{"protocolSection":{"identificationModule":{"nctId":"NCT01371708","orgStudyIdInfo":{"id":"B2061030"},"secondaryIdInfos":[{"id":"3151A6-3344","type":"OTHER","domain":"Alias Study Number"},{"id":"2008-001876-67","type":"EUDRACT_NUMBER"},{"id":"2008","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2008"}],"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD","officialTitle":"A 6-month, Open-label, Multi-center, Flexible Dose Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability And Efficacy Of Desvenlafaxine Succinate Sustained Release (Dvs Sr) Tablets In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2017-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-02-02","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2016-04-22","type":"ACTUAL"},"completionDateStruct":{"date":"2016-04-22","type":"ACTUAL"},"studyFirstSubmitDate":"2011-06-09","studyFirstSubmitQcDate":"2011-06-10","studyFirstPostDateStruct":{"date":"2011-06-13","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-10-14","resultsFirstSubmitQcDate":"2016-10-14","resultsFirstPostDateStruct":{"date":"2016-12-08","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-06-28","lastUpdatePostDateStruct":{"date":"2017-07-27","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients with Major Depressive Disorder (MDD)."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Major Depressive Disorder","MDD","Depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":283,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Desvenlafaxine Succinate Sustained-Release","type":"EXPERIMENTAL","interventionNames":["Drug: DVS SR"]}],"interventions":[{"type":"DRUG","name":"DVS SR","description":"Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator","armGroupLabels":["Desvenlafaxine Succinate Sustained-Release"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)","description":"A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030"},{"measure":"Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)","description":"A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030"}],"secondaryOutcomes":[{"measure":"Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases","description":"The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \\<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030"},{"measure":"Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)","description":"The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \\<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030"},{"measure":"Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases","description":"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating \"normal, not at all ill\" and 7, \"among the most extremely ill patients.\" Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030"},{"measure":"Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)","description":"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating \"normal, not at all ill\" and 7, \"among the most extremely ill patients.\" Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030"},{"measure":"Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases","description":"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing \"very much improved\" and 7 representing \"very much worse\"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030"},{"measure":"Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)","description":"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing \"very much improved\" and 7 representing \"very much worse\"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030"},{"measure":"Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases","description":"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing \"very much improved\" and 7 representing \"very much worse\"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030"},{"measure":"Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)","description":"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing \"very much improved\" and 7 representing \"very much worse\"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030"},{"measure":"Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases","description":"Remission on the CDRS-R was defined as a CDRS-R score \\<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030"},{"measure":"Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)","description":"Remission on the CDRS-R was defined as a CDRS-R score \\<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Completed study B2061032 and who in the investigator's opinion, would benefit from long term treatment with DVS SR\n* Willingness and ability to comply with scheduled visits, treatment plan, and procedures\n\nExclusion Criteria:\n\n* Requires precaution against suicide\n* Not in generally healthy medical condition\n* Poor compliance with study drug or study procedures during participation in study B2061032","healthyVolunteers":false,"sex":"ALL","minimumAge":"7 Years","maximumAge":"17 Years","stdAges":["CHILD"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"The University Of Alabama At Birmingham, Office Of Psychiatric 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Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials. CNS Spectr. 2019 Oct;24(5):496-506. doi: 10.1017/S1092852918001128."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2061030&StudyName=A%206-Month%20Extension%20Study%20To%20The%20B2061032%20Study%20To%20Evaluate%20The%20Safety%2C%20Tolerability%2C%20And%20Efficacy%20Of%20DVS%20SR%20In%20The%20Treatment%20Of"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 304 participants completed study B2061032, 283 of whom were enrolled in the current extension study, B2061030, and 281 received treatment.","groups":[{"id":"FG000","title":"Placebo/DVS-SR","description":"Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"FG001","title":"DVS-SR, Low Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"FG002","title":"DVS-SR, High Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"92"},{"groupId":"FG001","numSubjects":"93"},{"groupId":"FG002","numSubjects":"98"}]},{"type":"Received Treatment","achievements":[{"groupId":"FG000","numSubjects":"91"},{"groupId":"FG001","numSubjects":"93"},{"groupId":"FG002","numSubjects":"97"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"66"},{"groupId":"FG001","numSubjects":"63"},{"groupId":"FG002","numSubjects":"59"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"30"},{"groupId":"FG002","numSubjects":"39"}]}],"dropWithdraws":[{"type":"Insufficient clinical response","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"7"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"No longer willing to participate","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"13"}]},{"type":"Medication error/not related to AE","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"12"}]},{"type":"Started but did not receive treatment","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All participants who received at least 1 dose of study drug","groups":[{"id":"BG000","title":"Placebo/DVS-SR","description":"Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"BG001","title":"DVS-SR, Low Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"BG002","title":"DVS-SR, High Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"91"},{"groupId":"BG001","value":"93"},{"groupId":"BG002","value":"97"},{"groupId":"BG003","value":"281"}]}],"measures":[{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"7 to 11 years","categories":[{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"33"},{"groupId":"BG003","value":"87"}]}]},{"title":"12 to 17 years","categories":[{"measurements":[{"groupId":"BG000","value":"63"},{"groupId":"BG001","value":"67"},{"groupId":"BG002","value":"64"},{"groupId":"BG003","value":"194"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"52"},{"groupId":"BG002","value":"60"},{"groupId":"BG003","value":"155"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"41"},{"groupId":"BG002","value":"37"},{"groupId":"BG003","value":"126"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}]}]},{"title":"Black or African American","categories":[{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"28"},{"groupId":"BG003","value":"71"}]}]},{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"62"},{"groupId":"BG001","value":"65"},{"groupId":"BG002","value":"60"},{"groupId":"BG003","value":"187"}]}]},{"title":"Other","categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"21"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)","description":"A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.","populationDescription":"All participants who received at least 1 dose of study drug in study B2061030","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030","groups":[{"id":"OG000","title":"Placebo/DVS-SR","description":"Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"OG001","title":"DVS-SR, Low Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"OG002","title":"DVS-SR, High Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"93"},{"groupId":"OG002","value":"97"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"78.0"},{"groupId":"OG001","value":"73.1"},{"groupId":"OG002","value":"71.1"}]}]}]},{"type":"PRIMARY","title":"Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)","description":"A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.","populationDescription":"All participants who received at least 1 dose of study drug in study B2061030","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030","groups":[{"id":"OG000","title":"Combination Group","description":"Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"281"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"74.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases","description":"The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \\<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","populationDescription":"All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030","groups":[{"id":"OG000","title":"Placebo/DVS-SR","description":"Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"OG001","title":"DVS-SR, Low Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"OG002","title":"DVS-SR, High Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"56"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.79","spread":"12.05"},{"groupId":"OG001","value":"-10.72","spread":"10.80"},{"groupId":"OG002","value":"-8.57","spread":"13.01"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)","description":"The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \\<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","populationDescription":"All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030","groups":[{"id":"OG000","title":"Combination Group","description":"Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"176"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.63","spread":"12.03"}]}]}]},{"type":"SECONDARY","title":"Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases","description":"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating \"normal, not at all ill\" and 7, \"among the most extremely ill patients.\" Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","populationDescription":"All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030","groups":[{"id":"OG000","title":"Placebo/DVS-SR","description":"Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"OG001","title":"DVS-SR, Low Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"OG002","title":"DVS-SR, High Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"56"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.02","spread":"1.18"},{"groupId":"OG001","value":"-1.44","spread":"1.12"},{"groupId":"OG002","value":"-0.70","spread":"1.37"}]}]}]},{"type":"SECONDARY","title":"Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)","description":"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating \"normal, not at all ill\" and 7, \"among the most extremely ill patients.\" Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","populationDescription":"All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030","groups":[{"id":"OG000","title":"Combination Group","description":"Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"176"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.05","spread":"1.26"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases","description":"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing \"very much improved\" and 7 representing \"very much worse\"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","populationDescription":"All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030","groups":[{"id":"OG000","title":"Placebo/DVS-SR","description":"Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"OG001","title":"DVS-SR, Low Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"OG002","title":"DVS-SR, High Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"56"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"87.3"},{"groupId":"OG001","value":"94.7"},{"groupId":"OG002","value":"89.3"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)","description":"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing \"very much improved\" and 7 representing \"very much worse\"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","populationDescription":"All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030","groups":[{"id":"OG000","title":"Combination Group","description":"Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"176"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"90.3"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases","description":"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing \"very much improved\" and 7 representing \"very much worse\"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","populationDescription":"All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030","groups":[{"id":"OG000","title":"Placebo/DVS-SR","description":"Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"OG001","title":"DVS-SR, Low Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"OG002","title":"DVS-SR, High Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"56"}]}],"classes":[{"title":"Week 26: Very much improved","categories":[{"measurements":[{"groupId":"OG000","value":"54.0"},{"groupId":"OG001","value":"73.7"},{"groupId":"OG002","value":"53.6"}]}]},{"title":"Week 26: Much improved","categories":[{"measurements":[{"groupId":"OG000","value":"33.3"},{"groupId":"OG001","value":"21.1"},{"groupId":"OG002","value":"35.7"}]}]},{"title":"Week 26: Minimally improved","categories":[{"measurements":[{"groupId":"OG000","value":"9.5"},{"groupId":"OG001","value":"5.3"},{"groupId":"OG002","value":"10.7"}]}]},{"title":"Week 26: No change","categories":[{"measurements":[{"groupId":"OG000","value":"1.6"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"}]}]},{"title":"Week 26: Minimally worse","categories":[{"measurements":[{"groupId":"OG000","value":"1.6"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"}]}]},{"title":"Week 26: Much worse","categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"}]}]},{"title":"Week 26: Very much worse","categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)","description":"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing \"very much improved\" and 7 representing \"very much worse\"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.","populationDescription":"All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030","groups":[{"id":"OG000","title":"Combination Group","description":"Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"176"}]}],"classes":[{"title":"Week 26: Very much improved","categories":[{"measurements":[{"groupId":"OG000","value":"60.2"}]}]},{"title":"Week 26: Much improved","categories":[{"measurements":[{"groupId":"OG000","value":"30.1"}]}]},{"title":"Week 26: Minimally improved","categories":[{"measurements":[{"groupId":"OG000","value":"8.5"}]}]},{"title":"Week 26: No change","categories":[{"measurements":[{"groupId":"OG000","value":"0.6"}]}]},{"title":"Week 26: Minimally worse","categories":[{"measurements":[{"groupId":"OG000","value":"0.6"}]}]},{"title":"Week 26: Much worse","categories":[{"measurements":[{"groupId":"OG000","value":"0.0"}]}]},{"title":"Week 26: Very much worse","categories":[{"measurements":[{"groupId":"OG000","value":"0.0"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases","description":"Remission on the CDRS-R was defined as a CDRS-R score \\<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.","populationDescription":"All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030","groups":[{"id":"OG000","title":"Placebo/DVS-SR","description":"Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"OG001","title":"DVS-SR, Low Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."},{"id":"OG002","title":"DVS-SR, High Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"56"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"73.0"},{"groupId":"OG001","value":"89.5"},{"groupId":"OG002","value":"75.0"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)","description":"Remission on the CDRS-R was defined as a CDRS-R score \\<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.","populationDescription":"All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030","groups":[{"id":"OG000","title":"Combination Group","description":"Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"176"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"79.0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"3","timeFrame":"From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,","eventGroups":[{"id":"EG000","title":"Placebo/DVS-SR","description":"Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.","seriousNumAffected":4,"seriousNumAtRisk":91,"otherNumAffected":60,"otherNumAtRisk":91},{"id":"EG001","title":"DVS-SR, Low Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing(20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.","seriousNumAffected":6,"seriousNumAtRisk":93,"otherNumAffected":57,"otherNumAtRisk":93},{"id":"EG002","title":"DVS-SR, High Dose/DVS-SR","description":"Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.","seriousNumAffected":3,"seriousNumAtRisk":97,"otherNumAffected":58,"otherNumAtRisk":97},{"id":"EG003","title":"Combination Group","description":"Combination of 3 groups of participants from previous study B2061032 received DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.","seriousNumAffected":13,"seriousNumAtRisk":281,"otherNumAffected":175,"otherNumAtRisk":281}],"seriousEvents":[{"term":"Femur fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v19","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":93},{"groupId":"EG002","numAffected":1,"numAtRisk":97},{"groupId":"EG003","numAffected":1,"numAtRisk":281}]},{"term":"Ketoacidosis","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v19","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":93},{"groupId":"EG002","numAffected":0,"numAtRisk":97},{"groupId":"EG003","numAffected":1,"numAtRisk":281}]},{"term":"Generalised tonic-clonic seizure","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v19","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":93},{"groupId":"EG002","numAffected":0,"numAtRisk":97},{"groupId":"EG003","numAffected":1,"numAtRisk":281}]},{"term":"Aggression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v19","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":93},{"groupId":"EG002","numAffected":0,"numAtRisk":97},{"groupId":"EG003","numAffected":1,"numAtRisk":281}]},{"term":"Agitation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v19","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":93},{"groupId":"EG002","numAffected":0,"numAtRisk":97},{"groupId":"EG003","numAffected":2,"numAtRisk":281}]},{"term":"Hallucination, auditory","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v19","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":93},{"groupId":"EG002","numAffected":0,"numAtRisk":97},{"groupId":"EG003","numAffected":1,"numAtRisk":281}]},{"term":"Initial insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v19","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":91},{"groupId":"EG001","numAffected":1,"numAtRisk":93},{"groupId":"EG002","numAffected":0,"numAtRisk":97},{"groupId":"EG003","numAffected":1,"numAtRisk":281}]},{"term":"Major depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v19","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":91},{"groupId":"EG001","numAffected":0,"numAtRisk":93},{"groupId":"EG002","numAffected":0,"numAtRisk":97},{"groupId":"EG003","numAffected":1,"numAtRisk":281}]},{"term":"Pyromania","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 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