{"protocolSection":{"identificationModule":{"nctId":"NCT01034462","orgStudyIdInfo":{"id":"LVM-MD-03"},"organization":{"fullName":"Forest Laboratories","class":"INDUSTRY"},"briefTitle":"Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder","officialTitle":"A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2013-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-12"},"primaryCompletionDateStruct":{"date":"2011-12","type":"ACTUAL"},"completionDateStruct":{"date":"2011-12","type":"ACTUAL"},"studyFirstSubmitDate":"2009-12-16","studyFirstSubmitQcDate":"2009-12-16","studyFirstPostDateStruct":{"date":"2009-12-17","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-08-22","resultsFirstSubmitQcDate":"2013-08-22","resultsFirstPostDateStruct":{"date":"2013-10-25","type":"ESTIMATED"},"dispFirstSubmitDate":"2011-12-30","dispFirstSubmitQcDate":"2011-12-30","dispFirstPostDateStruct":{"date":"2012-01-04","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-08-22","lastUpdatePostDateStruct":{"date":"2013-10-25","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Forest Laboratories","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder"},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Depression","Major Depressive Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":442,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1","type":"EXPERIMENTAL","description":"Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.","interventionNames":["Drug: Levomilnacipran ER"]},{"label":"2","type":"PLACEBO_COMPARATOR","description":"Matching placebo capsules, oral administration, once daily dosing.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Levomilnacipran ER","description":"Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. Study drug is to be given orally, in capsule form, once daily, for 8 weeks","armGroupLabels":["1"]},{"type":"DRUG","name":"Placebo","description":"Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.","armGroupLabels":["2"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score","description":"MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.\n\nEach item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity).","timeFrame":"From Baseline to Week 8"}],"secondaryOutcomes":[{"measure":"Change in Sheehan Disability Scale (SDS) Total Score","description":"The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)","timeFrame":"From Baseline to Week 8"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Men and women, 18-80 years old\n* Currently meet the DSM-IV-TR criteria for Major Depressive Disorder\n* The patient's current depressive episode must be at least 4 weeks in duration\n\nExclusion Criteria:\n\n* Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.\n* Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.\n* Patients who are considered a suicide risk","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"80 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Carl Gommoll, MS","affiliation":"Forest Research Institute, a subsidiary of Forest Laboratories Inc.","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Forest Investigative Site 055","city":"Dothan","state":"Alabama","zip":"36305","country":"United States","geoPoint":{"lat":31.22323,"lon":-85.39049}},{"facility":"Forest Investigative Site 065","city":"Highlands Ranch","state":"Colorado","zip":"80130","country":"United States","geoPoint":{"lat":39.55388,"lon":-104.96943}},{"facility":"Forest Investigative Site 057","city":"Boca Raton","state":"Florida","zip":"33431","country":"United States","geoPoint":{"lat":26.35869,"lon":-80.0831}},{"facility":"Forest Investigative Site 060","city":"Boca Raton","state":"Florida","zip":"33432","country":"United States","geoPoint":{"lat":26.35869,"lon":-80.0831}},{"facility":"Forest Investigative Site 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072","city":"Chicago","state":"Illinois","zip":"60634","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"Forest Investigative Site 050","city":"Oak Brook","state":"Illinois","zip":"60523","country":"United States","geoPoint":{"lat":41.83281,"lon":-87.92895}},{"facility":"Forest Investigative Site 063","city":"Indianapolis","state":"Indiana","zip":"46260","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Forest Investigative Site 071","city":"Prairie Village","state":"Kansas","zip":"66206","country":"United States","geoPoint":{"lat":38.99167,"lon":-94.63357}},{"facility":"Forest Investigative Site 052","city":"Shreveport","state":"Louisiana","zip":"71104","country":"United States","geoPoint":{"lat":32.52515,"lon":-93.75018}},{"facility":"Forest Investigative Site 051","city":"Brooklyn","state":"New York","zip":"11214","country":"United States","geoPoint":{"lat":40.6501,"lon":-73.94958}},{"facility":"Forest Investigative Site 056","city":"Oklahoma City","state":"Oklahoma","zip":"73112","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"Forest Investigative Site 067","city":"Oklahoma City","state":"Oklahoma","zip":"73112","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"Forest Investigative Site 058","city":"Salem","state":"Oregon","zip":"97301","country":"United States","geoPoint":{"lat":44.9429,"lon":-123.0351}},{"facility":"Forest Investigative Site 054","city":"Allentown","state":"Pennsylvania","zip":"18104","country":"United States","geoPoint":{"lat":40.60843,"lon":-75.49018}},{"facility":"Forest Investigative Site 062","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Forest Investigative Site 068","city":"Virginia Beach","state":"Virginia","zip":"23452","country":"United States","geoPoint":{"lat":36.85293,"lon":-75.97799}},{"facility":"Forest Investigative Site 069","city":"Spokane","state":"Washington","zip":"99204","country":"United States","geoPoint":{"lat":47.65966,"lon":-117.42908}}]},"referencesModule":{"references":[{"pmid":"27861191","type":"DERIVED","citation":"Wesnes KA, Gommoll C, Chen C, Sambunaris A, McIntyre RS, Harvey PD. Effects of levomilnacipran extended-release on major depressive disorder patients with cognitive impairments: post-hoc analysis of a phase III study. Int Clin Psychopharmacol. 2017 Mar;32(2):72-79. doi: 10.1097/YIC.0000000000000157."},{"pmid":"26644957","type":"DERIVED","citation":"Cutler AJ, Gommoll CP, Chen C, Greenberg WM, Ruth A. Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories. Prim Care Companion CNS Disord. 2015 Jun 11;17(3):10.4088/PCC.14m01753. doi: 10.4088/PCC.14m01753. eCollection 2015."},{"pmid":"24172209","type":"DERIVED","citation":"Sambunaris A, Bose A, Gommoll CP, Chen C, Greenberg WM, Sheehan DV. A phase III, double-blind, placebo-controlled, flexible-dose study of levomilnacipran extended-release in patients with major depressive disorder. J Clin Psychopharmacol. 2014 Feb;34(1):47-56. doi: 10.1097/JCP.0000000000000060."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Patients went through a 1-week single-blind placebo run-in period immediately preceding an 8-week double-blind treatment period.","recruitmentDetails":"Patient were recruited over a 21-month period from December of 2009 to September of 2011 at 23 studies sites in the United States.","groups":[{"id":"FG000","title":"Placebo","description":"Matching placebo capsules, oral administration, once daily dosing for 8 weeks."},{"id":"FG001","title":"Levomilnacipran ER","description":"Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"217"},{"groupId":"FG001","numSubjects":"217"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"172"},{"groupId":"FG001","numSubjects":"163"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"45"},{"groupId":"FG001","numSubjects":"54"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"17"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"8"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"16"}]},{"type":"Other reasons","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"While 442 patients were randomized to receive double-blind treatment, 8 of these patients discontined before receiving double-blind treatment. The Baseline Participant population is based on the 434 randomized patients who went on to receive double-blind treatment (Safety Population).","groups":[{"id":"BG000","title":"Placebo","description":"Matching placebo capsules, oral administration, once daily dosing for 8 weeks."},{"id":"BG001","title":"Levomilnacipran ER","description":"Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"217"},{"groupId":"BG001","value":"217"},{"groupId":"BG002","value":"434"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.6","spread":"13.9"},{"groupId":"BG001","value":"45.0","spread":"13.2"},{"groupId":"BG002","value":"44.8","spread":"13.5"}]}]}]},{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"18 years to 19 years","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]}]},{"title":"20 years to 29 years","categories":[{"measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"34"},{"groupId":"BG002","value":"72"}]}]},{"title":"30 years to 39 years","categories":[{"measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"44"},{"groupId":"BG002","value":"81"}]}]},{"title":"40 years to 49 years","categories":[{"measurements":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"91"}]}]},{"title":"50 years to 59 years","categories":[{"measurements":[{"groupId":"BG000","value":"57"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"125"}]}]},{"title":"60 years to 80 years","categories":[{"measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"61"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"143"},{"groupId":"BG001","value":"140"},{"groupId":"BG002","value":"283"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"74"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"151"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"182"},{"groupId":"BG001","value":"177"},{"groupId":"BG002","value":"359"}]}]},{"title":"Black or African American","categories":[{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"61"}]}]},{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]}]},{"title":"American Indian or Alaska native","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}]},{"title":"Other","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]}]},{"title":"Hispanic or Latino","categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"38"}]}]},{"title":"Not Hispanic or Latino","categories":[{"measurements":[{"groupId":"BG000","value":"200"},{"groupId":"BG001","value":"196"},{"groupId":"BG002","value":"396"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"217"},{"groupId":"BG001","value":"217"},{"groupId":"BG002","value":"434"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"84.58","spread":"18.15"},{"groupId":"BG001","value":"84.47","spread":"18.98"},{"groupId":"BG002","value":"84.52","spread":"18.55"}]}]}]},{"title":"Body Mass Index (BMI)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Kilograms Per Meter Squared","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"29.60","spread":"5.30"},{"groupId":"BG001","value":"29.20","spread":"5.45"},{"groupId":"BG002","value":"29.40","spread":"5.37"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score","description":"MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.\n\nEach item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity).","populationDescription":"The Safety Population consisted of 434 randomized patients who took at least 1 dose of double-blind investigational product. The Intent-to-Treat (ITT) Population consisted 429 patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"From Baseline to Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo capsules, oral administration, once daily dosing.\n\nPlacebo : Matching placebo to be given orally, in capsule form, once daily, for 8 weeks."},{"id":"OG001","title":"Levomilnacipran ER","description":"Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"214"},{"groupId":"OG001","value":"215"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-12.2","spread":"0.78"},{"groupId":"OG001","value":"-15.3","spread":"0.79"}]}]}],"analyses":[{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0051","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures.","paramType":"Least squares mean difference","paramValue":"-3.095","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.256","ciUpperLimit":"-0.935"}]},{"type":"SECONDARY","title":"Change in Sheehan Disability Scale (SDS) Total Score","description":"The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)","populationDescription":"The Safety Population consisted of 434 randomized patients who took at least 1 dose of double-blind investigational product.\n\nThe Intent-to-Treat (ITT) Population consisted 429 patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"From Baseline to Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo capsules, oral administration, once daily dosing for 8 weeks."},{"id":"OG001","title":"Levomilnacipran ER","description":"Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"214"},{"groupId":"OG001","value":"215"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.4","spread":"0.57"},{"groupId":"OG001","value":"-8.0","spread":"0.58"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0010","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures.","paramType":"Least squares mean difference","paramValue":"-2.632","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.193","ciUpperLimit":"-1.070"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Adverse event data was collection over a 25-month period from December 2009 to January 2012 at 23 study sites in the U.S.","description":"The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Matching placebo capsules, oral administration, once daily dosing for 8 weeks.","seriousNumAffected":3,"seriousNumAtRisk":217,"otherNumAffected":79,"otherNumAtRisk":217},{"id":"EG001","title":"Levomilnacipran ER","description":"Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.","seriousNumAffected":4,"seriousNumAtRisk":217,"otherNumAffected":151,"otherNumAtRisk":217}],"seriousEvents":[{"term":"Non-cardiac chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":217},{"groupId":"EG001","numAffected":1,"numAtRisk":217}]},{"term":"Head injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":217},{"groupId":"EG001","numAffected":0,"numAtRisk":217}]},{"term":"Road traffic accident","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":217},{"groupId":"EG001","numAffected":1,"numAtRisk":217}]},{"term":"Traumatic liver injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":217},{"groupId":"EG001","numAffected":0,"numAtRisk":217}]},{"term":"Asthma","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":217},{"groupId":"EG001","numAffected":0,"numAtRisk":217}]},{"term":"Chronic obstructive pulmonary disease","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":217},{"groupId":"EG001","numAffected":0,"numAtRisk":217}]},{"term":"Intentional overdose","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":217},{"groupId":"EG001","numAffected":1,"numAtRisk":217}]},{"term":"Suicide attempt","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":217},{"groupId":"EG001","numAffected":1,"numAtRisk":217}]},{"term":"Back Pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":217},{"groupId":"EG001","numAffected":1,"numAtRisk":217}]},{"term":"Road traffic accident","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":217},{"groupId":"EG001","numAffected":1,"numAtRisk":217}]},{"term":"Scratch","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":217},{"groupId":"EG001","numAffected":1,"numAtRisk":217}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":217},{"groupId":"EG001","numAffected":2,"numAtRisk":217}]},{"term":"Suicidal ideation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":217},{"groupId":"EG001","numAffected":2,"numAtRisk":217}]}],"otherEvents":[{"term":"Nausea","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":217},{"groupId":"EG001","numAffected":47,"numAtRisk":217}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":217},{"groupId":"EG001","numAffected":38,"numAtRisk":217}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":217},{"groupId":"EG001","numAffected":28,"numAtRisk":217}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":217},{"groupId":"EG001","numAffected":27,"numAtRisk":217}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":217},{"groupId":"EG001","numAffected":22,"numAtRisk":217}]},{"term":"Tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":217},{"groupId":"EG001","numAffected":18,"numAtRisk":217}]},{"term":"Urinary hesitation","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":217},{"groupId":"EG001","numAffected":17,"numAtRisk":217}]},{"term":"Hyperhidrosis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":217},{"groupId":"EG001","numAffected":15,"numAtRisk":217}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":217},{"groupId":"EG001","numAffected":15,"numAtRisk":217}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":217},{"groupId":"EG001","numAffected":14,"numAtRisk":217}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":217},{"groupId":"EG001","numAffected":14,"numAtRisk":217}]},{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":217},{"groupId":"EG001","numAffected":13,"numAtRisk":217}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":217},{"groupId":"EG001","numAffected":12,"numAtRisk":217}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.\n\nPublication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc."},"pointOfContact":{"title":"Carl Gommoll, MS, Sr. Dir. 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