florida","zip":"32205","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"GSK Investigational Site","city":"Lauderdale Lakes","state":"Florida","zip":"33319","country":"United States","geoPoint":{"lat":26.16647,"lon":-80.20838}},{"facility":"GSK Investigational Site","city":"Marianna","state":"Florida","zip":"32446","country":"United States","geoPoint":{"lat":30.77436,"lon":-85.22687}},{"facility":"GSK Investigational Site","city":"Miami","state":"Florida","zip":"33135","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"GSK Investigational Site","city":"Miami","state":"Florida","zip":"33156","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"GSK Investigational Site","city":"North Miami","state":"Florida","zip":"33161","country":"United States","geoPoint":{"lat":25.89009,"lon":-80.18671}},{"facility":"GSK Investigational Site","city":"Ocala","state":"Florida","zip":"34471","country":"United States","geoPoint":{"lat":29.1872,"lon":-82.14009}},{"facility":"GSK Investigational Site","city":"Orlando","state":"Florida","zip":"32822","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"GSK Investigational Site","city":"Ormond Beach","state":"Florida","zip":"32174","country":"United States","geoPoint":{"lat":29.28581,"lon":-81.05589}},{"facility":"GSK Investigational Site","city":"Oviedo","state":"Florida","zip":"32765","country":"United States","geoPoint":{"lat":28.67,"lon":-81.20812}},{"facility":"GSK Investigational Site","city":"Panama City","state":"Florida","zip":"32401","country":"United States","geoPoint":{"lat":30.15946,"lon":-85.65983}},{"facility":"GSK Investigational Site","city":"Pembroke Pines","state":"Florida","zip":"33026","country":"United States","geoPoint":{"lat":26.00315,"lon":-80.22394}},{"facility":"GSK Investigational Site","city":"Plantation","state":"Florida","zip":"33317","country":"United States","geoPoint":{"lat":26.13421,"lon":-80.23184}},{"facility":"GSK Investigational Site","city":"Ponte Verda","state":"Florida","zip":"32081","country":"United States"},{"facility":"GSK Investigational Site","city":"Saint Cloud","state":"Florida","zip":"34769","country":"United States","geoPoint":{"lat":28.2489,"lon":-81.28118}},{"facility":"GSK Investigational Site","city":"St. Petersburg","state":"Florida","zip":"33709","country":"United States","geoPoint":{"lat":27.77086,"lon":-82.67927}},{"facility":"GSK Investigational Site","city":"Tampa","state":"Florida","zip":"33603","country":"United States","geoPoint":{"lat":27.94752,"lon":-82.45843}},{"facility":"GSK Investigational Site","city":"West Palm Beach","state":"Florida","zip":"33401","country":"United States","geoPoint":{"lat":26.71534,"lon":-80.05337}},{"facility":"GSK Investigational Site","city":"Atlanta","state":"Georgia","zip":"30308","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"GSK Investigational Site","city":"Atlanta","state":"Georgia","zip":"30309","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"GSK Investigational Site","city":"Atlanta","state":"Georgia","zip":"30312","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"GSK Investigational Site","city":"Atlanta","state":"Georgia","zip":"30328","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"GSK Investigational Site","city":"Atlanta","state":"Georgia","zip":"30338","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"GSK Investigational Site","city":"Atlanta","state":"Georgia","zip":"30342","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"GSK Investigational Site","city":"Blue Ridge","state":"Georgia","zip":"30513","country":"United States","geoPoint":{"lat":34.86397,"lon":-84.32409}},{"facility":"GSK Investigational Site","city":"Columbus","state":"Georgia","zip":"31904","country":"United States","geoPoint":{"lat":32.46098,"lon":-84.98771}},{"facility":"GSK Investigational Site","city":"Decatur","state":"Georgia","zip":"30032","country":"United States","geoPoint":{"lat":33.77483,"lon":-84.29631}},{"facility":"GSK Investigational Site","city":"Savannah","state":"Georgia","zip":"31406","country":"United States","geoPoint":{"lat":32.08354,"lon":-81.09983}},{"facility":"GSK Investigational Site","city":"Savannah","state":"Georgia","zip":"31419","country":"United States","geoPoint":{"lat":32.08354,"lon":-81.09983}},{"facility":"GSK Investigational Site","city":"Snellville","state":"Georgia","zip":"30078","country":"United States","geoPoint":{"lat":33.85733,"lon":-84.01991}},{"facility":"GSK Investigational Site","city":"Stone Mountain","state":"Georgia","zip":"30088","country":"United States","geoPoint":{"lat":33.80816,"lon":-84.1702}},{"facility":"GSK Investigational Site","city":"Honolulu","state":"Hawaii","zip":"96813","country":"United States","geoPoint":{"lat":21.30694,"lon":-157.85833}},{"facility":"GSK Investigational Site","city":"Honolulu","state":"Hawaii","zip":"96814","country":"United States","geoPoint":{"lat":21.30694,"lon":-157.85833}},{"facility":"GSK Investigational Site","city":"Boise","state":"Idaho","zip":"83702","country":"United States","geoPoint":{"lat":43.6135,"lon":-116.20345}},{"facility":"GSK Investigational Site","city":"Idaho Falls","state":"Idaho","zip":"83404","country":"United States","geoPoint":{"lat":43.46658,"lon":-112.03414}},{"facility":"GSK Investigational Site","city":"Aurora","state":"Illinois","zip":"60504","country":"United States","geoPoint":{"lat":41.76058,"lon":-88.32007}},{"facility":"GSK Investigational Site","city":"Chicago","state":"Illinois","zip":"60607","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"GSK Investigational Site","city":"Evergreen Park","state":"Illinois","zip":"60805","country":"United States","geoPoint":{"lat":41.72059,"lon":-87.70172}},{"facility":"GSK Investigational Site","city":"Gurnee","state":"Illinois","zip":"60031","country":"United States","geoPoint":{"lat":42.3703,"lon":-87.90202}},{"facility":"GSK Investigational Site","city":"La Grange","state":"Illinois","zip":"60525","country":"United States","geoPoint":{"lat":41.80503,"lon":-87.86923}},{"facility":"GSK Investigational Site","city":"Naperville","state":"Illinois","zip":"60564","country":"United States","geoPoint":{"lat":41.78586,"lon":-88.14729}},{"facility":"GSK Investigational Site","city":"Peoria","state":"Illinois","zip":"61602","country":"United States","geoPoint":{"lat":40.69365,"lon":-89.58899}},{"facility":"GSK Investigational Site","city":"Avon","state":"Indiana","zip":"46123","country":"United States","geoPoint":{"lat":39.76282,"lon":-86.39972}},{"facility":"GSK Investigational Site","city":"Evansville","state":"Indiana","zip":"47714","country":"United States","geoPoint":{"lat":37.97476,"lon":-87.55585}},{"facility":"GSK Investigational Site","city":"Fishers","state":"Indiana","zip":"46037","country":"United States","geoPoint":{"lat":39.95559,"lon":-86.01387}},{"facility":"GSK Investigational Site","city":"Indianapolis","state":"Indiana","zip":"46254","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"GSK Investigational Site","city":"La Porte","state":"Indiana","zip":"46350","country":"United States","geoPoint":{"lat":41.60774,"lon":-86.71389}},{"facility":"GSK Investigational Site","city":"Lafayette","state":"Indiana","zip":"47904","country":"United States","geoPoint":{"lat":40.4167,"lon":-86.87529}},{"facility":"GSK Investigational Site","city":"South Bend","state":"Indiana","zip":"46614","country":"United States","geoPoint":{"lat":41.68338,"lon":-86.25001}},{"facility":"GSK Investigational Site","city":"Council Bluffs","state":"Iowa","zip":"51501","country":"United States","geoPoint":{"lat":41.26194,"lon":-95.86083}},{"facility":"GSK Investigational Site","city":"Des Moines","state":"Iowa","zip":"50314","country":"United States","geoPoint":{"lat":41.60054,"lon":-93.60911}},{"facility":"GSK Investigational Site","city":"Dubuque","state":"Iowa","zip":"52001","country":"United States","geoPoint":{"lat":42.50056,"lon":-90.66457}},{"facility":"GSK Investigational Site","city":"Iowa City","state":"Iowa","zip":"52243","country":"United States","geoPoint":{"lat":41.66113,"lon":-91.53017}},{"facility":"GSK Investigational Site","city":"Waterloo","state":"Iowa","zip":"50701","country":"United States","geoPoint":{"lat":42.49276,"lon":-92.34296}},{"facility":"GSK Investigational Site","city":"Arkansas City","state":"Kansas","zip":"67005","country":"United States","geoPoint":{"lat":37.06197,"lon":-97.03837}},{"facility":"GSK Investigational Site","city":"Mission","state":"Kansas","zip":"66202","country":"United States","geoPoint":{"lat":39.02778,"lon":-94.65579}},{"facility":"GSK Investigational Site","city":"Newton","state":"Kansas","zip":"67114","country":"United States","geoPoint":{"lat":38.04668,"lon":-97.34504}},{"facility":"GSK Investigational Site","city":"Overland Park","state":"Kansas","zip":"66211","country":"United States","geoPoint":{"lat":38.98223,"lon":-94.67079}},{"facility":"GSK Investigational Site","city":"Topeka","state":"Kansas","zip":"66606","country":"United States","geoPoint":{"lat":39.04833,"lon":-95.67804}},{"facility":"GSK Investigational Site","city":"Wichita","state":"Kansas","zip":"67211","country":"United States","geoPoint":{"lat":37.69224,"lon":-97.33754}},{"facility":"GSK Investigational Site","city":"Fort Mitchell","state":"Kentucky","zip":"41017","country":"United States","geoPoint":{"lat":39.0595,"lon":-84.54744}},{"facility":"GSK Investigational Site","city":"Lexington","state":"Kentucky","zip":"40503","country":"United States","geoPoint":{"lat":37.98869,"lon":-84.47772}},{"facility":"GSK Investigational Site","city":"Lexington","state":"Kentucky","zip":"40504","country":"United States","geoPoint":{"lat":37.98869,"lon":-84.47772}},{"facility":"GSK Investigational Site","city":"Louisville","state":"Kentucky","zip":"40202","country":"United States","geoPoint":{"lat":38.25424,"lon":-85.75941}},{"facility":"GSK Investigational Site","city":"Madisonville","state":"Kentucky","zip":"42431","country":"United States","geoPoint":{"lat":37.3281,"lon":-87.49889}},{"facility":"GSK Investigational Site","city":"Paducah","state":"Kentucky","zip":"42003","country":"United States","geoPoint":{"lat":37.08339,"lon":-88.60005}},{"facility":"GSK Investigational Site","city":"Covington","state":"Louisiana","zip":"70433","country":"United States","geoPoint":{"lat":30.47549,"lon":-90.10042}},{"facility":"GSK Investigational Site","city":"Lake Charles","state":"Louisiana","zip":"70601","country":"United States","geoPoint":{"lat":30.21309,"lon":-93.2044}},{"facility":"GSK Investigational Site","city":"Shreveport","state":"Louisiana","zip":"71101","country":"United States","geoPoint":{"lat":32.52515,"lon":-93.75018}},{"facility":"GSK Investigational Site","city":"Shreveport","state":"Louisiana","zip":"71115","country":"United States","geoPoint":{"lat":32.52515,"lon":-93.75018}},{"facility":"GSK Investigational Site","city":"Baltimore","state":"Maryland","zip":"21237","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}},{"facility":"GSK Investigational Site","city":"Hyattsville","state":"Maryland","zip":"20782","country":"United States","geoPoint":{"lat":38.95594,"lon":-76.94553}},{"facility":"GSK Investigational Site","city":"Oxon Hill","state":"Maryland","zip":"20745","country":"United States","geoPoint":{"lat":38.80345,"lon":-76.9897}},{"facility":"GSK Investigational Site","city":"Haverhill","state":"Massachusetts","zip":"01830","country":"United States","geoPoint":{"lat":42.7762,"lon":-71.07728}},{"facility":"GSK Investigational Site","city":"Bay City","state":"Michigan","zip":"48706","country":"United States","geoPoint":{"lat":43.59447,"lon":-83.88886}},{"facility":"GSK Investigational Site","city":"Benzonia","state":"Michigan","zip":"49616","country":"United States","geoPoint":{"lat":44.62139,"lon":-86.09926}},{"facility":"GSK Investigational Site","city":"Bloomfield Hills","state":"Michigan","zip":"48302","country":"United States","geoPoint":{"lat":42.58364,"lon":-83.24549}},{"facility":"GSK Investigational Site","city":"Cadillac","state":"Michigan","zip":"49601","country":"United States","geoPoint":{"lat":44.25195,"lon":-85.40116}},{"facility":"GSK Investigational Site","city":"Dearborn","state":"Michigan","zip":"48124","country":"United States","geoPoint":{"lat":42.32226,"lon":-83.17631}},{"facility":"GSK Investigational Site","city":"Interlochen","state":"Michigan","zip":"49643","country":"United States","geoPoint":{"lat":44.64472,"lon":-85.7673}},{"facility":"GSK Investigational Site","city":"Kalamazoo","state":"Michigan","zip":"49009","country":"United States","geoPoint":{"lat":42.29171,"lon":-85.58723}},{"facility":"GSK Investigational Site","city":"Kalamazoo","state":"Michigan","zip":"49048","country":"United States","geoPoint":{"lat":42.29171,"lon":-85.58723}},{"facility":"GSK Investigational Site","city":"Saint Clair Shores","state":"Michigan","zip":"48081","country":"United States","geoPoint":{"lat":42.49698,"lon":-82.88881}},{"facility":"GSK Investigational Site","city":"Brooklyn Center","state":"Minnesota","zip":"55430","country":"United States","geoPoint":{"lat":45.07608,"lon":-93.33273}},{"facility":"GSK Investigational Site","city":"Gulfport","state":"Mississippi","zip":"39501","country":"United States","geoPoint":{"lat":30.36742,"lon":-89.09282}},{"facility":"GSK Investigational Site","city":"Picayune","state":"Mississippi","zip":"39466","country":"United States","geoPoint":{"lat":30.52556,"lon":-89.67788}},{"facility":"GSK Investigational Site","city":"Rolling Fork","state":"Mississippi","zip":"39159","country":"United States","geoPoint":{"lat":32.90652,"lon":-90.87816}},{"facility":"GSK Investigational Site","city":"Chesterfield","state":"Missouri","zip":"63017","country":"United States","geoPoint":{"lat":38.66311,"lon":-90.57707}},{"facility":"GSK Investigational Site","city":"Jefferson City","state":"Missouri","zip":"65109","country":"United States","geoPoint":{"lat":38.5767,"lon":-92.17352}},{"facility":"GSK Investigational Site","city":"Kansas City","state":"Missouri","zip":"64106","country":"United States","geoPoint":{"lat":39.09973,"lon":-94.57857}},{"facility":"GSK Investigational Site","city":"Kansas City","state":"Missouri","country":"United States","geoPoint":{"lat":39.09973,"lon":-94.57857}},{"facility":"GSK Investigational Site","city":"St Louis","state":"Missouri","zip":"63108","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"GSK Investigational Site","city":"St Louis","state":"Missouri","zip":"63117","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"GSK Investigational Site","city":"West Plains","state":"Missouri","zip":"65775","country":"United States","geoPoint":{"lat":36.72812,"lon":-91.85237}},{"facility":"GSK Investigational Site","city":"Butte","state":"Montana","zip":"59701","country":"United States","geoPoint":{"lat":46.00382,"lon":-112.53474}},{"facility":"GSK Investigational Site","city":"Great Falls","state":"Montana","zip":"59405","country":"United States","geoPoint":{"lat":47.50024,"lon":-111.30081}},{"facility":"GSK Investigational Site","city":"Broken Bow","state":"Nebraska","zip":"68822","country":"United States","geoPoint":{"lat":41.40195,"lon":-99.63928}},{"facility":"GSK Investigational Site","city":"Lincoln","state":"Nebraska","zip":"68516","country":"United States","geoPoint":{"lat":40.8,"lon":-96.66696}},{"facility":"GSK Investigational Site","city":"Omaha","state":"Nebraska","zip":"68124","country":"United States","geoPoint":{"lat":41.25626,"lon":-95.94043}},{"facility":"GSK Investigational Site","city":"Omaha","state":"Nebraska","zip":"68131","country":"United States","geoPoint":{"lat":41.25626,"lon":-95.94043}},{"facility":"GSK Investigational Site","city":"Omaha","state":"Nebraska","zip":"68134","country":"United States","geoPoint":{"lat":41.25626,"lon":-95.94043}},{"facility":"GSK Investigational Site","city":"Las Vegas","state":"Nevada","zip":"89102","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"GSK Investigational Site","city":"Las Vegas","state":"Nevada","zip":"89103","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"GSK Investigational Site","city":"Las Vegas","state":"Nevada","zip":"89106","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"GSK Investigational Site","city":"Las Vegas","state":"Nevada","zip":"89128","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"GSK Investigational Site","city":"Las Vegas","state":"Nevada","zip":"89130","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"GSK Investigational Site","city":"Berlin","state":"New Jersey","zip":"08009","country":"United States","geoPoint":{"lat":39.79123,"lon":-74.92905}},{"facility":"GSK Investigational Site","city":"Elizabeth","state":"New Jersey","zip":"07202","country":"United States","geoPoint":{"lat":40.66399,"lon":-74.2107}},{"facility":"GSK Investigational Site","city":"Haddon Heights","state":"New Jersey","zip":"08035","country":"United States","geoPoint":{"lat":39.87734,"lon":-75.06462}},{"facility":"GSK Investigational Site","city":"Hainesport","state":"New Jersey","zip":"08036","country":"United States","geoPoint":{"lat":39.98372,"lon":-74.82711}},{"facility":"GSK Investigational Site","city":"New Brunswick","state":"New Jersey","zip":"08903","country":"United States","geoPoint":{"lat":40.48622,"lon":-74.45182}},{"facility":"GSK Investigational Site","city":"Stratford","state":"New Jersey","zip":"08084","country":"United States","geoPoint":{"lat":39.82678,"lon":-75.01545}},{"facility":"GSK Investigational Site","city":"Albuquerque","state":"New Mexico","zip":"87106","country":"United States","geoPoint":{"lat":35.08449,"lon":-106.65114}},{"facility":"GSK Investigational Site","city":"New York","state":"New York","zip":"10022","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"GSK Investigational Site","city":"North Massapequa","state":"New York","zip":"11758","country":"United States","geoPoint":{"lat":40.70093,"lon":-73.46207}},{"facility":"GSK Investigational Site","city":"Syracuse","state":"New York","zip":"13210","country":"United States","geoPoint":{"lat":43.04812,"lon":-76.14742}},{"facility":"GSK Investigational Site","city":"Asheville","state":"North Carolina","zip":"28803","country":"United States","geoPoint":{"lat":35.60095,"lon":-82.55402}},{"facility":"GSK Investigational Site","city":"Burlington","state":"North Carolina","zip":"27215","country":"United States","geoPoint":{"lat":36.09569,"lon":-79.4378}},{"facility":"GSK Investigational Site","city":"Calabash","state":"North Carolina","zip":"28467","country":"United States","geoPoint":{"lat":33.89073,"lon":-78.56834}},{"facility":"GSK Investigational Site","city":"Fayetteville","state":"North Carolina","zip":"28304","country":"United States","geoPoint":{"lat":35.05266,"lon":-78.87836}},{"facility":"GSK Investigational Site","city":"Greensboro","state":"North Carolina","zip":"27405","country":"United States","geoPoint":{"lat":36.07264,"lon":-79.79198}},{"facility":"GSK Investigational Site","city":"Hickory","state":"North Carolina","zip":"28601","country":"United States","geoPoint":{"lat":35.73319,"lon":-81.3412}},{"facility":"GSK Investigational Site","city":"Lenoir","state":"North Carolina","zip":"28645","country":"United States","geoPoint":{"lat":35.91402,"lon":-81.53898}},{"facility":"GSK Investigational Site","city":"Mint Hill","state":"North Carolina","zip":"28227","country":"United States","geoPoint":{"lat":35.17959,"lon":-80.64729}},{"facility":"GSK Investigational Site","city":"Morehead City","state":"North Carolina","zip":"28557","country":"United States","geoPoint":{"lat":34.72294,"lon":-76.72604}},{"facility":"GSK Investigational Site","city":"Shelby","state":"North Carolina","zip":"28150","country":"United States","geoPoint":{"lat":35.29235,"lon":-81.53565}},{"facility":"GSK Investigational Site","city":"Tabor City","state":"North Carolina","zip":"28463","country":"United States","geoPoint":{"lat":34.14878,"lon":-78.87669}},{"facility":"GSK Investigational Site","city":"Akron","state":"Ohio","zip":"44320","country":"United States","geoPoint":{"lat":41.08144,"lon":-81.51901}},{"facility":"GSK Investigational Site","city":"Canal Fulton","state":"Ohio","zip":"44614","country":"United States","geoPoint":{"lat":40.88978,"lon":-81.59762}},{"facility":"GSK Investigational Site","city":"Cincinnati","state":"Ohio","zip":"45227","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"GSK Investigational Site","city":"Cincinnati","state":"Ohio","zip":"45245","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"GSK Investigational Site","city":"Cleveland","state":"Ohio","zip":"44122","country":"United States","geoPoint":{"lat":41.4995,"lon":-81.69541}},{"facility":"GSK Investigational Site","city":"Columbus","state":"Ohio","zip":"43212","country":"United States","geoPoint":{"lat":39.96118,"lon":-82.99879}},{"facility":"GSK Investigational Site","city":"Columbus","state":"Ohio","zip":"43213","country":"United States","geoPoint":{"lat":39.96118,"lon":-82.99879}},{"facility":"GSK Investigational Site","city":"Dayton","state":"Ohio","zip":"45432","country":"United States","geoPoint":{"lat":39.75895,"lon":-84.19161}},{"facility":"GSK Investigational Site","city":"Dayton","state":"Ohio","zip":"45439","country":"United States","geoPoint":{"lat":39.75895,"lon":-84.19161}},{"facility":"GSK Investigational Site","city":"Kettering","state":"Ohio","zip":"45429","country":"United States","geoPoint":{"lat":39.6895,"lon":-84.16883}},{"facility":"GSK Investigational Site","city":"Mason","state":"Ohio","zip":"45040","country":"United States","geoPoint":{"lat":39.36006,"lon":-84.30994}},{"facility":"GSK Investigational Site","city":"Maumee","state":"Ohio","zip":"43537-9402","country":"United States","geoPoint":{"lat":41.56283,"lon":-83.65382}},{"facility":"GSK Investigational Site","city":"Thornville","state":"Ohio","zip":"43076","country":"United States","geoPoint":{"lat":39.89645,"lon":-82.42015}},{"facility":"GSK Investigational Site","city":"Zanesville","state":"Ohio","zip":"43701","country":"United States","geoPoint":{"lat":39.94035,"lon":-82.01319}},{"facility":"GSK Investigational Site","city":"Oklahoma City","state":"Oklahoma","zip":"73103","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"GSK Investigational Site","city":"Oklahoma City","state":"Oklahoma","zip":"73116","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"GSK Investigational Site","city":"Tulsa","state":"Oklahoma","zip":"74104","country":"United States","geoPoint":{"lat":36.15398,"lon":-95.99277}},{"facility":"GSK Investigational Site","city":"Tulsa","state":"Oklahoma","zip":"74136","country":"United States","geoPoint":{"lat":36.15398,"lon":-95.99277}},{"facility":"GSK Investigational Site","city":"Ashland","state":"Oregon","zip":"97520","country":"United States","geoPoint":{"lat":42.19458,"lon":-122.70948}},{"facility":"GSK Investigational Site","city":"Bensalem","state":"Pennsylvania","zip":"19020","country":"United States","geoPoint":{"lat":40.10455,"lon":-74.95128}},{"facility":"GSK Investigational Site","city":"Carlisle","state":"Pennsylvania","zip":"17013","country":"United States","geoPoint":{"lat":40.20148,"lon":-77.18887}},{"facility":"GSK Investigational Site","city":"Downington","state":"Pennsylvania","zip":"19335","country":"United States"},{"facility":"GSK Investigational Site","city":"Harrisburg","state":"Pennsylvania","zip":"17112","country":"United States","geoPoint":{"lat":40.2737,"lon":-76.88442}},{"facility":"GSK Investigational Site","city":"Landsdale","state":"Pennsylvania","zip":"19446","country":"United States"},{"facility":"GSK Investigational Site","city":"Pittsburgh","state":"Pennsylvania","zip":"15243","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}},{"facility":"GSK Investigational Site","city":"Tipton","state":"Pennsylvania","zip":"16684","country":"United States","geoPoint":{"lat":40.6359,"lon":-78.29585}},{"facility":"GSK Investigational Site","city":"Uniontown","state":"Pennsylvania","zip":"15401","country":"United States","geoPoint":{"lat":39.90008,"lon":-79.71643}},{"facility":"GSK Investigational Site","city":"East Providence","state":"Rhode Island","zip":"02914","country":"United States","geoPoint":{"lat":41.81371,"lon":-71.37005}},{"facility":"GSK Investigational Site","city":"Columbia","state":"South Carolina","zip":"29201","country":"United States","geoPoint":{"lat":34.00071,"lon":-81.03481}},{"facility":"GSK Investigational Site","city":"Greenville","state":"South Carolina","zip":"29601","country":"United States","geoPoint":{"lat":34.85262,"lon":-82.39401}},{"facility":"GSK Investigational Site","city":"Greenville","state":"South Carolina","zip":"29615","country":"United States","geoPoint":{"lat":34.85262,"lon":-82.39401}},{"facility":"GSK Investigational Site","city":"Greer","state":"South Carolina","zip":"29651","country":"United States","geoPoint":{"lat":34.93873,"lon":-82.22706}},{"facility":"GSK Investigational Site","city":"Manning","state":"South Carolina","zip":"29102","country":"United States","geoPoint":{"lat":33.69516,"lon":-80.21091}},{"facility":"GSK Investigational Site","city":"Murrells Inlet","state":"South Carolina","zip":"29576","country":"United States","geoPoint":{"lat":33.551,"lon":-79.04143}},{"facility":"GSK Investigational Site","city":"North Myrtle Beach","state":"South Carolina","zip":"29582","country":"United States","geoPoint":{"lat":33.81601,"lon":-78.68002}},{"facility":"GSK Investigational Site","city":"Orangeburg","state":"South Carolina","zip":"29115","country":"United States","geoPoint":{"lat":33.49182,"lon":-80.85565}},{"facility":"GSK Investigational Site","city":"Simpsonville","state":"South Carolina","zip":"29681","country":"United States","geoPoint":{"lat":34.73706,"lon":-82.25428}},{"facility":"GSK Investigational Site","city":"Taylors","state":"South Carolina","zip":"29687","country":"United States","geoPoint":{"lat":34.92039,"lon":-82.29623}},{"facility":"GSK Investigational Site","city":"Bristol","state":"Tennessee","zip":"37620","country":"United States","geoPoint":{"lat":36.59511,"lon":-82.18874}},{"facility":"GSK Investigational Site","city":"Chattanooga","state":"Tennessee","zip":"37421","country":"United States","geoPoint":{"lat":35.04563,"lon":-85.30968}},{"facility":"GSK Investigational Site","city":"Clarksville","state":"Tennessee","zip":"37043","country":"United States","geoPoint":{"lat":36.52977,"lon":-87.35945}},{"facility":"GSK Investigational Site","city":"Columbia","state":"Tennessee","zip":"38401","country":"United States","geoPoint":{"lat":35.61507,"lon":-87.03528}},{"facility":"GSK Investigational Site","city":"Fayetteville","state":"Tennessee","zip":"37334","country":"United States","geoPoint":{"lat":35.15203,"lon":-86.57055}},{"facility":"GSK Investigational Site","city":"Johnson City","state":"Tennessee","zip":"37604","country":"United States","geoPoint":{"lat":36.31344,"lon":-82.35347}},{"facility":"GSK Investigational Site","city":"McKenzie","state":"Tennessee","zip":"38201","country":"United States","geoPoint":{"lat":36.13256,"lon":-88.51866}},{"facility":"GSK Investigational Site","city":"Nashville","state":"Tennessee","zip":"37203","country":"United States","geoPoint":{"lat":36.16589,"lon":-86.78444}},{"facility":"GSK Investigational Site","city":"Tullahoma","state":"Tennessee","zip":"37398","country":"United States","geoPoint":{"lat":35.36202,"lon":-86.20943}},{"facility":"GSK Investigational Site","city":"Arlington","state":"Texas","zip":"76012","country":"United States","geoPoint":{"lat":32.73569,"lon":-97.10807}},{"facility":"GSK Investigational Site","city":"Bedford","state":"Texas","zip":"76201","country":"United States","geoPoint":{"lat":32.84402,"lon":-97.14307}},{"facility":"GSK Investigational Site","city":"Cleburne","state":"Texas","zip":"76033","country":"United States","geoPoint":{"lat":32.34764,"lon":-97.38668}},{"facility":"GSK Investigational Site","city":"Corpus Christi","state":"Texas","zip":"78404","country":"United States","geoPoint":{"lat":27.80058,"lon":-97.39638}},{"facility":"GSK Investigational Site","city":"Corpus Christi","state":"Texas","zip":"78414","country":"United States","geoPoint":{"lat":27.80058,"lon":-97.39638}},{"facility":"GSK Investigational Site","city":"Dallas","state":"Texas","zip":"75224","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"GSK Investigational Site","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"GSK Investigational Site","city":"Dallas","state":"Texas","zip":"75235","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"GSK Investigational Site","city":"Dallas","state":"Texas","zip":"75246","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"GSK Investigational Site","city":"Dallas","state":"Texas","zip":"75251","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"GSK Investigational Site","city":"Deer Park","state":"Texas","zip":"77536","country":"United States","geoPoint":{"lat":29.70523,"lon":-95.12382}},{"facility":"GSK Investigational Site","city":"El Paso","state":"Texas","zip":"79925","country":"United States","geoPoint":{"lat":31.75872,"lon":-106.48693}},{"facility":"GSK Investigational Site","city":"Fort Worth","state":"Texas","zip":"76104","country":"United States","geoPoint":{"lat":32.72541,"lon":-97.32085}},{"facility":"GSK Investigational Site","city":"Fort Worth","state":"Texas","zip":"76135","country":"United States","geoPoint":{"lat":32.72541,"lon":-97.32085}},{"facility":"GSK Investigational Site","city":"Houston","state":"Texas","zip":"77024","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"GSK Investigational Site","city":"Houston","state":"Texas","zip":"77027","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"GSK Investigational Site","city":"Houston","state":"Texas","zip":"77030","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"GSK Investigational Site","city":"Houston","state":"Texas","zip":"77034","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"GSK Investigational Site","city":"Houston","state":"Texas","zip":"77036","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"GSK Investigational Site","city":"Houston","state":"Texas","zip":"77055","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"GSK Investigational Site","city":"Houston","state":"Texas","zip":"77058","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"GSK Investigational Site","city":"Houston","state":"Texas","zip":"77070","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"GSK Investigational Site","city":"Houston","state":"Texas","zip":"77074","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"GSK Investigational Site","city":"Houston","state":"Texas","zip":"77094","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"GSK Investigational Site","city":"Hurst","state":"Texas","zip":"76054","country":"United States","geoPoint":{"lat":32.82346,"lon":-97.17057}},{"facility":"GSK Investigational Site","city":"Katy","state":"Texas","zip":"77450","country":"United States","geoPoint":{"lat":29.78579,"lon":-95.8244}},{"facility":"GSK Investigational Site","city":"Lake Jackson","state":"Texas","zip":"77566","country":"United States","geoPoint":{"lat":29.03386,"lon":-95.43439}},{"facility":"GSK Investigational Site","city":"Lewisville","state":"Texas","zip":"75067","country":"United States","geoPoint":{"lat":33.04623,"lon":-96.99417}},{"facility":"GSK Investigational Site","city":"Midland","state":"Texas","zip":"79705","country":"United States","geoPoint":{"lat":31.99735,"lon":-102.07791}},{"facility":"GSK Investigational Site","city":"North Richland Hills","state":"Texas","zip":"76180","country":"United States","geoPoint":{"lat":32.8343,"lon":-97.2289}},{"facility":"GSK Investigational Site","city":"Odessa","state":"Texas","zip":"79761","country":"United States","geoPoint":{"lat":31.84568,"lon":-102.36764}},{"facility":"GSK Investigational Site","city":"San Antonio","state":"Texas","zip":"78205","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"GSK Investigational Site","city":"San Antonio","state":"Texas","zip":"78215","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"GSK Investigational Site","city":"San Antonio","state":"Texas","zip":"78217","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"GSK Investigational Site","city":"San Antonio","state":"Texas","zip":"78218","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"GSK Investigational Site","city":"San Antonio","state":"Texas","zip":"78224","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"GSK Investigational Site","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"GSK Investigational Site","city":"San Antonio","state":"Texas","zip":"78258","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"GSK Investigational Site","city":"Schertz","state":"Texas","zip":"78154","country":"United States","geoPoint":{"lat":29.55217,"lon":-98.26973}},{"facility":"GSK Investigational Site","city":"Sugar Land","state":"Texas","zip":"77479","country":"United States","geoPoint":{"lat":29.61968,"lon":-95.63495}},{"facility":"GSK Investigational Site","city":"Sugarland","state":"Texas","zip":"77479","country":"United States"},{"facility":"GSK Investigational Site","city":"Bountiful","state":"Utah","zip":"84010","country":"United States","geoPoint":{"lat":40.88939,"lon":-111.88077}},{"facility":"GSK Investigational Site","city":"Murray","state":"Utah","zip":"84123","country":"United States","geoPoint":{"lat":40.66689,"lon":-111.88799}},{"facility":"GSK Investigational Site","city":"Orem","state":"Utah","zip":"84058","country":"United States","geoPoint":{"lat":40.2969,"lon":-111.69465}},{"facility":"GSK Investigational Site","city":"Salt Lake City","state":"Utah","zip":"84120","country":"United States","geoPoint":{"lat":40.76078,"lon":-111.89105}},{"facility":"GSK Investigational Site","city":"West Jordan","state":"Utah","zip":"84088","country":"United States","geoPoint":{"lat":40.60967,"lon":-111.9391}},{"facility":"GSK Investigational Site","city":"West Valley City","state":"Utah","zip":"84120","country":"United States","geoPoint":{"lat":40.69161,"lon":-112.00105}},{"facility":"GSK Investigational Site","city":"South Burlington","state":"Vermont","zip":"05403","country":"United States","geoPoint":{"lat":44.46699,"lon":-73.17096}},{"facility":"GSK Investigational Site","city":"Burke","state":"Virginia","zip":"22015","country":"United States","geoPoint":{"lat":38.79345,"lon":-77.27165}},{"facility":"GSK Investigational Site","city":"Hampton","state":"Virginia","zip":"23666","country":"United States","geoPoint":{"lat":37.02987,"lon":-76.34522}},{"facility":"GSK Investigational Site","city":"Manassas","state":"Virginia","zip":"20110","country":"United States","geoPoint":{"lat":38.75095,"lon":-77.47527}},{"facility":"GSK Investigational Site","city":"Richmond","state":"Virginia","zip":"23294","country":"United States","geoPoint":{"lat":37.55376,"lon":-77.46026}},{"facility":"GSK Investigational Site","city":"Suffolk","state":"Virginia","zip":"23434","country":"United States","geoPoint":{"lat":36.72836,"lon":-76.58496}},{"facility":"GSK Investigational Site","city":"Weber City","state":"Virginia","zip":"24290","country":"United States","geoPoint":{"lat":37.75514,"lon":-78.28389}},{"facility":"GSK Investigational Site","city":"Renton","state":"Washington","zip":"98057","country":"United States","geoPoint":{"lat":47.48288,"lon":-122.21707}},{"facility":"GSK Investigational Site","city":"Richland","state":"Washington","zip":"99352","country":"United States","geoPoint":{"lat":46.28569,"lon":-119.28446}},{"facility":"GSK Investigational Site","city":"Selah","state":"Washington","zip":"98942","country":"United States","geoPoint":{"lat":46.65402,"lon":-120.53007}},{"facility":"GSK Investigational Site","city":"Spokane","state":"Washington","zip":"99208","country":"United States","geoPoint":{"lat":47.65966,"lon":-117.42908}},{"facility":"GSK Investigational Site","city":"Spokane","state":"Washington","zip":"99216","country":"United States","geoPoint":{"lat":47.65966,"lon":-117.42908}},{"facility":"GSK Investigational Site","city":"Tacoma","state":"Washington","zip":"98405","country":"United States","geoPoint":{"lat":47.25288,"lon":-122.44429}},{"facility":"GSK Investigational Site","city":"Lewisburg","state":"West Virginia","zip":"24901","country":"United States","geoPoint":{"lat":37.80179,"lon":-80.44563}},{"facility":"GSK Investigational Site","city":"Milwaukee","state":"Wisconsin","zip":"53226","country":"United States","geoPoint":{"lat":43.0389,"lon":-87.90647}},{"facility":"GSK Investigational Site","city":"Arkhangelsk","zip":"163045","country":"Russia","geoPoint":{"lat":64.5461,"lon":40.55183}},{"facility":"GSK Investigational Site","city":"Irkutsk","zip":"664003","country":"Russia","geoPoint":{"lat":52.29566,"lon":104.29076}},{"facility":"GSK Investigational Site","city":"Nizhny Novgorod","zip":"603126","country":"Russia","geoPoint":{"lat":56.32867,"lon":44.00205}},{"facility":"GSK Investigational Site","city":"Saratov","zip":"410030","country":"Russia","geoPoint":{"lat":51.54048,"lon":45.9901}},{"facility":"GSK Investigational Site","city":"Smolensk","zip":"214019","country":"Russia","geoPoint":{"lat":54.77826,"lon":32.05088}},{"facility":"GSK Investigational Site","city":"Yaroslavl","zip":"150062","country":"Russia","geoPoint":{"lat":57.62987,"lon":39.87368}},{"facility":"GSK Investigational Site","city":"Port Elizabeth","state":"Eastern Cape","zip":"6014","country":"South Africa","geoPoint":{"lat":-33.96109,"lon":25.61494}},{"facility":"GSK Investigational Site","city":"Johannesburg","state":"Gauteng","zip":"01820","country":"South Africa","geoPoint":{"lat":-26.20227,"lon":28.04363}},{"facility":"GSK Investigational Site","city":"Johannesburg","state":"Gauteng","zip":"2013","country":"South Africa","geoPoint":{"lat":-26.20227,"lon":28.04363}},{"facility":"GSK Investigational Site","city":"Lenasia","state":"Gauteng","zip":"1827","country":"South Africa","geoPoint":{"lat":-26.32052,"lon":27.83564}},{"facility":"GSK Investigational Site","city":"Parktown","state":"Gauteng","zip":"2193","country":"South Africa","geoPoint":{"lat":-26.18205,"lon":28.02671}},{"facility":"GSK Investigational Site","city":"Pretoria","state":"Gauteng","zip":"00083","country":"South Africa","geoPoint":{"lat":-25.74486,"lon":28.18783}},{"facility":"GSK Investigational Site","city":"Phoenix","state":"KwaZulu-Natal","zip":"4068","country":"South Africa","geoPoint":{"lat":-29.70306,"lon":31.0051}},{"facility":"GSK Investigational Site","city":"Somerset West","state":"Western Province","zip":"7129","country":"South Africa","geoPoint":{"lat":-34.08401,"lon":18.82113}},{"facility":"GSK Investigational Site","city":"Cape Town","zip":"7530","country":"South Africa","geoPoint":{"lat":-33.92584,"lon":18.42322}},{"facility":"GSK Investigational Site","city":"Kempton Park","zip":"1619","country":"South Africa","geoPoint":{"lat":-26.10859,"lon":28.2377}},{"facility":"GSK Investigational Site","city":"Parow","zip":"7505","country":"South Africa","geoPoint":{"lat":-33.89723,"lon":18.59992}},{"facility":"GSK Investigational Site","city":"Blackpool","state":"Lancashire","zip":"FY4 3AD","country":"United Kingdom","geoPoint":{"lat":53.81667,"lon":-3.05}},{"facility":"GSK Investigational Site","city":"Sunbury-on-Thames","state":"Middlesex","zip":"TW16 6RH","country":"United Kingdom","geoPoint":{"lat":51.40424,"lon":-0.41817}},{"facility":"GSK Investigational Site","city":"Port Glasgow","state":"Renfrewshire","zip":"PA14 6HW","country":"United Kingdom","geoPoint":{"lat":55.93464,"lon":-4.6895}},{"facility":"GSK Investigational Site","city":"Coventry","state":"West Midlands","zip":"CV2 2DX","country":"United Kingdom","geoPoint":{"lat":52.40656,"lon":-1.51217}},{"facility":"GSK Investigational Site","city":"Liverpool","zip":"L9 7AL","country":"United Kingdom","geoPoint":{"lat":53.41058,"lon":-2.97794}},{"facility":"GSK Investigational Site","city":"London","zip":"SE1 9NH","country":"United Kingdom","geoPoint":{"lat":51.50853,"lon":-0.12574}}]},"referencesModule":{"references":[{"pmid":"28683300","type":"DERIVED","citation":"Home PD, Ahren B, Reusch JEB, Rendell M, Weissman PN, Cirkel DT, Miller D, Ambery P, Carr MC, Nauck MA. Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy. Diabetes Res Clin Pract. 2017 Sep;131:49-60. doi: 10.1016/j.diabres.2017.06.013. Epub 2017 Jun 15."},{"pmid":"25387217","type":"DERIVED","citation":"Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836."},{"pmid":"25208756","type":"DERIVED","citation":"Weissman PN, Carr MC, Ye J, Cirkel DT, Stewart M, Perry C, Pratley R. HARMONY 4: randomised clinical trial comparing once-weekly albiglutide and insulin glargine in patients with type 2 diabetes inadequately controlled with metformin with or without sulfonylurea. Diabetologia. 2014 Dec;57(12):2475-84. doi: 10.1007/s00125-014-3360-3. Epub 2014 Sep 11."},{"pmid":"24918790","type":"DERIVED","citation":"Young MA, Wald JA, Matthews JE, Yang F, Reinhardt RR. Effect of renal impairment on the pharmacokinetics, efficacy, and safety of albiglutide. Postgrad Med. 2014 May;126(3):35-46. doi: 10.3810/pgm.2014.05.2754."}],"seeAlsoLinks":[{"label":"Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.","url":"https://www.clinicalstudydatarequest.com"}],"availIpds":[{"id":"112754","type":"Individual Participant Data Set","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"112754","type":"Study Protocol","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"112754","type":"Dataset Specification","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"112754","type":"Annotated Case Report Form","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"112754","type":"Informed Consent Form","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"112754","type":"Clinical Study Report","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"},{"id":"112754","type":"Statistical Analysis Plan","url":"https://www.clinicalstudydatarequest.com","comment":"For additional information about this study please refer to the GSK Clinical Study Register"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site."}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants (par.) who met eligibility criteria and completed a 4 week Run-in/Stabilization Period were then randomized to a 156-week Treatment Period, followed by 8 weeks of post-treatment follow-up. A total of 1060 par. were screened; 779 par. were randomized, and 745 par. received \\>=1 treatment dose.","groups":[{"id":"FG000","title":"Albiglutide 30 mg + Metformin +/- Sulfonylurea","description":"Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."},{"id":"FG001","title":"Insulin Glargine 10 Units + Metformin +/- Sulfonylurea","description":"Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."}],"periods":[{"title":"Treatment Period (156 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"504"},{"groupId":"FG001","numSubjects":"241"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"308"},{"groupId":"FG001","numSubjects":"164"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"196"},{"groupId":"FG001","numSubjects":"77"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"11"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Noncompliance","reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"14"}]},{"type":"Severe or Repeated Hypoglycaemia","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"18"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"81"},{"groupId":"FG001","numSubjects":"29"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Termination of Study/Site by GSK","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Missing","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Follow-up Period (8 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"Participants withdrawing from the Treatment Period entered the Follow-up Period.","numSubjects":"504"},{"groupId":"FG001","comment":"Participants withdrawing from the Treatment Period entered the Follow-up Period.","numSubjects":"241"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"408"},{"groupId":"FG001","numSubjects":"190"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"96"},{"groupId":"FG001","numSubjects":"51"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Noncompliance","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"22"}]},{"type":"Did not Enter Follow-up Period","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"Withdrawn from Follow-up Participation","reasons":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"12"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Termination of Study/Site by GSK","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Missing","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Albiglutide 30 mg + Metformin +/- Sulfonylurea","description":"Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."},{"id":"BG001","title":"Insulin Glargine 10 Units + Metformin +/- Sulfonylurea","description":"Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"504"},{"groupId":"BG001","value":"241"},{"groupId":"BG002","value":"745"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"55.8","spread":"9.33"},{"groupId":"BG001","value":"54.7","spread":"9.75"},{"groupId":"BG002","value":"55.5","spread":"9.48"}]}]}]},{"title":"Gender","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"218"},{"groupId":"BG001","value":"109"},{"groupId":"BG002","value":"327"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"286"},{"groupId":"BG001","value":"132"},{"groupId":"BG002","value":"418"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"African American/African Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"130"},{"groupId":"BG001","value":"64"},{"groupId":"BG002","value":"194"}]}]},{"title":"American Indian or Alaskan Native","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"}]}]},{"title":"Asian - Central/South Asian Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"12"}]}]},{"title":"Asian - East Asian Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]}]},{"title":"Asian - Japanese Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]},{"title":"Asian - South East Asian Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"24"}]}]},{"title":"Native Hawaiian or Other Pacific Islander","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}]},{"title":"White - Arabic/North African Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"9"}]}]},{"title":"White - White/Caucasian/European Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"342"},{"groupId":"BG001","value":"158"},{"groupId":"BG002","value":"500"}]}]},{"title":"Other - Central American Indian","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}]},{"title":"Other - Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]},{"title":"Other - Mexican","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","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 + current antidiabetic therapy. Difference of least squares means (albiglutide - insulin glargine) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline 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.","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":"Albiglutide 30 mg + Metformin +/- Sulfonylurea","description":"Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."},{"id":"OG001","title":"Insulin Glargine 10 Units + Metformin +/- Sulfonylurea","description":"Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"493"},{"groupId":"OG001","value":"238"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.67","spread":"0.044"},{"groupId":"OG001","value":"-0.79","spread":"0.064"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.04","ciUpperLimit":"0.27"},{"groupIds":["OG000","OG001"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"To test whether the difference of least square means (albiglutide - insulin glargine) is equal to the pre-specified non-inferiority margin of 0.3%","pValue":"0.0086","pValueComment":"p-value is for non-inferiority testing of albiglutide versus insulin glargine","statisticalMethod":"t-test, 1 sided"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1463","pValueComment":"p-value is for superiority testing of albiglutide versus insulin glargine","statisticalMethod":"t-test, 2 sided","statisticalComment":"The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - insulin glargine) is equal to zero."}]},{"type":"SECONDARY","title":"Change From Baseline in HbA1c at 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. 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 par. with a value at Baseline and at the specified visit were analyzed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c in the blood","timeFrame":"Baseline and Week 156","groups":[{"id":"OG000","title":"Albiglutide 30 mg + Metformin +/- Sulfonylurea","description":"Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."},{"id":"OG001","title":"Insulin Glargine 10 Units + Metformin +/- Sulfonylurea","description":"Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"88"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.83","spread":"0.980"},{"groupId":"OG001","value":"-1.00","spread":"0.922"}]}]}]},{"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 + current antidiabetic therapy.","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":"Albiglutide 30 mg + Metformin +/- Sulfonylurea","description":"Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."},{"id":"OG001","title":"Insulin Glargine 10 Units + Metformin +/- Sulfonylurea","description":"Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"494"},{"groupId":"OG001","value":"238"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.87","spread":"0.127"},{"groupId":"OG001","value":"-2.06","spread":"0.184"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Plasma Glucose (FPG) at 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.","populationDescription":"ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimoles per liter (mmol/L)","timeFrame":"Baseline and Week 156","groups":[{"id":"OG000","title":"Albiglutide 30 mg + Metformin +/- Sulfonylurea","description":"Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."},{"id":"OG001","title":"Insulin Glargine 10 Units + Metformin +/- Sulfonylurea","description":"Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"86"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.83","spread":"2.803"},{"groupId":"OG001","value":"-2.19","spread":"3.420"}]}]}]},{"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 achieved the HbA1c treatment goal (i.e., HbA1c response levels of \\<6.5%, \\<7%, and \\<7.5% at Week 52) were assessed.","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":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Albiglutide 30 mg + Metformin +/- Sulfonylurea","description":"Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."},{"id":"OG001","title":"Insulin Glargine 10 Units + Metformin +/- Sulfonylurea","description":"Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"493"},{"groupId":"OG001","value":"238"}]}],"classes":[{"title":"HbA1c <6.5%","categories":[{"measurements":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"25"}]}]},{"title":"HbA1c <7%","categories":[{"measurements":[{"groupId":"OG000","value":"156"},{"groupId":"OG001","value":"78"}]}]},{"title":"HbA1c <7.5%","categories":[{"measurements":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"135"}]}]}]},{"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 achieved the HbA1c treatment goal (i.e., HbA1c response levels of \\<6.5%, \\<7%, and \\<7.5% at Week 156) were assessed.","populationDescription":"ITT Population with observed values. Only those par. 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":"Albiglutide 30 mg + Metformin +/- Sulfonylurea","description":"Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."},{"id":"OG001","title":"Insulin Glargine 10 Units + Metformin +/- Sulfonylurea","description":"Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"88"}]}],"classes":[{"title":"HbA1c <6.5%","categories":[{"measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"18"}]}]},{"title":"HbA1c <7%","categories":[{"measurements":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"46"}]}]},{"title":"HbA1c <7.5%","categories":[{"measurements":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"71"}]}]}]},{"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 \\<Week 4; FPG \\>=250 mg/dL between \\>=Week 4 and \\<Week 12; HbA1c \\>=8.5% and a \\<=0.5% reduction from Baseline between \\>=Week 12 and \\<Week 24; HbA1c \\>=8.5% between \\>=Week 24 and \\<Week 48; HbA1c \\>=8.0% between \\>= Week 48 and \\<Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.","populationDescription":"ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Weeks","timeFrame":"From the start of study medication until the end of the treatment (up to Week 156)","groups":[{"id":"OG000","title":"Albiglutide 30 mg + Metformin +/- Sulfonylurea","description":"Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."},{"id":"OG001","title":"Insulin Glargine 10 Units + Metformin +/- Sulfonylurea","description":"Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"496"},{"groupId":"OG001","value":"239"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"107.57","lowerLimit":"96.43","upperLimit":"143.43"},{"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."}]}]}]},{"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 prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.","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":"Albiglutide 30 mg + Metformin +/- Sulfonylurea","description":"Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."},{"id":"OG001","title":"Insulin Glargine 10 Units + Metformin +/- Sulfonylurea","description":"Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"495"},{"groupId":"OG001","value":"238"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.05","spread":"0.171"},{"groupId":"OG001","value":"1.56","spread":"0.247"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight at 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.","populationDescription":"ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms","timeFrame":"Baseline and Week 156","groups":[{"id":"OG000","title":"Albiglutide 30 mg + Metformin +/- Sulfonylurea","description":"Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."},{"id":"OG001","title":"Insulin Glargine 10 Units + Metformin +/- Sulfonylurea","description":"Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"89"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.47","spread":"6.300"},{"groupId":"OG001","value":"0.90","spread":"4.890"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52","description":"A 24-hour glucose profile was collected at Baseline and Week 52 at a subset of sites in a subset of participants per treatment group using the continuous glucose monitoring device. Glucose measurements were obtained at 5 minute increments in the 24-hour period. The area under the curve (AUC) was determined using the trapezoidal method on the measurements obtained during the first 24 hours of continuous monitoring. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. The Baseline value is the last non-missing value before the start of treatment.","populationDescription":"Glucose Profile Substudy Population: all participants who participated in the 24-hour glucose profile substudy . Only those participants with a value at Baseline and Week 52 were analyzed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimoles per hour per liter (mmol.h/L)","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Albiglutide 30 mg + Metformin +/- Sulfonylurea","description":"Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."},{"id":"OG001","title":"Insulin Glargine 10 Units + Metformin +/- Sulfonylurea","description":"Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"9"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.457","spread":"2.9898"},{"groupId":"OG001","value":"-1.657","spread":"1.9453"}]}]}]},{"type":"SECONDARY","title":"Albiglutide Plasma Concentrations at Week 8 and Week 24","description":"Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post-dose, Week 24 pre-dose and Week 24 post-dose. All participants receiving albiglutide were initiated on a 30 mg weekly dosing regimen; however, beginning at Week 4, uptitration of albiglutide was allowed based on glycemic response. As such, albiglutide plasma concentrations achieved at each sampling time represent a mixed population of participants receiving either 30 mg or 50 mg weekly for various durations.","populationDescription":"ITT population. Only those participants with a PK sample available for analysis at the indicated time points were analyzed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"nanograms/milliliter (ng/mL)","timeFrame":"Weeks 8 and 24","groups":[{"id":"OG000","title":"Albiglutide 30 mg + Metformin +/- Sulfonylurea","description":"Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"459"}]}],"classes":[{"title":"Week 8, Pre-dose, n=408","categories":[{"measurements":[{"groupId":"OG000","value":"1642.83","spread":"892.570"}]}]},{"title":"Week 8, Post-dose, n=398","categories":[{"measurements":[{"groupId":"OG000","value":"1911.35","spread":"966.180"}]}]},{"title":"Week 24, Pre-dose, n=416","categories":[{"measurements":[{"groupId":"OG000","value":"2159.30","spread":"1211.714"}]}]},{"title":"Week 24, Post-dose, n=401","categories":[{"measurements":[{"groupId":"OG000","value":"2748.15","spread":"1503.945"}]}]}]}]},"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":"Albiglutide 30 mg + Metformin +/- Sulfonylurea","description":"Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.","seriousNumAffected":92,"seriousNumAtRisk":504,"otherNumAffected":429,"otherNumAtRisk":504},{"id":"EG001","title":"Insulin Glargine 10 Units + Metformin +/- Sulfonylurea","description":"Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \\>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.","seriousNumAffected":46,"seriousNumAtRisk":241,"otherNumAffected":199,"otherNumAtRisk":241}],"seriousEvents":[{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Bronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":2,"numAtRisk":241}]},{"term":"Osteomyelitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Diverticulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":2,"numAtRisk":241}]},{"term":"Lobar pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":2,"numAtRisk":241}]},{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Arthritis bacterial","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Bacterial pyelonephritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Bronchopneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Epiglottitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Eye abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Gangrene","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Hepatitis B","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Localised infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Perirectal abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Pyelonephritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Staphylococcal infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Tracheobronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":504},{"groupId":"EG001","numAffected":2,"numAtRisk":241}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":504},{"groupId":"EG001","numAffected":2,"numAtRisk":241}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":504},{"groupId":"EG001","numAffected":3,"numAtRisk":241}]},{"term":"Cardiac failure congestive","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":504},{"groupId":"EG001","numAffected":2,"numAtRisk":241}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Acute coronary syndrome","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Angina pectoris","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Arteriosclerosis coronary artery","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Atrial flutter","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Bradycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Cardiomyopathy","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Conduction disorder","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Coronary artery insufficiency","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Sinus bradycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Ventricular tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":504},{"groupId":"EG001","numAffected":4,"numAtRisk":241}]},{"term":"Non-cardiac chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Death","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Device leakage","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Generalised oedema","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Sudden cardiac death","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":504},{"groupId":"EG001","numAffected":3,"numAtRisk":241}]},{"term":"Arthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":2,"numAtRisk":241}]},{"term":"Cervical spinal stenosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Intervertebral disc protrusion","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Bursitis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Neuropathic arthropathy","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Pathological fracture","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Periarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Rotator cuff syndrome","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Spondylolisthesis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Acute myeloid leukaemia","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Breast cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Endometrial cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Lung adenocarcinoma metastatic","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Lung neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Lung neoplasm malignant","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Lung squamous cell carcinoma stage unspecified","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Meningioma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Myelodysplastic syndrome","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Oesophageal carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Prostate cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Sarcoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Lower gastrointestinal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Abdominal hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Ascites","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Gastrointestinal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Gastrooesophageal reflux disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Haemorrhoids","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Pancreatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Peptic ulcer","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Umbilical hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Arterial injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Femur fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Gastroenteritis radiation","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Heat stroke","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Hip fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Meniscus lesion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Road traffic accident","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Seroma","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Skeletal injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Toxicity to various agents","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Wound dehiscence","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Asthma","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Acute respiratory failure","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Bronchospasm","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Chronic obstructive pulmonary disease","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Dyspnoea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Pneumothorax","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Pulmonary embolism","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Pulmonary hypertension","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Calculus urinary","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Hydronephrosis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Nephrolithiasis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Renal failure acute","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Calculus ureteric","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Cerebrovascular accident","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Transient ischaemic attack","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Migraine","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Neuropathy peripheral","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Syncope","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Deep vein thrombosis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Diabetic vascular disorder","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Haematoma","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Haemorrhage","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Hypotension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Peripheral ischaemia","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Peripheral vascular disorder","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Cholecystitis Acute","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":3,"numAtRisk":241}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Hepatitis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Idiopathic thrombocytopenic purpura","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Iron deficiency anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Confusional state","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Schizophrenia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Hypoglycaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":2,"numAtRisk":241}]},{"term":"Cataract","organSystem":"Eye disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Retinal detachment","organSystem":"Eye disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Dysfunctional uterine bleeding","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Menorrhagia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Anaphylactic reaction","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Diabetic foot","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]}],"otherEvents":[{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":83,"numAtRisk":504},{"groupId":"EG001","numAffected":37,"numAtRisk":241}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":504},{"groupId":"EG001","numAffected":24,"numAtRisk":241}]},{"term":"Sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":504},{"groupId":"EG001","numAffected":23,"numAtRisk":241}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":504},{"groupId":"EG001","numAffected":21,"numAtRisk":241}]},{"term":"Bronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":504},{"groupId":"EG001","numAffected":27,"numAtRisk":241}]},{"term":"Influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":504},{"groupId":"EG001","numAffected":22,"numAtRisk":241}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":504},{"groupId":"EG001","numAffected":6,"numAtRisk":241}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":504},{"groupId":"EG001","numAffected":7,"numAtRisk":241}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":504},{"groupId":"EG001","numAffected":5,"numAtRisk":241}]},{"term":"Onychomycosis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":504},{"groupId":"EG001","numAffected":2,"numAtRisk":241}]},{"term":"Tooth abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":504},{"groupId":"EG001","numAffected":4,"numAtRisk":241}]},{"term":"Tinea pedis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Pharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":504},{"groupId":"EG001","numAffected":6,"numAtRisk":241}]},{"term":"Cystitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":504},{"groupId":"EG001","numAffected":5,"numAtRisk":241}]},{"term":"Hypoglycaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":187,"numAtRisk":504},{"groupId":"EG001","numAffected":117,"numAtRisk":241}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":504},{"groupId":"EG001","numAffected":4,"numAtRisk":241}]},{"term":"Dyslipidaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":504},{"groupId":"EG001","numAffected":7,"numAtRisk":241}]},{"term":"Arthralgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":504},{"groupId":"EG001","numAffected":17,"numAtRisk":241}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":504},{"groupId":"EG001","numAffected":20,"numAtRisk":241}]},{"term":"Pain in extremity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":504},{"groupId":"EG001","numAffected":17,"numAtRisk":241}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":504},{"groupId":"EG001","numAffected":9,"numAtRisk":241}]},{"term":"Muscle spasms","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":504},{"groupId":"EG001","numAffected":6,"numAtRisk":241}]},{"term":"Musculoskeletal pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":504},{"groupId":"EG001","numAffected":19,"numAtRisk":241}]},{"term":"Arthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":504},{"groupId":"EG001","numAffected":2,"numAtRisk":241}]},{"term":"Myalgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":504},{"groupId":"EG001","numAffected":6,"numAtRisk":241}]},{"term":"Rotator cuff syndrome","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":504},{"groupId":"EG001","numAffected":6,"numAtRisk":241}]},{"term":"Spinal osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":504},{"groupId":"EG001","numAffected":5,"numAtRisk":241}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":67,"numAtRisk":504},{"groupId":"EG001","numAffected":18,"numAtRisk":241}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":504},{"groupId":"EG001","numAffected":19,"numAtRisk":241}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":504},{"groupId":"EG001","numAffected":4,"numAtRisk":241}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":504},{"groupId":"EG001","numAffected":13,"numAtRisk":241}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":504},{"groupId":"EG001","numAffected":7,"numAtRisk":241}]},{"term":"Gastrooesophageal reflux disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":504},{"groupId":"EG001","numAffected":6,"numAtRisk":241}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":504},{"groupId":"EG001","numAffected":8,"numAtRisk":241}]},{"term":"Toothache","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":504},{"groupId":"EG001","numAffected":5,"numAtRisk":241}]},{"term":"Injection site reaction","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":504},{"groupId":"EG001","numAffected":8,"numAtRisk":241}]},{"term":"Oedema peripheral","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":504},{"groupId":"EG001","numAffected":15,"numAtRisk":241}]},{"term":"Injection site haematoma","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":504},{"groupId":"EG001","numAffected":20,"numAtRisk":241}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":504},{"groupId":"EG001","numAffected":3,"numAtRisk":241}]},{"term":"Injection site erythema","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":504},{"groupId":"EG001","numAffected":0,"numAtRisk":241}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":504},{"groupId":"EG001","numAffected":8,"numAtRisk":241}]},{"term":"Pyrexia","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":504},{"groupId":"EG001","numAffected":7,"numAtRisk":241}]},{"term":"Pain","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":504},{"groupId":"EG001","numAffected":6,"numAtRisk":241}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":504},{"groupId":"EG001","numAffected":20,"numAtRisk":241}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":504},{"groupId":"EG001","numAffected":8,"numAtRisk":241}]},{"term":"Diabetic neuropathy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":504},{"groupId":"EG001","numAffected":15,"numAtRisk":241}]},{"term":"Carpal tunnel syndrome","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":504},{"groupId":"EG001","numAffected":6,"numAtRisk":241}]},{"term":"Cough","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":504},{"groupId":"EG001","numAffected":29,"numAtRisk":241}]},{"term":"Oropharyngeal pain","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":504},{"groupId":"EG001","numAffected":7,"numAtRisk":241}]},{"term":"Asthma","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":504},{"groupId":"EG001","numAffected":5,"numAtRisk":241}]},{"term":"Nasal congestion","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":504},{"groupId":"EG001","numAffected":1,"numAtRisk":241}]},{"term":"Sinus congestion","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":504},{"groupId":"EG001","numAffected":7,"numAtRisk":241}]},{"term":"Dyspnoea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":504},{"groupId":"EG001","numAffected":10,"numAtRisk":241}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":67,"numAtRisk":504},{"groupId":"EG001","numAffected":29,"numAtRisk":241}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":504},{"groupId":"EG001","numAffected":13,"numAtRisk":241}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":504},{"groupId":"EG001","numAffected":7,"numAtRisk":241}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":504},{"groupId":"EG001","numAffected":13,"numAtRisk":241}]},{"term":"Cataract","organSystem":"Eye disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":504},{"groupId":"EG001","numAffected":13,"numAtRisk":241}]},{"term":"Diabetic retinopathy","organSystem":"Eye disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":504},{"groupId":"EG001","numAffected":10,"numAtRisk":241}]},{"term":"Rash","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":504},{"groupId":"EG001","numAffected":10,"numAtRisk":241}]},{"term":"Dermatitis contact","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":504},{"groupId":"EG001","numAffected":5,"numAtRisk":241}]},{"term":"Hyperkeratosis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":504},{"groupId":"EG001","numAffected":5,"numAtRisk":241}]},{"term":"Muscle strain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":504},{"groupId":"EG001","numAffected":8,"numAtRisk":241}]},{"term":"Ligament sprain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":504},{"groupId":"EG001","numAffected":5,"numAtRisk":241}]},{"term":"Contusion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":504},{"groupId":"EG001","numAffected":9,"numAtRisk":241}]},{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":504},{"groupId":"EG001","numAffected":12,"numAtRisk":241}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":504},{"groupId":"EG001","numAffected":6,"numAtRisk":241}]},{"term":"Seasonal allergy","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":504},{"groupId":"EG001","numAffected":6,"numAtRisk":241}]},{"term":"Weight increased","organSystem":"Investigations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":504},{"groupId":"EG001","numAffected":5,"numAtRisk":241}]},{"term":"Palpitations","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":504},{"groupId":"EG001","numAffected":5,"numAtRisk":241}]},{"term":"Basal cell carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":504},{"groupId":"EG001","numAffected":5,"numAtRisk":241}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial."},"pointOfContact":{"title":"GSK Response Center","organization":"GlaxoSmithKline","phone":"866-435-7343"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09","removedCountries":["Argentina","France"]},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"},{"id":"D003920","term":"Diabetes Mellitus"}],"ancestors":[{"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":"C534611","term":"rGLP-1 protein"},{"id":"D000069036","term":"Insulin Glargine"}],"ancestors":[{"id":"D049528","term":"Insulin, Long-Acting"},{"id":"D061385","term":"Insulins"},{"id":"D010187","term":"Pancreatic Hormones"},{"id":"D036361","term":"Peptide Hormones"},{"id":"D006728","term":"Hormones"},{"id":"D006730","term":"Hormones, Hormone Substitutes, and Hormone Antagonists"},{"id":"D010455","term":"Peptides"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"}]}},"hasResults":true}