{"protocolSection":{"identificationModule":{"nctId":"NCT00863798","orgStudyIdInfo":{"id":"3151A1-3362"},"secondaryIdInfos":[{"id":"B2061005"},{"id":"3151A1-3362-US"}],"organization":{"fullName":"Wyeth is now a wholly owned subsidiary of Pfizer","class":"INDUSTRY"},"briefTitle":"Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder","officialTitle":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy And Safety Of 2 Fixed Doses (10 And 50 mg/Day) Of DVS SR Tablets In Adult Outpatients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2011-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-04"},"primaryCompletionDateStruct":{"date":"2010-03","type":"ACTUAL"},"completionDateStruct":{"date":"2010-03","type":"ACTUAL"},"studyFirstSubmitDate":"2009-03-17","studyFirstSubmitQcDate":"2009-03-17","studyFirstPostDateStruct":{"date":"2009-03-18","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-03-08","resultsFirstSubmitQcDate":"2011-04-07","resultsFirstPostDateStruct":{"date":"2011-05-06","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-04-07","lastUpdatePostDateStruct":{"date":"2011-05-06","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Director, Clinical Trial Disclosure Group","oldOrganization":"Wyeth"},"leadSponsor":{"name":"Wyeth is now a wholly owned subsidiary of Pfizer","class":"INDUSTRY"},"collaborators":[{"name":"Pfizer","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Major Depressive Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":682,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Desvenlafaxine succinate sustained release 10 mg","type":"EXPERIMENTAL","interventionNames":["Drug: Desvenlafaxine Succinate Sustained-Release 10mg"]},{"label":"Desvenlafaxine succinate sustained release 50 mg","type":"EXPERIMENTAL","interventionNames":["Drug: Desvenlafaxine Succinate Sustained-Release 50 mg"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"Desvenlafaxine Succinate Sustained-Release 10mg","description":"10 mg tablet, once daily dosing for 8 weeks","armGroupLabels":["Desvenlafaxine succinate sustained release 10 mg"]},{"type":"DRUG","name":"Desvenlafaxine Succinate Sustained-Release 50 mg","description":"50 mg tablet, once daily dosing for 8 weeks","armGroupLabels":["Desvenlafaxine succinate sustained release 50 mg"]},{"type":"DRUG","name":"placebo","description":"Matching placebo tablets (10 or 50mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET)","description":"HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.","timeFrame":"Baseline and Week 8 (or ET)"}],"secondaryOutcomes":[{"measure":"Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)","description":"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.","timeFrame":"Week 8 (or ET)"},{"measure":"Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)","description":"CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.","timeFrame":"Baseline and Week 8 (or ET )"},{"measure":"Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)","description":"MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).","timeFrame":"Baseline and Week 8 (or ET)"},{"measure":"Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)","description":"HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. 0=none/absent and 22=most severe.The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.","timeFrame":"Baseline and Week 8 (or ET )"},{"measure":"Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)","description":"A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.","timeFrame":"Week 8 (or ET)"},{"measure":"Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)","description":"Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.","timeFrame":"Week 8 (or ET)"},{"measure":"Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)","description":"A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).","timeFrame":"Week 8 (or ET)"},{"measure":"Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)","description":"CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.","timeFrame":"Week 8 (or ET)"}],"otherOutcomes":[{"measure":"Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations","description":"Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.","timeFrame":"Week 2, 4 and 8 (or ET)"},{"measure":"Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)","description":"SDS: a self-administered tools that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.","timeFrame":"Baseline and Week 8 (or ET)"},{"measure":"Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)","description":"WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).","timeFrame":"Baseline and Week 8 (or ET)"},{"measure":"Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)","description":"ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week were instructed to not complete questions 3 through 5.","timeFrame":"Week 8 (or ET)"},{"measure":"Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)","description":"C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of \"Yes\" on \"Actual Attempt\"),preparatory acts toward imminent suicidal behavior (3)(\"Yes\" on \"Preparatory Acts or Behavior\"),suicidal ideation (4)(\"Yes\" on \"Wish to be dead\",\"Non-Specific Active Suicidal Thoughts\",\"Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)(\"Yes\" on \"Has subject engaged in Non-suicidal Self-Injurious Behavior\").","timeFrame":"Week 8 (or ET)"},{"measure":"Discontinuation-Emergent Signs and Symptoms (DESS)","description":"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms.","timeFrame":"Week 8 to 10 (or ET)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening).\n* Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of \\>= 20.\n* Clinical Global Impressions Scale-Severity (CGI-S) score of \\>= 4.\n\nExclusion Criteria:\n\n* Clinical instability (25% or greater increase/decrease in HAM-D 17 total score from screening to baseline).\n* Significant risk of suicide as assessed by clinician judgment, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call 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Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435."},{"pmid":"29140227","type":"DERIVED","citation":"Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15."},{"pmid":"26709542","type":"DERIVED","citation":"McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13."},{"pmid":"26644956","type":"DERIVED","citation":"McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015."},{"pmid":"25758058","type":"DERIVED","citation":"Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26."},{"pmid":"24571916","type":"DERIVED","citation":"Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26."},{"pmid":"23517291","type":"DERIVED","citation":"Liebowitz MR, Tourian KA, Hwang E, Mele L; Study 3362 Investigators. A double-blind, randomized, placebo-controlled study assessing the efficacy and tolerability of desvenlafaxine 10 and 50 mg/day in adult outpatients with major depressive disorder. BMC Psychiatry. 2013 Mar 22;13:94. doi: 10.1186/1471-244X-13-94."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-3362&StudyName=Study%20Evaluating%20Desvenlafaxine%20Succinate%20Sustained%20Release%20In%20Adults%20With%20Major%20Depressive%20Disorder"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 898 potential participants were screened for this study. 804 participants were enrolled and received single-blind placebo during the screening period prior to randomization.","groups":[{"id":"FG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"FG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"FG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"227"},{"groupId":"FG001","numSubjects":"228"},{"groupId":"FG002","numSubjects":"227"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"223"},{"groupId":"FG001","numSubjects":"226"},{"groupId":"FG002","numSubjects":"224"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"195"},{"groupId":"FG001","numSubjects":"198"},{"groupId":"FG002","numSubjects":"202"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"30"},{"groupId":"FG002","numSubjects":"25"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"Participant failed to return","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Investigator request","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"6"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"5"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"Randomized not treated","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"BG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"BG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"223"},{"groupId":"BG001","value":"226"},{"groupId":"BG002","value":"224"},{"groupId":"BG003","value":"673"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"41.75","spread":"12.85"},{"groupId":"BG001","value":"41.01","spread":"13.75"},{"groupId":"BG002","value":"42.47","spread":"13.47"},{"groupId":"BG003","value":"41.74","spread":"13.36"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"139"},{"groupId":"BG001","value":"135"},{"groupId":"BG002","value":"135"},{"groupId":"BG003","value":"409"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"84"},{"groupId":"BG001","value":"91"},{"groupId":"BG002","value":"89"},{"groupId":"BG003","value":"264"}]}]}]},{"title":"Hamilton Psychiatric Scale for Depression-17 item HAM-D17) total score","description":"HAM-D17 : a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"23.23","spread":"2.63"},{"groupId":"BG001","value":"22.83","spread":"2.26"},{"groupId":"BG002","value":"23.12","spread":"2.62"},{"groupId":"BG003","value":"23.06","spread":"2.51"}]}]}]},{"title":"Clinical Global Impressions Scale-Severity of Illness (CGI-S) Score","description":"CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.14","spread":"0.35"},{"groupId":"BG001","value":"4.14","spread":"0.34"},{"groupId":"BG002","value":"4.16","spread":"0.39"},{"groupId":"BG003","value":"4.14","spread":"0.36"}]}]}]},{"title":"Montgomery-Asberg Depression Rating Scale (MADRS) total score","description":"MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28.33","spread":"4.71"},{"groupId":"BG001","value":"27.59","spread":"4.49"},{"groupId":"BG002","value":"28.44","spread":"4.83"},{"groupId":"BG003","value":"28.12","spread":"4.69"}]}]}]},{"title":"HAM-D6 total score","description":"HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items associated with major depression and is a subset of the HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12.72","spread":"1.51"},{"groupId":"BG001","value":"12.77","spread":"1.41"},{"groupId":"BG002","value":"12.63","spread":"1.49"},{"groupId":"BG003","value":"12.71","spread":"1.47"}]}]}]},{"title":"Sheehan Disability Scale (SDS) Total Score","description":"SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities.Participant rates extent to which each of these domains are impaired by his/her symptoms using 10 point visual analog scale:(0=not at all impaired,10=extremely impaired) for total maximum score of 30.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"16.88","spread":"8.25"},{"groupId":"BG001","value":"16.42","spread":"8.37"},{"groupId":"BG002","value":"17.06","spread":"7.73"},{"groupId":"BG003","value":"16.78","spread":"8.12"}]}]}]},{"title":"World Health Organization 5-Item Well-Being Index (WHO-5)","description":"WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 ( 0= worst possible quality of life; 25=best possible quality of life).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7.39","spread":"4.80"},{"groupId":"BG001","value":"7.47","spread":"4.86"},{"groupId":"BG002","value":"7.06","spread":"4.26"},{"groupId":"BG003","value":"7.31","spread":"4.65"}]}]}]},{"title":"Participants with Sexual dysfunction","description":"Arizona Sexual Experiences Scale (ASEX) includes 5 questions that evaluate sexual function exclusively during week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items.","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58.8"},{"groupId":"BG001","value":"61.3"},{"groupId":"BG002","value":"65.8"},{"groupId":"BG003","value":"185.9"}]}]}]},{"title":"Participants with Columbia Suicide-Severity Rating Scale (C-SSRS) total score","description":"C-SSRS was mapped into Columbia Classification Algorithm of Suicide Assessment (C-CASA)(1-4) to prospectively assess whether participants experienced: completed suicide(1),suicide attempt(2),preparatory acts toward imminent suicidal behavior(3),suicidal ideation,any suicidal behavior and ideation(4).Participants with \"yes\" response were reported.","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Completed Suicide","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]},{"title":"Suicide Attempt","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]},{"title":"Preparatory acts toward imminent suicidal behavior","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]},{"title":"Suicidal ideation","categories":[{"measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"29"},{"groupId":"BG003","value":"97"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET)","description":"HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.","populationDescription":"Intent-To-Treat (ITT) Population:all randomly assigned participants with baseline primary efficacy evaluation, had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline and Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"OG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"226"},{"groupId":"OG002","value":"224"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.42","spread":"0.45"},{"groupId":"OG001","value":"-9.28","spread":"0.45"},{"groupId":"OG002","value":"-8.92","spread":"0.45"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.175","pValueComment":"A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.86","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.38","ciUpperLimit":"2.10"},{"groupIds":["OG000","OG002"],"groupDescription":"An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.421","pValueComment":"A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.51","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.73","ciUpperLimit":"1.75"}]},{"type":"SECONDARY","title":"Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)","description":"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.","populationDescription":"ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"OG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"226"},{"groupId":"OG002","value":"224"}]}],"classes":[{"title":"1=Very much improved","categories":[{"measurements":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"50"},{"groupId":"OG002","value":"55"}]}]},{"title":"2=Much improved","categories":[{"measurements":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"75"},{"groupId":"OG002","value":"53"}]}]},{"title":"3=Minimally improved","categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"64"}]}]},{"title":"4=No change","categories":[{"measurements":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"49"}]}]},{"title":"5=Minimally worse","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"}]}]},{"title":"6=Much worse","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"7=Very much worse","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.076","pValueComment":"In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"},{"groupIds":["OG000","OG002"],"groupDescription":"Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.204","pValueComment":"In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)","description":"CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.","populationDescription":"ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline and Week 8 (or ET )","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"OG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"226"},{"groupId":"OG002","value":"224"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.08","spread":"0.07"},{"groupId":"OG001","value":"-1.23","spread":"0.07"},{"groupId":"OG002","value":"-1.11","spread":"0.07"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.130","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.04","ciUpperLimit":"0.35"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.757","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.16","ciUpperLimit":"0.23"}]},{"type":"SECONDARY","title":"Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)","description":"MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).","populationDescription":"ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline and Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"OG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"224"},{"groupId":"OG002","value":"222"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.87","spread":"0.63"},{"groupId":"OG001","value":"-11.28","spread":"0.63"},{"groupId":"OG002","value":"-10.76","spread":"0.63"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.114","statisticalMethod":"ANCOVA","paramType":"Median Difference (Final Values)","paramValue":"1.41","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.34","ciUpperLimit":"3.16"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.316","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.89","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.85","ciUpperLimit":"2.64"}]},{"type":"SECONDARY","title":"Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)","description":"HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. 0=none/absent and 22=most severe.The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.","populationDescription":"ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline and Week 8 (or ET )","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"OG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"226"},{"groupId":"OG002","value":"224"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.75","spread":"0.27"},{"groupId":"OG001","value":"-5.49","spread":"0.27"},{"groupId":"OG002","value":"-5.19","spread":"0.27"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.054","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.74","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.01","ciUpperLimit":"1.50"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.253","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.44","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.32","ciUpperLimit":"1.20"}]},{"type":"SECONDARY","title":"Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)","description":"A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.","populationDescription":"ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"OG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"226"},{"groupId":"OG002","value":"224"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"91"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2415","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.254","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.86","ciUpperLimit":"1.83"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6169","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.102","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.75","ciUpperLimit":"1.61"}]},{"type":"SECONDARY","title":"Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)","description":"Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.","populationDescription":"ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"OG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"226"},{"groupId":"OG002","value":"224"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"52"},{"groupId":"OG002","value":"39"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.3667","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.236","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.78","ciUpperLimit":"1.96"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6509","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"0.894","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.55","ciUpperLimit":"1.45"}]},{"type":"SECONDARY","title":"Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)","description":"A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).","populationDescription":"ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"OG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"224"},{"groupId":"OG002","value":"222"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"95"},{"groupId":"OG002","value":"90"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.3893","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.182","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.81","ciUpperLimit":"1.73"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.5510","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.123","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.77","ciUpperLimit":"1.65"}]},{"type":"SECONDARY","title":"Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)","description":"CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.","populationDescription":"ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"OG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"226"},{"groupId":"OG002","value":"224"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"103"},{"groupId":"OG001","value":"125"},{"groupId":"OG002","value":"108"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis would be conducted with a logistic regression model with treatment as a factor.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0536","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.442","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.99","ciUpperLimit":"2.09"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis would be conducted with a logistic regression model with treatment as a factor.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6679","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.085","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.75","ciUpperLimit":"1.57"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations","description":"Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.","populationDescription":"PK population; data was insufficient examine the effect of demographic variables on the PK of desvenlafaxine. Parameter values were calculated for variables altering CL/F, AUC and V/F. Population parameters from nonlinear mixed effects modeling were not summarized as descriptive statistics.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"nanogram(ng)/mL","timeFrame":"Week 2, 4 and 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"OG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)","description":"SDS: a self-administered tools that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.","populationDescription":"ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation,had taken at least 1 dose of double-blind study drug,had at least 1 primary efficacy evaluation after first dose of double-blind drug.'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline and Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"OG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"226"},{"groupId":"OG002","value":"224"}]}],"classes":[{"title":"Total Score (n=220,223,219)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.63","spread":"0.48"},{"groupId":"OG001","value":"-4.09","spread":"0.48"},{"groupId":"OG002","value":"-3.78","spread":"0.49"}]}]},{"title":"Work/Studies Component(n=220,223,219)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.61","spread":"0.17"},{"groupId":"OG001","value":"-1.10","spread":"0.17"},{"groupId":"OG002","value":"-1.14","spread":"0.17"}]}]},{"title":"Social Life and Leisure Activities(n=222,224,221)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.08","spread":"0.18"},{"groupId":"OG001","value":"-1.58","spread":"0.17"},{"groupId":"OG002","value":"-1.36","spread":"0.18"}]}]},{"title":"Family Life/Home Responsibilities (n=222,224,221)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.98","spread":"0.17"},{"groupId":"OG001","value":"-1.43","spread":"0.17"},{"groupId":"OG002","value":"-1.20","spread":"0.17"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for \"total score\".","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.033","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final 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\"family life/home responsibilities component score\".","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.056","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.45","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.01","ciUpperLimit":"0.91"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for \"family life/home responsibilities component score\".","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.355","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.24","ciUpperLimit":"0.68"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)","description":"WHO-5 evaluates 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WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).","populationDescription":"ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline and Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"OG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"224"},{"groupId":"OG002","value":"221"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.96","spread":"0.36"},{"groupId":"OG001","value":"4.51","spread":"0.35"},{"groupId":"OG002","value":"3.73","spread":"0.36"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-1.54","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.53","ciUpperLimit":"-0.56"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.129","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-0.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.75","ciUpperLimit":"0.22"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)","description":"ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week were instructed to not complete questions 3 through 5.","populationDescription":"The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"OG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"222"},{"groupId":"OG002","value":"220"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52.0"},{"groupId":"OG001","value":"48.6"},{"groupId":"OG002","value":"59.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.3097","statisticalMethod":"Regression, Linear","paramType":"Odds Ratio (OR)","paramValue":"0.800","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.52","ciUpperLimit":"1.23"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2794","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.272","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.82","ciUpperLimit":"1.97"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)","description":"C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of \"Yes\" on \"Actual Attempt\"),preparatory acts toward imminent suicidal behavior (3)(\"Yes\" on \"Preparatory Acts or Behavior\"),suicidal ideation (4)(\"Yes\" on \"Wish to be dead\",\"Non-Specific Active Suicidal Thoughts\",\"Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)(\"Yes\" on \"Has subject engaged in Non-suicidal Self-Injurious Behavior\").","populationDescription":"The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"OG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"226"},{"groupId":"OG002","value":"224"}]}],"classes":[{"title":"Completed suicide","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Suicide attempt","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Preparatory acts toward imminent suicidal behavior","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Suicidal ideation","categories":[{"measurements":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"45"}]}]},{"title":"Any suicidal behavior and/or ideation","categories":[{"measurements":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"45"}]}]},{"title":"Self-injurious behavior, no suicidal intent","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Discontinuation-Emergent Signs and Symptoms (DESS)","description":"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms.","populationDescription":"Analysis included completers for exposure (those whose exposure duration was at least 53 days) among safety population. 'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"Week 8 to 10 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET)."},{"id":"OG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"226"},{"groupId":"OG002","value":"224"}]}],"classes":[{"title":"Week 8 (or ET) (n=190,194,191)","categories":[{"measurements":[{"groupId":"OG000","value":"0.72","spread":"1.81"},{"groupId":"OG001","value":"0.80","spread":"1.78"},{"groupId":"OG002","value":"0.83","spread":"2.05"}]}]},{"title":"Week 9 ( or ET + 1 week) (n=178,185,186)","categories":[{"measurements":[{"groupId":"OG000","value":"1.26","spread":"2.78"},{"groupId":"OG001","value":"1.08","spread":"2.31"},{"groupId":"OG002","value":"1.98","spread":"3.29"}]}]},{"title":"Week 10 (or ET + 2 weeks (n=170,182,182)","categories":[{"measurements":[{"groupId":"OG000","value":"0.90","spread":"2.30"},{"groupId":"OG001","value":"0.91","spread":"2.24"},{"groupId":"OG002","value":"1.07","spread":"2.50"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.805","statisticalMethod":"t-test, 2 sided","ciNumSides":"TWO_SIDED"},{"groupIds":["OG000","OG001"],"groupDescription":"To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.805","statisticalMethod":"t-test, 2 sided","ciNumSides":"TWO_SIDED"},{"groupIds":["OG000","OG001"],"groupDescription":"To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.978","statisticalMethod":"t-test, 2 sided","ciNumSides":"TWO_SIDED"},{"groupIds":["OG000","OG002"],"groupDescription":"To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.805","statisticalMethod":"Regression, Logistic","ciNumSides":"TWO_SIDED"},{"groupIds":["OG000","OG002"],"groupDescription":"To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.154","statisticalMethod":"t-test, 2 sided","ciNumSides":"TWO_SIDED"},{"groupIds":["OG000","OG002"],"groupDescription":"To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.805","statisticalMethod":"t-test, 2 sided","ciNumSides":"TWO_SIDED"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","description":"The same event may appear as both an AE and a SAE. 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An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).","seriousNumAffected":3,"seriousNumAtRisk":223,"otherNumAffected":166,"otherNumAtRisk":223},{"id":"EG001","title":"DVS SR 10 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.","seriousNumAffected":1,"seriousNumAtRisk":226,"otherNumAffected":168,"otherNumAtRisk":226},{"id":"EG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET.","seriousNumAffected":1,"seriousNumAtRisk":224,"otherNumAffected":170,"otherNumAtRisk":224}],"seriousEvents":[{"term":"Non-cardiac chest pain","organSystem":"General 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disorders","sourceVocabulary":"MedDRA","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":223},{"groupId":"EG001","numAffected":1,"numAtRisk":226},{"groupId":"EG002","numAffected":0,"numAtRisk":224}]},{"term":"Epididymitis","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":223},{"groupId":"EG001","numAffected":0,"numAtRisk":226},{"groupId":"EG002","numAffected":0,"numAtRisk":224}]},{"term":"Pulmonary embolism","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":223},{"groupId":"EG001","numAffected":0,"numAtRisk":226},{"groupId":"EG002","numAffected":1,"numAtRisk":224}]}],"otherEvents":[{"term":"Leukocytosis","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":223},{"groupId":"EG001","numAffected":0,"numAtRisk":226},{"groupId":"EG002","numAffected":0,"numAtRisk":224}]},{"term":"Lymphadenopathy","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":223},{"groupId":"EG001","numAffected":1,"numAtRisk":226},{"groupId":"EG002","numAffected":0,"numAtRisk":224}]},{"term":"Polycythaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":223},{"groupId":"EG001","numAffected":1,"numAtRisk":226},{"groupId":"EG002","numAffected":0,"numAtRisk":224}]},{"term":"Atrioventricular block first degree","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":223},{"groupId":"EG001","numAffected":0,"numAtRisk":226},{"groupId":"EG002","numAffected":1,"numAtRisk":224}]},{"term":"Bradycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":223},{"groupId":"EG001","numAffected":1,"numAtRisk":226},{"groupId":"EG002","numAffected":0,"numAtRisk":224}]},{"term":"Cardiac hypertrophy","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":223},{"groupId":"EG001","numAffected":1,"numAtRisk":226},{"groupId":"EG002","numAffected":0,"numAtRisk":224}]},{"term":"Palpitations","organSystem":"Cardiac 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