{"protocolSection":{"identificationModule":{"nctId":"NCT00763815","orgStudyIdInfo":{"id":"EFC6017"},"secondaryIdInfos":[{"id":"EudraCT: 2007-005884-92"}],"organization":{"fullName":"Sanofi","class":"INDUSTRY"},"briefTitle":"GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone","officialTitle":"A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Pioglitazone in Patients With Type 2 Diabetes Not Adequately Controlled With Pioglitazone","acronym":"GETGOAL-P"},"statusModule":{"statusVerifiedDate":"2016-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-09"},"primaryCompletionDateStruct":{"date":"2011-06","type":"ACTUAL"},"completionDateStruct":{"date":"2011-06","type":"ACTUAL"},"studyFirstSubmitDate":"2008-09-30","studyFirstSubmitQcDate":"2008-09-30","studyFirstPostDateStruct":{"date":"2008-10-01","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-08-18","resultsFirstSubmitQcDate":"2016-08-18","resultsFirstPostDateStruct":{"date":"2016-10-11","type":"ESTIMATED"},"dispFirstSubmitDate":"2012-05-07","dispFirstSubmitQcDate":"2012-05-07","dispFirstPostDateStruct":{"date":"2012-05-10","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-10-14","lastUpdatePostDateStruct":{"date":"2016-11-28","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Sanofi","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension.\n\nThe primary objective is to assess the effects of lixisenatide when added to pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.\n\nSecondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function \\[HOMA-beta\\]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.","detailedDescription":"Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the schedule date of Week 76 visit (Visit 25) for the last randomized patients."},"conditionsModule":{"conditions":["Diabetes Mellitus Type 2"],"keywords":["hyperglycemia GLP-1 pioglitazone"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":484,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Lixisenatide","type":"EXPERIMENTAL","description":"2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.","interventionNames":["Drug: Lixisenatide (AVE0010)","Device: Pen auto-injector","Drug: Pioglitazone","Drug: Metformin"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.","interventionNames":["Drug: Placebo","Device: Pen auto-injector","Drug: Pioglitazone","Drug: Metformin"]}],"interventions":[{"type":"DRUG","name":"Lixisenatide (AVE0010)","description":"Self-administered by subcutaneous injections once daily within the hour preceding breakfast.","armGroupLabels":["Lixisenatide"]},{"type":"DRUG","name":"Placebo","description":"Self-administered by subcutaneous injections once daily within the hour preceding breakfast.","armGroupLabels":["Placebo"]},{"type":"DEVICE","name":"Pen auto-injector","armGroupLabels":["Lixisenatide","Placebo"],"otherNames":["OptiClik®"]},{"type":"DRUG","name":"Pioglitazone","description":"Dose to be kept stable.","armGroupLabels":["Lixisenatide","Placebo"]},{"type":"DRUG","name":"Metformin","description":"Metformin, if given to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.","armGroupLabels":["Lixisenatide","Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24","description":"Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline, Week 24"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24","description":"Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline, Week 24"},{"measure":"Change From Baseline in Body Weight at Week 24","description":"Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline, Week 24"},{"measure":"Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24","description":"Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline, Week 24"},{"measure":"Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24","description":"The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Week 24"},{"measure":"Percentage of Patients With HbA1c Level Less Than or Equal to 6.5% at Week 24","description":"The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Week 24"},{"measure":"Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24","description":"Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin \\[micro unit per milliliter\\]) divided by (fasting plasma glucose \\[mmol/L\\] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline, Week 24"},{"measure":"Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period","description":"Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG \\>270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG \\>240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG \\>200 mg/dL (11.1 mmol/L) or HbA1c \\>8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline up to Week 24"}],"otherOutcomes":[{"measure":"Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24","description":"The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline, Week 24"},{"measure":"Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia","description":"Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.","timeFrame":"First dose of study drug up to 3 days after the last dose administration, for up to 132 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Type 2 diabetes mellitus, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with pioglitazone\n\nExclusion Criteria:\n\n* HbA1c less than (\\<) 7 percent (%) or greater than (\\>) 10% at screening\n* At the time of screening age \\<legal age of majority\n* Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control\n* Type 1 diabetes mellitus\n* Pioglitazone not at a stable dose of at least 30 milligram per day (mg/day) for at least 3 months prior to screening\n* If treatment with metformin, no stable dose of at least 1.5 gram per day (g/day) for at least 3 months prior to screening visit\n* FPG at screening \\>250 milligram per deciliter (mg/dL) (\\>13.9 millimole per liter \\[mmol/L\\])\n* Body mass index less than or equal to (\\<=) 20 kilogram per square meter (kg/m\\^2)\n* Weight change of more than 5 kg during the 3 months preceding the screening visit\n* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, or inflammatory bowel disease\n* History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening\n* Hemoglobinopathy or hemolytic anemia, or receipt of blood or plasma products within3 months prior to the time of screening\n* History of myocardial infarction or stroke within the last 6 months prior to screening\n* Known history of drug or alcohol abuse within 6 months prior to the time of screening\n* Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period\n* Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure or diastolic blood pressure (DBP) \\>180 millimeter of mercury (mmHg) or \\>95 mmHg, respectively\n* Laboratory findings at the time of screening: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP): \\>2 times upper limit of normal (ULN) laboratory range; amylase and/or lipase: \\>3 times ULN; total bilirubin: \\>1.5 times ULN (except in case of Gilbert's syndrome); Hemoglobin \\<11 gram/deciliter and/or neutrophils \\<1500 per cubic millimeter (mm\\^3) and/or platelets \\<100 000/mm\\^3; positive test for Hepatitis B surface antigen (HBsAg) and/or Hepatitis C antibody (HCAb); positive serum pregnancy test in females of childbearing potential\n* Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram (ECG), or vital signs at the time of screening that, in the judgment of the investigator or any sub-investigator, precludes safe completion of the study or constrains efficacy assessment\n* Patients who are considered by the investigator or any sub-investigator as inappropriate for this study for any reason (for example, impossibility to meet specific protocol requirements \\[such as scheduled visits, being able to do self-injections\\]; likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol; investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol)\n* Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin or pioglitazone (for example, sulfonylurea, alpha-glucosidase inhibitor, other thiazolidinediones, rimonabant, exenatide, dipeptidyl peptidase-4 \\[DPP-4\\] inhibitors, insulin) within 3 months prior to the time of screening\n* Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening\n* Use of any investigational drug within 3 months prior to study\n* Any previous treatment with lixisenatide or participation in a previous study with lixisenatide\n* Renal impairment defined with creatinine \\>1.4 mg/dL in women and creatinine \\>1.5 mg/dL in men (applicable only for patients with metformin treatment)\n* Patients with cardiac failure or history of cardiac failure (New York Heart Association class I to IV)\n* End-stage renal disease defined by a serum creatinine clearance of \\<15 milliliter per minute (mL/min) (calculated by the Cockcroft and Gault formula) and/or patients on dialysis, if no treatment with metformin\n* Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to, gastroparesis and gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening\n* Allergic reaction to any glucagon like peptide-1 (GLP-1) agonist in the past (for example,exenatide, liraglutide) or to metacresol\n* Additional exclusion criteria at the end of the run-in phase: informed consent withdrawal; lack of compliance during the single-blind placebo run-in phase (\\>2 injections missed); and patient with any adverse event which precludes the inclusion in the study, as assessed by the investigator","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Sciences & Operations","affiliation":"Sanofi","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Sanofi-Aventis Investigational Site Number 840723","city":"Birmingham","state":"Alabama","zip":"35205","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Sanofi-Aventis Investigational Site Number 840744","city":"Birmingham","state":"Alabama","zip":"35205","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Sanofi-Aventis Investigational Site Number 840867","city":"Birmingham","state":"Alabama","zip":"35235","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Sanofi-Aventis Investigational Site Number 840720","city":"Birmingham","state":"Alabama","zip":"35242","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Sanofi-Aventis Investigational Site Number 840855","city":"Mobile","state":"Alabama","zip":"36608","country":"United States","geoPoint":{"lat":30.69436,"lon":-88.04305}},{"facility":"Sanofi-Aventis Investigational Site Number 840863","city":"Mobile","state":"Alabama","zip":"36608","country":"United States","geoPoint":{"lat":30.69436,"lon":-88.04305}},{"facility":"Sanofi-Aventis Investigational Site Number 840775","city":"Chandler","state":"Arizona","zip":"85224","country":"United States","geoPoint":{"lat":33.30616,"lon":-111.84125}},{"facility":"Sanofi-Aventis Investigational Site Number 840722","city":"Mesa","state":"Arizona","zip":"85213","country":"United States","geoPoint":{"lat":33.42227,"lon":-111.82264}},{"facility":"Sanofi-Aventis Investigational Site Number 840769","city":"Phoenix","state":"Arizona","zip":"85050","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Sanofi-Aventis Investigational Site Number 840729","city":"Harrisburg","state":"Arkansas","zip":"72432","country":"United States","geoPoint":{"lat":35.56425,"lon":-90.71678}},{"facility":"Sanofi-Aventis Investigational Site Number 840776","city":"Mountain Home","state":"Arkansas","zip":"72653","country":"United States","geoPoint":{"lat":36.33534,"lon":-92.38516}},{"facility":"Sanofi-Aventis Investigational Site Number 840795","city":"Artesia","state":"California","zip":"90701","country":"United States","geoPoint":{"lat":33.86585,"lon":-118.08312}},{"facility":"Sanofi-Aventis Investigational Site Number 840782","city":"Chino","state":"California","zip":"91710","country":"United States","geoPoint":{"lat":34.01223,"lon":-117.68894}},{"facility":"Sanofi-Aventis Investigational Site Number 840785","city":"Huntington Beach","state":"California","zip":"92648","country":"United States","geoPoint":{"lat":33.6603,"lon":-117.99923}},{"facility":"Sanofi-Aventis Investigational Site Number 840858","city":"La Jolla","state":"California","zip":"92037","country":"United States","geoPoint":{"lat":32.84727,"lon":-117.2742}},{"facility":"Sanofi-Aventis Investigational Site Number 840784","city":"Los Banos","state":"California","zip":"93635","country":"United States","geoPoint":{"lat":37.05828,"lon":-120.84992}},{"facility":"Sanofi-Aventis Investigational Site Number 840773","city":"Mission Hills","state":"California","zip":"91345","country":"United States","geoPoint":{"lat":34.68609,"lon":-120.43683}},{"facility":"Sanofi-Aventis Investigational Site Number 840707","city":"Mission Viejo","state":"California","zip":"92691","country":"United States","geoPoint":{"lat":33.60002,"lon":-117.672}},{"facility":"Sanofi-Aventis Investigational Site Number 840733","city":"Northridge","state":"California","zip":"91325","country":"United States","geoPoint":{"lat":34.22834,"lon":-118.53675}},{"facility":"Sanofi-Aventis Investigational Site Number 840864","city":"Roseville","state":"California","zip":"95661","country":"United States","geoPoint":{"lat":38.75212,"lon":-121.28801}},{"facility":"Sanofi-Aventis Investigational Site Number 840772","city":"San Diego","state":"California","zip":"92123","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Sanofi-Aventis Investigational Site Number 840743","city":"San Mateo","state":"California","zip":"94401","country":"United States","geoPoint":{"lat":37.56299,"lon":-122.32553}},{"facility":"Sanofi-Aventis Investigational Site Number 840721","city":"Stockton","state":"California","zip":"95204","country":"United States","geoPoint":{"lat":37.9577,"lon":-121.29078}},{"facility":"Sanofi-Aventis Investigational Site Number 840763","city":"West Hills","state":"California","zip":"91307","country":"United States","geoPoint":{"lat":34.19731,"lon":-118.64398}},{"facility":"Sanofi-Aventis Investigational Site Number 840872","city":"Colorado Springs","state":"Colorado","zip":"80907","country":"United States","geoPoint":{"lat":38.83388,"lon":-104.82136}},{"facility":"Sanofi-Aventis Investigational Site Number 840868","city":"Colorado Springs","state":"Colorado","zip":"80909","country":"United States","geoPoint":{"lat":38.83388,"lon":-104.82136}},{"facility":"Sanofi-Aventis Investigational Site Number 840727","city":"Jacksonville","state":"Florida","zip":"32216","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Sanofi-Aventis Investigational Site Number 840745","city":"New Port Richey","state":"Florida","zip":"34652","country":"United States","geoPoint":{"lat":28.24418,"lon":-82.71927}},{"facility":"Sanofi-Aventis Investigational Site Number 840761","city":"Oviedo","state":"Florida","zip":"32765","country":"United States","geoPoint":{"lat":28.67,"lon":-81.20812}},{"facility":"Sanofi-Aventis Investigational Site Number 840799","city":"Wellington","state":"Florida","zip":"33414","country":"United States","geoPoint":{"lat":26.65868,"lon":-80.24144}},{"facility":"Sanofi-Aventis Investigational Site Number 840857","city":"Augusta","state":"Georgia","zip":"30909","country":"United States","geoPoint":{"lat":33.47097,"lon":-81.97484}},{"facility":"Sanofi-Aventis Investigational Site Number 840724","city":"Idaho Falls","state":"Idaho","zip":"83404","country":"United States","geoPoint":{"lat":43.46658,"lon":-112.03414}},{"facility":"Sanofi-Aventis Investigational Site Number 840791","city":"Chicago","state":"Illinois","zip":"60611","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"Sanofi-Aventis Investigational Site Number 840738","city":"Avon","state":"Indiana","zip":"46123","country":"United States","geoPoint":{"lat":39.76282,"lon":-86.39972}},{"facility":"Sanofi-Aventis Investigational Site Number 840794","city":"Indianapolis","state":"Indiana","zip":"46260","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Sanofi-Aventis Investigational Site Number 840767","city":"Kansas City","state":"Kansas","zip":"66160-7321","country":"United States","geoPoint":{"lat":39.11417,"lon":-94.62746}},{"facility":"Sanofi-Aventis Investigational Site Number 840779","city":"Lansing","state":"Kansas","zip":"66043","country":"United States","geoPoint":{"lat":39.24861,"lon":-94.90024}},{"facility":"Sanofi-Aventis Investigational Site Number 840739","city":"Wichita","state":"Kansas","zip":"67203","country":"United States","geoPoint":{"lat":37.69224,"lon":-97.33754}},{"facility":"Sanofi-Aventis Investigational Site Number 840789","city":"Lexington","state":"Kentucky","zip":"40503","country":"United States","geoPoint":{"lat":37.98869,"lon":-84.47772}},{"facility":"Sanofi-Aventis Investigational Site Number 840850","city":"Lexington","state":"Kentucky","zip":"40504","country":"United States","geoPoint":{"lat":37.98869,"lon":-84.47772}},{"facility":"Sanofi-Aventis Investigational Site Number 840862","city":"Baton Rouge","state":"Louisiana","zip":"70808","country":"United States","geoPoint":{"lat":30.44332,"lon":-91.18747}},{"facility":"Sanofi-Aventis Investigational Site Number 840879","city":"Shreveport","state":"Louisiana","zip":"71101","country":"United States","geoPoint":{"lat":32.52515,"lon":-93.75018}},{"facility":"Sanofi-Aventis Investigational Site Number 840764","city":"Hyattsville","state":"Maryland","zip":"20783","country":"United States","geoPoint":{"lat":38.95594,"lon":-76.94553}},{"facility":"Sanofi-Aventis Investigational Site Number 840871","city":"Rockville","state":"Maryland","zip":"20850","country":"United States","geoPoint":{"lat":39.084,"lon":-77.15276}},{"facility":"Sanofi-Aventis Investigational Site Number 840851","city":"Russells Mills","state":"Massachusetts","zip":"2747","country":"United States","geoPoint":{"lat":41.57233,"lon":-71.00643}},{"facility":"Sanofi-Aventis Investigational Site Number 840708","city":"Kalamazoo","state":"Michigan","zip":"49001","country":"United States","geoPoint":{"lat":42.29171,"lon":-85.58723}},{"facility":"Sanofi-Aventis Investigational Site Number 840774","city":"Bloomington","state":"Minnesota","zip":"55435","country":"United States","geoPoint":{"lat":44.8408,"lon":-93.29828}},{"facility":"Sanofi-Aventis Investigational Site Number 840704","city":"Eagan","state":"Minnesota","zip":"55122","country":"United States","geoPoint":{"lat":44.80413,"lon":-93.16689}},{"facility":"Sanofi-Aventis Investigational Site Number 840717","city":"Picayune","state":"Mississippi","zip":"39466","country":"United States","geoPoint":{"lat":30.52556,"lon":-89.67788}},{"facility":"Sanofi-Aventis Investigational Site Number 840765","city":"St Louis","state":"Missouri","zip":"63104","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"Sanofi-Aventis Investigational Site Number 840875","city":"Las Vegas","state":"Nevada","zip":"89119","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"Sanofi-Aventis Investigational Site Number 840866","city":"Pahrump","state":"Nevada","zip":"89048","country":"United States","geoPoint":{"lat":36.20829,"lon":-115.98391}},{"facility":"Sanofi-Aventis Investigational Site Number 840865","city":"New York","state":"New York","zip":"10010","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Sanofi-Aventis Investigational Site Number 840766","city":"New York","state":"New York","zip":"10021","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Sanofi-Aventis Investigational Site Number 840874","city":"Staten Island","state":"New York","zip":"10301","country":"United 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Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). Diabetes Obes Metab. 2013 Nov;15(11):1000-7. doi: 10.1111/dom.12121. Epub 2013 May 26."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 906 patients were screened of which 422 (46.6%) were screen failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7% and less than or equal to 10%). A total of 484 patients were randomized.","recruitmentDetails":"The study was conducted at 150 centers in 13 countries between September 29, 2008 and June 29, 2011. 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HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin \\[micro unit per milliliter\\]) divided by (fasting plasma glucose \\[mmol/L\\] minus 3.5). Here, Number of patients analyzed = 141 and 300 for Placebo and Lixisenatide treatment arms, respectively.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of normal beta cells function","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36.23","spread":"26.50"},{"groupId":"BG001","value":"34.69","spread":"30.30"},{"groupId":"BG002","value":"35.18","spread":"29.12"}]}]}]},{"title":"Fasting Plasma Insulin (FPI)","description":"Here, Number of patients analyzed = 142 and 300 for Placebo and Lixisenatide treatment arms, respectively.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"picomole per liter (pmol/L)","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"66.07","spread":"48.12"},{"groupId":"BG001","value":"63.32","spread":"57.69"},{"groupId":"BG002","value":"64.21","spread":"54.76"}]}]}]},{"title":"Duration of Diabetes","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.09","spread":"5.58"},{"groupId":"BG001","value":"8.11","spread":"5.44"},{"groupId":"BG002","value":"8.10","spread":"5.48"}]}]}]},{"title":"Duration of Pioglitazone Treatment","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1.79","spread":"2.51"},{"groupId":"BG001","value":"1.69","spread":"2.00"},{"groupId":"BG002","value":"1.72","spread":"2.18"}]}]}]},{"title":"Pioglitazone Daily Dose","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":">=30 milligram (mg) to Less Than (<) 45 mg","categories":[{"measurements":[{"groupId":"BG000","value":"126"},{"groupId":"BG001","value":"242"},{"groupId":"BG002","value":"368"}]}]},{"title":">= 45 mg","categories":[{"measurements":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"81"},{"groupId":"BG002","value":"116"}]}]}]},{"title":"Metformin Use at Screening","description":"Number of patients with metformin use at baseline was reported.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"131"},{"groupId":"BG001","value":"261"},{"groupId":"BG002","value":"392"}]}]}]},{"title":"Body Mass Index (BMI)","description":"BMI was calculated by dividing body weight (kilogram) by the height (meter) squared.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kilogram per square meter (kg/m^2)","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"34.44","spread":"7.04"},{"groupId":"BG001","value":"33.66","spread":"6.71"},{"groupId":"BG002","value":"33.92","spread":"6.82"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24","description":"Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of hemoglobin","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"308"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.34","spread":"0.100"},{"groupId":"OG001","value":"-0.90","spread":"0.089"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 300 patients in lixisenatide arm and 150 patients in placebo arm would provide a power of 96% (or 86%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms; randomization strata of screening HbA1c (\\<8.0, \\>=8.0%), metformin use (yes, no); country as fixed effects; baseline HbA1c as covariate.","statisticalMethod":"ANCOVA","paramType":"Least Squares (LS) Mean Difference","paramValue":"-0.56","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.731","ciUpperLimit":"-0.386","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.088"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24","description":"Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"317"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.32","spread":"0.215"},{"groupId":"OG001","value":"-1.16","spread":"0.192"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight at Week 24","description":"Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilogram","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"157"},{"groupId":"OG001","value":"315"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.21","spread":"0.357"},{"groupId":"OG001","value":"-0.21","spread":"0.324"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24","description":"Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPI assessment during on-treatment period.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"pmol/L","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"281"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.01","spread":"4.080"},{"groupId":"OG001","value":"-10.36","spread":"3.397"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24","description":"The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"308"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26.4"},{"groupId":"OG001","value":"52.3"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients With HbA1c Level Less Than or Equal to 6.5% at Week 24","description":"The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"308"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.1"},{"groupId":"OG001","value":"28.9"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24","description":"Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin \\[micro unit per milliliter\\]) divided by (fasting plasma glucose \\[mmol/L\\] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"% of normal beta cells function","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"124"},{"groupId":"OG001","value":"281"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.98","spread":"3.575"},{"groupId":"OG001","value":"6.72","spread":"2.963"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period","description":"Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG \\>270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG \\>240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG \\>200 mg/dL (11.1 mmol/L) or HbA1c \\>8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline up to Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"320"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11.3"},{"groupId":"OG001","value":"3.8"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24","description":"The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"157"},{"groupId":"OG001","value":"315"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.1"},{"groupId":"OG001","value":"9.2"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia","description":"Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.","populationDescription":"Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"First dose of study drug up to 3 days after the last dose administration, for up to 132 weeks","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"161"},{"groupId":"OG001","value":"323"}]}],"classes":[{"title":"Symptomatic Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"23"}]}]},{"title":"Severe Symptomatic Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"First dose of study drug up to 3 days after the last dose administration, for up to 132 weeks","description":"Median exposure to study treatment was 615.5 and 588.0 days in lixisenatide and placebo treatment arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.","eventGroups":[{"id":"EG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo.","seriousNumAffected":15,"seriousNumAtRisk":161,"otherNumAffected":105,"otherNumAtRisk":161},{"id":"EG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide.","seriousNumAffected":25,"seriousNumAtRisk":323,"otherNumAffected":219,"otherNumAtRisk":323}],"seriousEvents":[{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Bronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":161},{"groupId":"EG001","numAffected":0,"numAtRisk":323}]},{"term":"Diabetic foot infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Bile duct cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":161},{"groupId":"EG001","numAffected":0,"numAtRisk":323}]},{"term":"Non-small cell lung cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Hyperglycaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":161},{"groupId":"EG001","numAffected":0,"numAtRisk":323}]},{"term":"Cerebral infarction","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Convulsion","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Memory impairment","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":161},{"groupId":"EG001","numAffected":0,"numAtRisk":323}]},{"term":"Sciatica","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Transient ischaemic attack","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Diabetic retinopathy","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Macular oedema","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Retinal detachment","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Vitreous haemorrhage","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Acute coronary syndrome","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":161},{"groupId":"EG001","numAffected":0,"numAtRisk":323}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":161},{"groupId":"EG001","numAffected":0,"numAtRisk":323}]},{"term":"Arteriosclerosis coronary artery","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Mitral valve incompetence","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":161},{"groupId":"EG001","numAffected":0,"numAtRisk":323}]},{"term":"Blue toe syndrome","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Shock haemorrhagic","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Acute respiratory failure","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Pneumonitis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":161},{"groupId":"EG001","numAffected":0,"numAtRisk":323}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":161},{"groupId":"EG001","numAffected":0,"numAtRisk":323}]},{"term":"Peritoneal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":161},{"groupId":"EG001","numAffected":1,"numAtRisk":323}]},{"term":"Umbilical 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