{"protocolSection":{"identificationModule":{"nctId":"NCT00929344","orgStudyIdInfo":{"id":"AA014028"},"secondaryIdInfos":[{"id":"R37AA014028","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R37AA014028"},{"id":"MERIT"}],"organization":{"fullName":"The Scripps Research Institute","class":"OTHER"},"briefTitle":"Duloxetine Versus Pregabalin for Alcohol Dependence","officialTitle":"Duloxetine Versus Pregabalin for Alcohol Dependence"},"statusModule":{"statusVerifiedDate":"2017-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-07"},"primaryCompletionDateStruct":{"date":"2014-10","type":"ACTUAL"},"completionDateStruct":{"date":"2014-10","type":"ACTUAL"},"studyFirstSubmitDate":"2009-06-26","studyFirstSubmitQcDate":"2009-06-26","studyFirstPostDateStruct":{"date":"2009-06-29","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-02-08","resultsFirstSubmitQcDate":"2017-02-08","resultsFirstPostDateStruct":{"date":"2017-03-28","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-03-30","lastUpdatePostDateStruct":{"date":"2017-05-04","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Barbara J. Mason","investigatorTitle":"PI","investigatorAffiliation":"The Scripps Research Institute"},"leadSponsor":{"name":"The Scripps Research Institute","class":"OTHER"},"collaborators":[{"name":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"A 12-week, double-blind, placebo-controlled parallel group study will be conducted with 150 outpatients with alcohol dependence, with random assignment to pregabalin 300 mg/d, duloxetine 40 mg/d, or placebo in conjunction with manual-guided behavioral counseling and follow-up visits 1 week and 3 months post-treatment."},"conditionsModule":{"conditions":["Alcohol Dependence"],"keywords":["Alcohol","Alcohol treatment","Alcoholism","Alcohol Abuse","Alcohol Dependence"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":150,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Duloxetine","type":"EXPERIMENTAL","interventionNames":["Drug: Duloxetine","Behavioral: Standardized behavioral therapy"]},{"label":"Pregabalin","type":"EXPERIMENTAL","interventionNames":["Drug: Pregabalin","Behavioral: Standardized behavioral therapy"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo","Behavioral: Standardized behavioral therapy"]}],"interventions":[{"type":"DRUG","name":"Pregabalin","description":"Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.","armGroupLabels":["Pregabalin"],"otherNames":["Lyrica"]},{"type":"DRUG","name":"Duloxetine","description":"40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.","armGroupLabels":["Duloxetine"],"otherNames":["Cymbalta"]},{"type":"BEHAVIORAL","name":"Standardized behavioral therapy","description":"Standardized behavioral therapy 1 time per week for 12 week duration.","armGroupLabels":["Duloxetine"],"otherNames":["Manually-guided therapy"]},{"type":"BEHAVIORAL","name":"Standardized behavioral therapy","description":"Standardized behavioral therapy 1 time per week for 12 week duration.","armGroupLabels":["Pregabalin"],"otherNames":["Manually-guided therapy"]},{"type":"DRUG","name":"Placebo","description":"Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.","armGroupLabels":["Placebo"]},{"type":"BEHAVIORAL","name":"Standardized behavioral therapy","description":"Standardized behavioral therapy 1 time per week for 12 week duration.","armGroupLabels":["Placebo"],"otherNames":["Manually-guided therapy"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12","description":"Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.","timeFrame":"Baseline and Week 12"},{"measure":"Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12","description":"Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.","timeFrame":"Baseline and Week 12"},{"measure":"Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12","description":"Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.","timeFrame":"Baseline and Week 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Males or females 18 years of age\n* Meets DSM-IV criteria for current alcohol dependence and drinking an average of ≥21 drinks weekly for males, ≥14 females,\n* Seeking research-based outpatient treatment for alcohol problems\n* Willing to attend 12 weekly study visits and 2 follow-up visits\n* Have normal bilirubin, and ALT, AST, and GGT values no more than 3x the ULN, and no evidence of hepatic insufficiency\n\nExclusion Criteria:\n\n* Active suicidal ideation\n* Medical disorders that will increase potential risk or interfere with study participation\n* Sexually active female subjects with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control\n* Males who refuse to use a reliable method of birth control\n* Meets DSM-IV criteria for any other current major AXIS I disorder other than alcohol or nicotine dependence.\n* Inability to understand and/or comply with the provisions of the protocol and consent form\n* Treatment with an antidepressant medication during the two weeks, or fluoxetine during the month, prior to randomization\n* Ongoing treatment with disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral) or other medications that may affect study outcomes, e.g., anticonvulsants or other drugs that act on serotonin in the brain\n* Ongoing treatment with drugs that may increase potential risk (Actos),","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Barbara J Mason, Ph.D.","affiliation":"The Scripps Research Institute","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research","city":"La Jolla","state":"California","zip":"92037","country":"United States","geoPoint":{"lat":32.84727,"lon":-117.2742}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Study Information","url":"http://alcoholismmarijuanatreatment.com/"}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Duloxetine","description":"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."},{"id":"FG001","title":"Pregabalin","description":"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."},{"id":"FG002","title":"Placebo","description":"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"50"},{"groupId":"FG002","numSubjects":"50"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"37"},{"groupId":"FG002","numSubjects":"29"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"21"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Duloxetine","description":"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."},{"id":"BG001","title":"Pregabalin","description":"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."},{"id":"BG002","title":"Placebo","description":"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"50"},{"groupId":"BG003","value":"150"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.86","spread":"10.53"},{"groupId":"BG001","value":"44.56","spread":"11.55"},{"groupId":"BG002","value":"43.54","spread":"10.52"},{"groupId":"BG003","value":"44.32","spread":"10.82"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"23"},{"groupId":"BG003","value":"55"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"37"},{"groupId":"BG002","value":"27"},{"groupId":"BG003","value":"95"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12","description":"Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"drinks/week","timeFrame":"Baseline and Week 12","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."},{"id":"OG001","title":"Pregabalin","description":"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."},{"id":"OG002","title":"Placebo","description":"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"29"}]}],"classes":[{"title":"Drinks/week Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"42.07","spread":"17.94"},{"groupId":"OG001","value":"56.67","spread":"50.93"},{"groupId":"OG002","value":"41.20","spread":"27.39"}]}]},{"title":"Drinks/week Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"9.16","spread":"11.90"},{"groupId":"OG001","value":"7.59","spread":"15.73"},{"groupId":"OG002","value":"8.06","spread":"11.22"}]}]},{"title":"Drinks/week Change","categories":[{"measurements":[{"groupId":"OG000","value":"-32.91","spread":"20.38"},{"groupId":"OG001","value":"-49.08","spread":"44.91"},{"groupId":"OG002","value":"-33.15","spread":"23.32"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12","description":"Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"drinking days/week","timeFrame":"Baseline and Week 12","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."},{"id":"OG001","title":"Pregabalin","description":"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."},{"id":"OG002","title":"Placebo","description":"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"29"}]}],"classes":[{"title":"Drinking Days/Week Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"5.11","spread":"1.29"},{"groupId":"OG001","value":"4.54","spread":"1.64"},{"groupId":"OG002","value":"4.87","spread":"1.60"}]}]},{"title":"Drinking Days/Week Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"2.17","spread":"2.59"},{"groupId":"OG001","value":"1.14","spread":"1.90"},{"groupId":"OG002","value":"1.85","spread":"2.20"}]}]},{"title":"Drinking Days/Week Change","categories":[{"measurements":[{"groupId":"OG000","value":"-2.94","spread":"2.68"},{"groupId":"OG001","value":"-3.40","spread":"2.03"},{"groupId":"OG002","value":"-3.01","spread":"2.20"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12","description":"Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"drinks/drinking day","timeFrame":"Baseline and Week 12","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."},{"id":"OG001","title":"Pregabalin","description":"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."},{"id":"OG002","title":"Placebo","description":"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"29"}]}],"classes":[{"title":"Drinks/Drinking Day Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"8.16","spread":"2.69"},{"groupId":"OG001","value":"12.98","spread":"11.14"},{"groupId":"OG002","value":"8.91","spread":"5.41"}]}]},{"title":"Drinks/Drinking Day Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"2.21","spread":"2.65"},{"groupId":"OG001","value":"2.31","spread":"3.81"},{"groupId":"OG002","value":"2.90","spread":"3.62"}]}]},{"title":"Drinks/Drinking Day Change","categories":[{"measurements":[{"groupId":"OG000","value":"-5.94","spread":"3.54"},{"groupId":"OG001","value":"-10.67","spread":"11.34"},{"groupId":"OG002","value":"-6.01","spread":"4.84"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24.","description":"Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.","eventGroups":[{"id":"EG000","title":"Duloxetine","description":"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.","seriousNumAffected":2,"seriousNumAtRisk":50,"otherNumAffected":43,"otherNumAtRisk":50},{"id":"EG001","title":"Pregabalin","description":"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.","seriousNumAffected":0,"seriousNumAtRisk":50,"otherNumAffected":35,"otherNumAtRisk":50},{"id":"EG002","title":"Placebo","description":"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.\n\nStandardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.","seriousNumAffected":4,"seriousNumAtRisk":50,"otherNumAffected":33,"otherNumAtRisk":50}],"seriousEvents":[{"term":"Cardiac failure congestive","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":50},{"groupId":"EG001","numAffected":0,"numAtRisk":50},{"groupId":"EG002","numAffected":1,"numAtRisk":50}]},{"term":"Chest 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complications","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50},{"groupId":"EG001","numAffected":0,"numAtRisk":50},{"groupId":"EG002","numAffected":0,"numAtRisk":50}]},{"term":"Suicidal ideation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":50},{"groupId":"EG001","numAffected":0,"numAtRisk":50},{"groupId":"EG002","numAffected":1,"numAtRisk":50}]},{"term":"Asthma","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50},{"groupId":"EG001","numAffected":0,"numAtRisk":50},{"groupId":"EG002","numAffected":0,"numAtRisk":50}]},{"term":"Dyspnoea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 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19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":50},{"groupId":"EG001","numAffected":0,"numAtRisk":50},{"groupId":"EG002","numAffected":1,"numAtRisk":50}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":50},{"groupId":"EG001","numAffected":9,"numAtRisk":50},{"groupId":"EG002","numAffected":3,"numAtRisk":50}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":50},{"groupId":"EG001","numAffected":1,"numAtRisk":50},{"groupId":"EG002","numAffected":1,"numAtRisk":50}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":50},{"groupId":"EG001","numAffected":6,"numAtRisk":50},{"groupId":"EG002","numAffected":2,"numAtRisk":50}]},{"term":"Toothache","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50},{"groupId":"EG001","numAffected":3,"numAtRisk":50},{"groupId":"EG002","numAffected":3,"numAtRisk":50}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":50},{"groupId":"EG001","numAffected":3,"numAtRisk":50},{"groupId":"EG002","numAffected":4,"numAtRisk":50}]},{"term":"Bronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50},{"groupId":"EG001","numAffected":4,"numAtRisk":50},{"groupId":"EG002","numAffected":2,"numAtRisk":50}]},{"term":"Influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":50},{"groupId":"EG001","numAffected":2,"numAtRisk":50},{"groupId":"EG002","numAffected":2,"numAtRisk":50}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":50},{"groupId":"EG001","numAffected":9,"numAtRisk":50},{"groupId":"EG002","numAffected":16,"numAtRisk":50}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":50},{"groupId":"EG001","numAffected":4,"numAtRisk":50},{"groupId":"EG002","numAffected":2,"numAtRisk":50}]},{"term":"Hepatic enzyme increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":50},{"groupId":"EG001","numAffected":0,"numAtRisk":50},{"groupId":"EG002","numAffected":0,"numAtRisk":50}]},{"term":"Abnormal weight gain","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":50},{"groupId":"EG001","numAffected":3,"numAtRisk":50},{"groupId":"EG002","numAffected":0,"numAtRisk":50}]},{"term":"Increased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 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