{"protocolSection":{"identificationModule":{"nctId":"NCT00797797","orgStudyIdInfo":{"id":"MLN-MD-15"},"organization":{"fullName":"Forest Laboratories","class":"INDUSTRY"},"briefTitle":"Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia","officialTitle":"A Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran When Added to Pregabalin in the Treatment of Fibromyalgia"},"statusModule":{"statusVerifiedDate":"2011-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-11"},"primaryCompletionDateStruct":{"date":"2009-11","type":"ACTUAL"},"completionDateStruct":{"date":"2010-01","type":"ACTUAL"},"studyFirstSubmitDate":"2008-11-24","studyFirstSubmitQcDate":"2008-11-24","studyFirstPostDateStruct":{"date":"2008-11-25","type":"ESTIMATED"},"resultsFirstSubmitDate":"2010-11-18","resultsFirstSubmitQcDate":"2011-01-20","resultsFirstPostDateStruct":{"date":"2011-02-16","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-01-20","lastUpdatePostDateStruct":{"date":"2011-02-16","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"James Perhach, Executive Director, Clinical Development","oldOrganization":"Forest Research Institute Inc (A Subsidiary of Forest Laboratories Inc)"},"leadSponsor":{"name":"Forest Laboratories","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia."},"conditionsModule":{"conditions":["Fibromyalgia"],"keywords":["fibromyalgia","milnacipran","pregabalin","treatment","Forest Research Institute"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":364,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Milnacipran Added","type":"EXPERIMENTAL","interventionNames":["Drug: Milnacipran Added"]},{"label":"No Treatment Added","type":"EXPERIMENTAL","interventionNames":["Drug: No Treatment Added"]}],"interventions":[{"type":"DRUG","name":"No Treatment Added","description":"No added treatment","armGroupLabels":["No Treatment Added"],"otherNames":["Lyrica (r)"]},{"type":"DRUG","name":"Milnacipran Added","description":"Milnacipran 100 mg/d added","armGroupLabels":["Milnacipran Added"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Patient Global Impression of Change (PGIC) Responder Rate at End of Study","description":"The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as \"very much improved\" or \"much improved\" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.","timeFrame":"End of Randomized treatment period (11 weeks)"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study","description":"The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain).","timeFrame":"Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria\n* tolerate at least 300 mg/day of pregabalin\n* have an incomplete response to pregabalin treatment\n\nExclusion Criteria:\n\n* suicidal risk\n* substance abuse\n* pulmonary dysfunction\n* renal impairment\n* active cardiac disease\n* liver disease\n* narrow angle glaucoma\n* autoimmune disease\n* cancer\n* inflammatory bowel disease\n* unstable endocrine disease\n* prostatic enlargement","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Patricia D'Astoli","affiliation":"Forest Research Institute, a subsidiary of Forest Laboratories, Inc.","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Forest Investigative Site","city":"Birmingham","state":"Alabama","zip":"35205","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Forest Investigative Site","city":"Mesa","state":"Arizona","zip":"85210","country":"United States","geoPoint":{"lat":33.42227,"lon":-111.82264}},{"facility":"Forest Investigative Site","city":"Peoria","state":"Arizona","zip":"85381","country":"United States","geoPoint":{"lat":33.5806,"lon":-112.23738}},{"facility":"Forest Investigative Site","city":"Hot Springs","state":"Arkansas","zip":"71913","country":"United States","geoPoint":{"lat":34.5037,"lon":-93.05518}},{"facility":"Forest Investigative Site","city":"Anaheim","state":"California","zip":"92801","country":"United States","geoPoint":{"lat":33.83529,"lon":-117.9145}},{"facility":"Forest Investigative Site","city":"Sacramento","state":"California","zip":"95821","country":"United States","geoPoint":{"lat":38.58157,"lon":-121.4944}},{"facility":"Forest Investigative Site","city":"Sacramento","state":"California","zip":"95825","country":"United States","geoPoint":{"lat":38.58157,"lon":-121.4944}},{"facility":"Forest Investigative Site","city":"Torrance","state":"California","zip":"90505","country":"United States","geoPoint":{"lat":33.83585,"lon":-118.34063}},{"facility":"Forest Investigative Site","city":"Walnut Creek","state":"California","zip":"94598","country":"United States","geoPoint":{"lat":37.90631,"lon":-122.06496}},{"facility":"Forest Investigative Site","city":"Denver","state":"Colorado","zip":"80239","country":"United States","geoPoint":{"lat":39.73915,"lon":-104.9847}},{"facility":"Forest Investigative Site","city":"Cromwell","state":"Connecticut","zip":"06416","country":"United States","geoPoint":{"lat":41.5951,"lon":-72.64537}},{"facility":"Forest Investigative Site","city":"Danbury","state":"Connecticut","zip":"06810","country":"United States","geoPoint":{"lat":41.39482,"lon":-73.45401}},{"facility":"Forest Investigative Site","city":"Clearwater","state":"Florida","zip":"33765","country":"United States","geoPoint":{"lat":27.96585,"lon":-82.8001}},{"facility":"Forest Investigative Site","city":"Daytona Beach","state":"Florida","zip":"32117","country":"United States","geoPoint":{"lat":29.21081,"lon":-81.02283}},{"facility":"Forest Investigative Site","city":"Delray Beach","state":"Florida","zip":"33484","country":"United States","geoPoint":{"lat":26.46146,"lon":-80.07282}},{"facility":"Forest Investigative Site","city":"Fort Myers","state":"Florida","zip":"33912","country":"United States","geoPoint":{"lat":26.62168,"lon":-81.84059}},{"facility":"Forest Investigative Site","city":"Jacksonville","state":"Florida","zip":"32216","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Forest Investigative Site","city":"Miami","state":"Florida","zip":"33169","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Forest Investigative Site","city":"Ocala","state":"Florida","zip":"34471","country":"United States","geoPoint":{"lat":29.1872,"lon":-82.14009}},{"facility":"Forest Investigative Site Orl2","city":"Orlando","state":"Florida","zip":"32806","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Forest Investigative Site","city":"Orlando","state":"Florida","zip":"32806","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Forest Investigative Site","city":"Ormond Beach","state":"Florida","zip":"32174","country":"United States","geoPoint":{"lat":29.28581,"lon":-81.05589}},{"facility":"Forest Investigative Site PP1","city":"Pembroke Pines","state":"Florida","zip":"33024","country":"United States","geoPoint":{"lat":26.00315,"lon":-80.22394}},{"facility":"Forest Investigative Site PP2","city":"Pembroke Pines","state":"Florida","zip":"33029","country":"United States","geoPoint":{"lat":26.00315,"lon":-80.22394}},{"facility":"Forest Investigative Site","city":"Pismo Beach","state":"Florida","zip":"93449","country":"United States"},{"facility":"Forest Investigative Site","city":"St. Petersburg","state":"Florida","zip":"33709","country":"United States","geoPoint":{"lat":27.77086,"lon":-82.67927}},{"facility":"Forest Investigative Site","city":"Tampa","state":"Florida","zip":"33614","country":"United States","geoPoint":{"lat":27.94752,"lon":-82.45843}},{"facility":"Forest Investigative Site","city":"Atlanta","state":"Georgia","zip":"30328","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"Forest Investigative Site","city":"Honolulu","state":"Hawaii","zip":"96814","country":"United States","geoPoint":{"lat":21.30694,"lon":-157.85833}},{"facility":"Forest Investigative Site","city":"Couer D'Alene","state":"Idaho","zip":"83814","country":"United States"},{"facility":"Forest Investigative Site","city":"Evansville","state":"Indiana","zip":"47713","country":"United States","geoPoint":{"lat":37.97476,"lon":-87.55585}},{"facility":"Forest Investigative Site","city":"Indianapolis","state":"Indiana","zip":"46254","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Forest Investigative Site","city":"Indianapolis","state":"Indiana","zip":"46260","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Forest Investigative Site","city":"Baltimore","state":"Maryland","zip":"21208","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}},{"facility":"Forest Investigative Site","city":"No. Dartmouth","state":"Massachusetts","zip":"02747","country":"United States"},{"facility":"Forest Investigative Site","city":"Worcester","state":"Massachusetts","zip":"01610","country":"United States","geoPoint":{"lat":42.26259,"lon":-71.80229}},{"facility":"Forest Investigative Site","city":"Jackson","state":"Mississippi","zip":"39202","country":"United States","geoPoint":{"lat":32.29876,"lon":-90.18481}},{"facility":"Forest Investigative Site","city":"St Louis","state":"Missouri","zip":"63141","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"Forest Investigative Site","city":"Omaha","state":"Nebraska","zip":"68134","country":"United States","geoPoint":{"lat":41.25626,"lon":-95.94043}},{"facility":"Forest Investigative Site","city":"Albuquerque","state":"New Mexico","zip":"87108","country":"United States","geoPoint":{"lat":35.08449,"lon":-106.65114}},{"facility":"Forest Investigative Site","city":"Syracuse","state":"New York","zip":"13210","country":"United States","geoPoint":{"lat":43.04812,"lon":-76.14742}},{"facility":"Forest Investigative Site","city":"Cincinnati","state":"Ohio","zip":"45219","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"Forest Investigative Site","city":"Cleveland","state":"Ohio","zip":"44122","country":"United States","geoPoint":{"lat":41.4995,"lon":-81.69541}},{"facility":"Forest Investigative Site","city":"Eugene","state":"Oregon","zip":"97404","country":"United States","geoPoint":{"lat":44.05207,"lon":-123.08675}},{"facility":"Forest Investigative Site","city":"Medford","state":"Oregon","zip":"97504","country":"United States","geoPoint":{"lat":42.32652,"lon":-122.87559}},{"facility":"Forest Investigative Site","city":"Portland","state":"Oregon","zip":"97210","country":"United States","geoPoint":{"lat":45.52345,"lon":-122.67621}},{"facility":"Forest Investigative Site","city":"Greer","state":"South Carolina","zip":"29651","country":"United States","geoPoint":{"lat":34.93873,"lon":-82.22706}},{"facility":"Forest Investigative Site","city":"Memphis","state":"Tennessee","zip":"38119","country":"United States","geoPoint":{"lat":35.14953,"lon":-90.04898}},{"facility":"Forest Investigative Site","city":"Houston","state":"Texas","zip":"77074","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Forest Investigative Site","city":"Houston","state":"Texas","zip":"77104","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Forest Investigative Site","city":"Lake Jackson","state":"Texas","zip":"77566","country":"United States","geoPoint":{"lat":29.03386,"lon":-95.43439}},{"facility":"Forest Investigative Site","city":"Salt Lake City","state":"Utah","zip":"84102","country":"United States","geoPoint":{"lat":40.76078,"lon":-111.89105}},{"facility":"Forest Investigative Site","city":"Salt Lake City","state":"Utah","zip":"84106","country":"United States","geoPoint":{"lat":40.76078,"lon":-111.89105}},{"facility":"Forest Investigative Site","city":"Woodstock","state":"Vermont","zip":"05091","country":"United States","geoPoint":{"lat":43.62424,"lon":-72.51843}},{"facility":"Forest Investigative Site","city":"Bellevue","state":"Washington","zip":"98004","country":"United States","geoPoint":{"lat":47.61038,"lon":-122.20068}},{"facility":"Forest Investigative Site","city":"Bellingham","state":"Washington","zip":"98226","country":"United States","geoPoint":{"lat":48.75955,"lon":-122.48822}},{"facility":"Forest Investigative Site SEA1","city":"Seattle","state":"Washington","zip":"98104","country":"United States","geoPoint":{"lat":47.60621,"lon":-122.33207}},{"facility":"Forest Investigative Site SEA2","city":"Seattle","state":"Washington","zip":"98104","country":"United States","geoPoint":{"lat":47.60621,"lon":-122.33207}},{"facility":"Forest Investigative Site","city":"Spokane","state":"Washington","zip":"99204","country":"United States","geoPoint":{"lat":47.65966,"lon":-117.42908}},{"facility":"Forest Investigative Site","city":"Racine","state":"Wisconsin","zip":"53406","country":"United States","geoPoint":{"lat":42.72613,"lon":-87.78285}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants entered an open label pregabalin period concurrent with prohibited medication washout. Incomplete responders to pregabalin were randomized to receive either milnacipran (100 mg/d) or no added treatment for 11 weeks. All participant continued background stable dose pregabalin (300 or 450 mg/d) throughout the randomized treatment period.","recruitmentDetails":"Participants were recruited and enrolled in this study within the US from December 2008 to June 2009.","groups":[{"id":"FG000","title":"No Treatment Added","description":"No treatment added for 11 weeks of randomized treatment period"},{"id":"FG001","title":"Milnacipran Added","description":"Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"Two patients took no background stable dose of pregabalin after randomization and are not included.","numSubjects":"178"},{"groupId":"FG001","numSubjects":"184"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"123"},{"groupId":"FG001","numSubjects":"141"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"55"},{"groupId":"FG001","numSubjects":"43"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"No Treatment Added","description":"No treatment added for 11 weeks of randomized treatment period"},{"id":"BG001","title":"Milnacipran Added","description":"Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"178"},{"groupId":"BG001","value":"184"},{"groupId":"BG002","value":"362"}]}],"measures":[{"title":"Age Categorical","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Between 18 and 60 years","categories":[{"measurements":[{"groupId":"BG000","value":"151"},{"groupId":"BG001","value":"146"},{"groupId":"BG002","value":"297"}]}]},{"title":">=60 years","categories":[{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"65"}]}]}]},{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"48.8","spread":"10.4"},{"groupId":"BG001","value":"49.8","spread":"10.3"},{"groupId":"BG002","value":"49.3","spread":"10.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"159"},{"groupId":"BG001","value":"170"},{"groupId":"BG002","value":"329"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"33"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"178"},{"groupId":"BG001","value":"184"},{"groupId":"BG002","value":"362"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Patient Global Impression of Change (PGIC) Responder Rate at End of Study","description":"The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as \"very much improved\" or \"much improved\" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.","populationDescription":"All efficacy analyses are based on the Intent-to-Treat population, defined as all randomized patients who received at least one dose of randomized study drug and had at least one post-baseline PGIC assessment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"End of Randomized treatment period (11 weeks)","groups":[{"id":"OG000","title":"No Treatment Added","description":"No treatment added for 11 weeks of randomized treatment period"},{"id":"OG001","title":"Milnacipran Added","description":"Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"173"},{"groupId":"OG001","value":"179"}]}],"classes":[{"title":"Responder","categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"83"}]}]},{"title":"Non-Responder","categories":[{"measurements":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"96"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The responder rates between 'No Treatment Added' and 'Milnacipran Added' groups were compared using a logistic regression model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Regression, Logistic"}]},{"type":"SECONDARY","title":"Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study","description":"The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm","timeFrame":"Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)","groups":[{"id":"OG000","title":"No Treatment Added","description":"No treatment added for 11 weeks of randomized treatment period"},{"id":"OG001","title":"Milnacipran Added","description":"Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"173"},{"groupId":"OG001","value":"179"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.43","spread":"1.93"},{"groupId":"OG001","value":"-20.77","spread":"1.92"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"ANCOVA","paramType":"Least Square Mean Difference","paramValue":"-14.35","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-18.99","ciUpperLimit":"-9.71"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Treatment emergent adverse events, defined as adverse events which occurred or worsened after starting randomized study drug, were collected from December 2008 to November 2009.","eventGroups":[{"id":"EG000","title":"No Treatment Added","description":"No treatment added for 11 weeks of randomized treatment period","seriousNumAffected":6,"seriousNumAtRisk":178,"otherNumAffected":38,"otherNumAtRisk":178},{"id":"EG001","title":"Milnacipran Added","description":"Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period","seriousNumAffected":5,"seriousNumAtRisk":184,"otherNumAffected":90,"otherNumAtRisk":184}],"seriousEvents":[{"term":"Suicidal ideation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":178},{"groupId":"EG001","numAffected":2,"numAtRisk":184}]},{"term":"Calculus ureteric","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":178},{"groupId":"EG001","numAffected":0,"numAtRisk":184}]},{"term":"Chest discomfort","organSystem":"General disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":178},{"groupId":"EG001","numAffected":0,"numAtRisk":184}]},{"term":"Chest injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":178},{"groupId":"EG001","numAffected":0,"numAtRisk":184}]},{"term":"Duodenitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":178},{"groupId":"EG001","numAffected":0,"numAtRisk":184}]},{"term":"Gastric ulcer","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":178},{"groupId":"EG001","numAffected":0,"numAtRisk":184}]},{"term":"Inverteral disc disorder","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":178},{"groupId":"EG001","numAffected":0,"numAtRisk":184}]},{"term":"Road traffic accident","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":178},{"groupId":"EG001","numAffected":0,"numAtRisk":184}]},{"term":"Hypertensive crisis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":178},{"groupId":"EG001","numAffected":1,"numAtRisk":184}]},{"term":"Hysterectomy","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":178},{"groupId":"EG001","numAffected":1,"numAtRisk":184}]},{"term":"Irritable bowel syndrome","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":178},{"groupId":"EG001","numAffected":1,"numAtRisk":184}]}],"otherEvents":[{"term":"Palpitations","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":178},{"groupId":"EG001","numAffected":10,"numAtRisk":184}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":178},{"groupId":"EG001","numAffected":23,"numAtRisk":184}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":178},{"groupId":"EG001","numAffected":18,"numAtRisk":184}]},{"term":"Dry Mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":178},{"groupId":"EG001","numAffected":10,"numAtRisk":184}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":178},{"groupId":"EG001","numAffected":19,"numAtRisk":184}]},{"term":"Oedema peripheral","organSystem":"General disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":178},{"groupId":"EG001","numAffected":6,"numAtRisk":184}]},{"term":"Weight Increased","organSystem":"Investigations","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":178},{"groupId":"EG001","numAffected":12,"numAtRisk":184}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":178},{"groupId":"EG001","numAffected":17,"numAtRisk":184}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":178},{"groupId":"EG001","numAffected":14,"numAtRisk":184}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":178},{"groupId":"EG001","numAffected":12,"numAtRisk":184}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":178},{"groupId":"EG001","numAffected":10,"numAtRisk":184}]},{"term":"Hot flush","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (11.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":178},{"groupId":"EG001","numAffected":11,"numAtRisk":184}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true},"pointOfContact":{"title":"Robert Palmer, MD","organization":"Forest Research Institute, a subsidiary of Forest Laboratories, Inc.","email":"robert.palmer@frx.com","phone":"1-201-427-8218"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D005356","term":"Fibromyalgia"}],"ancestors":[{"id":"D009135","term":"Muscular Diseases"},{"id":"D009140","term":"Musculoskeletal Diseases"},{"id":"D012216","term":"Rheumatic Diseases"},{"id":"D009468","term":"Neuromuscular Diseases"},{"id":"D009422","term":"Nervous System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000069583","term":"Pregabalin"}],"ancestors":[{"id":"D005680","term":"gamma-Aminobutyric Acid"},{"id":"D000613","term":"Aminobutyrates"},{"id":"D002087","term":"Butyrates"},{"id":"D000144","term":"Acids, Acyclic"},{"id":"D002264","term":"Carboxylic Acids"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D000596","term":"Amino Acids"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"}]}},"hasResults":true}