{"protocolSection":{"identificationModule":{"nctId":"NCT01485887","orgStudyIdInfo":{"id":"B2411264"},"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)","officialTitle":"A Open-label Long-term Extension Study To Evaluate The Safety And Efficacy Of Venlafaxine Er In Adult Outpatients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2021-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-01"},"primaryCompletionDateStruct":{"date":"2014-01","type":"ACTUAL"},"completionDateStruct":{"date":"2014-01","type":"ACTUAL"},"studyFirstSubmitDate":"2011-11-29","studyFirstSubmitQcDate":"2011-12-02","studyFirstPostDateStruct":{"date":"2011-12-06","type":"ESTIMATED"},"resultsFirstSubmitDate":"2015-01-09","resultsFirstSubmitQcDate":"2015-05-13","resultsFirstPostDateStruct":{"date":"2015-05-15","type":"ESTIMATED"},"lastUpdateSubmitDate":"2021-01-26","lastUpdatePostDateStruct":{"date":"2021-01-28","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer's Upjohn has merged with Mylan to form Viatris Inc.","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate in this study. This study consists of 10 month treatment phase and 1-3 week tapering phase. The 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication dosing."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Venlafaxine ER","long-term extension","Japan"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":50,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Venlafaxine ER","type":"EXPERIMENTAL","interventionNames":["Drug: Venlafaxine ER"]}],"interventions":[{"type":"DRUG","name":"Venlafaxine ER","description":"Treatment phase: 10 months (75-225 mg/day), oral administration Tapering phase: 1-3 weeks (stepwise dose reduction: 150-37.5 mg/day), oral administration","armGroupLabels":["Venlafaxine ER"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)","description":"Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months"},{"measure":"Number of Participants With Clinical Significant Vital Changes","description":"Clinical significant changes were pre-defined for systolic blood pressure (SBP), diastolic blood pressure (DBP) , and pulse rate (PR). An average value of 3 measurements in each visit meeting the following criteria for 3 consecutive visits was determined as clinical siginificant changes: DBP \\>= 90 mmHg with change from the baseline \\>= 10 mmHg; SBP \\>= 140 mmHg with change from the baseline \\>= 20 mmHg; PR \\>= 100 bpm with change from the baseline \\>= 15 bpm.","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months"},{"measure":"Number of Participants With Clinical Significant Laboratory Tests Changes","description":"Clinical significant changes were pre-defined for each laboratory test based on the criteria: Red Blood Cell Count \\<0.8 x lower limit normal (LLN); Lymphocytes (%) \\<0.8 x LLN; Eosinophils (%) \\>1.2 x upper limit normal (ULN); Total Bilirubin \\>1.5 x ULN; Alanine Aminotransferase (ALT) \\>3.0 x ULN; Gamma glutamyl transferase (GGT) \\>3.0 x ULN; Uric Acid \\>1.2 x ULN; Cholesterol \\>1.3 x ULN; Low density lipoprotein (LDL) cholesterol \\>1.2 x ULN; Triglycerides \\>1.3 x ULN; Glucose \\>1.5 x ULN; Urine Glucose \\[qualitative (Qual)\\] \\>=1; Urine Protein (Qual) \\>=1; Urine Blood/Hemoglobin (Hgb) (Qual) \\>=1.","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months"},{"measure":"Number of Participants With Clinical Significant Electrocardiogram (ECG) Changes","description":"Clinically significant ECG findings included: corrected QT (QTc), QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF)\\> 450 millisecond (ms), \\>480 ms, and \\>500 ms respsctively, change from baseline in QTc, QTcB, and QTcF \\>= 30 ms, and \\>= 60 ms, respectively.","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months"},{"measure":"Number of Participants With no at Baseline and Yes at Any Post Baseline for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories","description":"C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months"}],"secondaryOutcomes":[{"measure":"Change From Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) at Each Post Baseline Time Point","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 (8 items) or 0 to 4 (9 items), and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline.","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44"},{"measure":"Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Each Post Baseline Time Point","description":"CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at observation minus mean score at baseline.","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44"},{"measure":"Mean Clinical Global Impression - Improvement (CGI-I) Score at Each Post Baseline Time Point","description":"CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 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. Scores above 4 reflect worsening of illness state as compared to baseline.","timeFrame":"Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44"},{"measure":"Change From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) at Each Post Baseline Time Point","description":"QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3, and the total score ranges from 0 to 27. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline.","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 12, 24, 44"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Outpatients who have completed 8 weeks double-blind study (B2411263), without major protocol violations or tolerability concerns in the opinion of the investigator.\n\nExclusion Criteria:\n\n* Clinically important abnormalities on baseline (Week 8 of the double-blind study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before Week 8 in the previous double-blind study.\n* Significant risk of suicide based on clinical judgment.\n* Use of prohibited treatments","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Nippon Medical School Chiba Hokusoh Hospital","city":"Inzai","state":"Chiba","zip":"270-1694","country":"Japan","geoPoint":{"lat":35.83479,"lon":140.16361}},{"facility":"Nakamoto Clinic","city":"Noda","state":"Chiba","zip":"278-0033","country":"Japan","geoPoint":{"lat":35.94897,"lon":139.86793}},{"facility":"Stress Care Yoshimura Clinic","city":"Fukuoka","state":"Fukuoka","zip":"810-0041","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"Hatakeyama Clinic","city":"Kitakyushu","state":"Fukuoka","zip":"802-0064","country":"Japan","geoPoint":{"lat":33.85181,"lon":130.85034}},{"facility":"Shiranui Hospital","city":"Omuta","state":"Fukuoka","zip":"836-0004","country":"Japan","geoPoint":{"lat":33.03333,"lon":130.45}},{"facility":"Fujikawa Clinic","city":"Hatsukaichi","state":"Hiroshima","zip":"738-0023","country":"Japan","geoPoint":{"lat":34.35,"lon":132.33333}},{"facility":"Takahashi Psychiatric Clinic","city":"Ashiya","state":"Hyōgo","zip":"659-0093","country":"Japan","geoPoint":{"lat":34.72807,"lon":135.30264}},{"facility":"Ikeuchi Psycho Induced Internal Med.Clinic","city":"Kobe","state":"Hyōgo","zip":"655-0037","country":"Japan","geoPoint":{"lat":34.6913,"lon":135.183}},{"facility":"National Hospital Organization Kanazawa Medical Center","city":"Kanazawa","state":"Ishikawa-ken","zip":"920-8650","country":"Japan","geoPoint":{"lat":36.6,"lon":136.61667}},{"facility":"Medical Corporation Seishinkai Kishiro Mental Clinic","city":"Kawasaki","state":"Kanagawa","zip":"214-0014","country":"Japan","geoPoint":{"lat":35.52056,"lon":139.71722}},{"facility":"Yutaka Clinic","city":"Sagamihara-shi","state":"Kanagawa","zip":"252-0303","country":"Japan"},{"facility":"Tawara Clinic","city":"Yokohama","state":"Kanagawa","zip":"221-0835","country":"Japan","geoPoint":{"lat":35.43333,"lon":139.65}},{"facility":"Shioiri Mental Clinic","city":"Yokosuka","state":"Kanagawa","zip":"238-0042","country":"Japan","geoPoint":{"lat":35.28361,"lon":139.66722}},{"facility":"Shibamoto Clinic","city":"Osakasayama-shi","state":"Osaka","zip":"589-0011","country":"Japan"},{"facility":"Suzuki Hospital","city":"Adachi-ku","state":"Tokyo","zip":"120-0033","country":"Japan"},{"facility":"Sangenjaya Nakamura Mental Clinic","city":"Setagaya-ku","state":"Tokyo","zip":"154-0004","country":"Japan"},{"facility":"Omotesando Mental Clinic","city":"Shibuya-ku","state":"Tokyo","zip":"150-0001","country":"Japan"},{"facility":"Maynds Tower Mental Clinic","city":"Shibuya-ku","state":"Tokyo","zip":"151-0053","country":"Japan"},{"facility":"Tokyo Kosei Nenkin Hospital","city":"Shinjuku-ku","state":"Tokyo","zip":"162-8543","country":"Japan"},{"facility":"Himorogi Psychiatric Institute","city":"Toshima-ku","state":"Tokyo","zip":"170-0002","country":"Japan"},{"facility":"Tenjin Mental Clinic","city":"Fukuoka","zip":"810-0004","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"Stress Care Yoshimura Clinic","city":"Fukuoka","zip":"810-0041","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"Kuranari Psychiatry Clinic","city":"Fukuoka","zip":"810-0801","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"Medical Corporation Toyokokai Tawara Clinic","city":"Kanagawa","zip":"221-0835","country":"Japan","geoPoint":{"lat":37.58333,"lon":139.91667}},{"facility":"Sagaarashiyama-Tanaka Clinic","city":"Kyoto","zip":"616-8421","country":"Japan","geoPoint":{"lat":35.02107,"lon":135.75385}}]},"referencesModule":{"references":[{"pmid":"26513202","type":"DERIVED","citation":"Higuchi T, Kamijima K, Nakagome K, Itamura R, Asami Y, Kuribayashi K, Imaeda T. A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan. Int Clin Psychopharmacol. 2016 Jan;31(1):8-19. doi: 10.1097/YIC.0000000000000105."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2411264&StudyName=Venlafaxine%20ER%20Long-Term%20Extension%20Study%20for%20Major%20Depressive%20Disorder%20%28MDD%29"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants who have completed the week 8 visit in the preceding double-blind study B2411263 (NCT01441440) were eligible to participate in this study.","groups":[{"id":"FG000","title":"Venlafaxine ER 75-225 mg/Day Flexible","description":"Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"50"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"38"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"12"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"8"}]},{"type":"Deterioration of primary disease","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Primary disease markedly improved","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Venlafaxine ER 75-225 mg/Day Flexible","description":"Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"50"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"43.7","spread":"13.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"FEMALE","measurements":[{"groupId":"BG000","value":"26"}]},{"title":"MALE","measurements":[{"groupId":"BG000","value":"24"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)","description":"Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.","populationDescription":"Participants who recieved at least one dose of the study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months","groups":[{"id":"OG000","title":"Venlafaxine ER 75-225 mg/Day Flexible","description":"Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"}]}],"classes":[{"title":"Adverse events (AEs)","categories":[{"measurements":[{"groupId":"OG000","value":"49"}]}]},{"title":"Serious adverse events (SAEs)","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Clinical Significant Vital Changes","description":"Clinical significant changes were pre-defined for systolic blood pressure (SBP), diastolic blood pressure (DBP) , and pulse rate (PR). An average value of 3 measurements in each visit meeting the following criteria for 3 consecutive visits was determined as clinical siginificant changes: DBP \\>= 90 mmHg with change from the baseline \\>= 10 mmHg; SBP \\>= 140 mmHg with change from the baseline \\>= 20 mmHg; PR \\>= 100 bpm with change from the baseline \\>= 15 bpm.","populationDescription":"Participants who received at least one dose of the study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months","groups":[{"id":"OG000","title":"Venlafaxine ER 75-225 mg/Day Flexible","description":"Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"}]}],"classes":[{"title":"Systoloc blood pressure (SBP)","categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"Diastolic bloodpressure (DBP)","categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]},{"title":"Pulse rate","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Clinical Significant Laboratory Tests Changes","description":"Clinical significant changes were pre-defined for each laboratory test based on the criteria: Red Blood Cell Count \\<0.8 x lower limit normal (LLN); Lymphocytes (%) \\<0.8 x LLN; Eosinophils (%) \\>1.2 x upper limit normal (ULN); Total Bilirubin \\>1.5 x ULN; Alanine Aminotransferase (ALT) \\>3.0 x ULN; Gamma glutamyl transferase (GGT) \\>3.0 x ULN; Uric Acid \\>1.2 x ULN; Cholesterol \\>1.3 x ULN; Low density lipoprotein (LDL) cholesterol \\>1.2 x ULN; Triglycerides \\>1.3 x ULN; Glucose \\>1.5 x ULN; Urine Glucose \\[qualitative (Qual)\\] \\>=1; Urine Protein (Qual) \\>=1; Urine Blood/Hemoglobin (Hgb) (Qual) \\>=1.","populationDescription":"Participants with at least one observation of the given laboratory test while on study treatment or during lag time.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months","groups":[{"id":"OG000","title":"Venlafaxine ER 75-225 mg/Day Flexible","description":"Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"49"}]}],"classes":[{"title":"Red Blood Cell Count < 0.8xLLN","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Lymphocytes (%) < 0.8xLLN","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"Eosinophils (%) > 1.2xULN","categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"Total Bilirubin > 1.5xULN","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"ALT > 3.0xULN","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"GGT > 3.0xULN","categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]},{"title":"Uric Acid > 1.2xULN","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Cholesterol > 1.3xULN","categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]},{"title":"LDL Cholestero l> 1.2xULN","categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}]},{"title":"Triglycerides > 1.3xULN","categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}]},{"title":"Glucose > 1.5xULN","categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"Urine Glucose (Qual) >= 1","categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"Urine Protein (Qual) >= 1","categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"Urine Blood/Hgb(Qual) >= 1","categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Clinical Significant Electrocardiogram (ECG) Changes","description":"Clinically significant ECG findings included: corrected QT (QTc), QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF)\\> 450 millisecond (ms), \\>480 ms, and \\>500 ms respsctively, change from baseline in QTc, QTcB, and QTcF \\>= 30 ms, and \\>= 60 ms, respectively.","populationDescription":"Participants with at least one observation of the electrocardiogram while on study treatment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months","groups":[{"id":"OG000","title":"Venlafaxine ER 75-225 mg/Day Flexible","description":"Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"49"}]}],"classes":[{"title":"QT Interval > 450 ms","categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}]},{"title":"QT Interval > 480 ms","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"QT Interval > 500 ms","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"QTcB Interval > 450 ms","categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}]},{"title":"QTcB Interval > 480 ms","categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]},{"title":"QTcB Interval > 500 ms","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"QTcF Interval > 450 ms","categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}]},{"title":"QTcF Interval > 480 ms","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"QTcF Interval > 500 ms","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"QT Interval increase from baseline >= 30 ms","categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}]},{"title":"QT Interval increase from baseline >= 60 ms","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"QTcB Interval increase from baseline >= 30 ms","categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}]},{"title":"QTcB Interval increase from baseline >= 60 ms","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"QTcF Interval increase from baseline >= 30 ms","categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]},{"title":"QTcF Interval increase from baseline >= 60 ms","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With no at Baseline and Yes at Any Post Baseline for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories","description":"C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.","populationDescription":"Participants who received at least one dose of the study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months","groups":[{"id":"OG000","title":"Venlafaxine ER 75-225 mg/Day Flexible","description":"Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"}]}],"classes":[{"title":"Completed suicide","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Suicide attempt","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Preparatory acts toward imminent suicidal behavior","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Suicide ideation","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Self-injurious behavior, no suicidal intent","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) at Each Post Baseline Time Point","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 (8 items) or 0 to 4 (9 items), and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline.","populationDescription":"Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44","groups":[{"id":"OG000","title":"Venlafaxine ER 75-225 mg/Day Flexible","description":"Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"}]}],"classes":[{"title":"Week 1 (n=50)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.0","spread":"2.00"}]}]},{"title":"Week 2 (n=50)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.5","spread":"3.47"}]}]},{"title":"Week 3 (n=50)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.2","spread":"4.76"}]}]},{"title":"Week 4 (n=50)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.9","spread":"4.55"}]}]},{"title":"Week 6 (n=47)","categories":[{"measurements":[{"groupId":"OG000","value":"-3.4","spread":"4.39"}]}]},{"title":"Week 8 (n=48)","categories":[{"measurements":[{"groupId":"OG000","value":"-3.9","spread":"4.61"}]}]},{"title":"Week 12 (n=47)","categories":[{"measurements":[{"groupId":"OG000","value":"-4.1","spread":"5.41"}]}]},{"title":"Week 16 (n=46)","categories":[{"measurements":[{"groupId":"OG000","value":"-4.4","spread":"7.06"}]}]},{"title":"Week 20 (n=45)","categories":[{"measurements":[{"groupId":"OG000","value":"-6.2","spread":"4.93"}]}]},{"title":"Week 24 (n=44)","categories":[{"measurements":[{"groupId":"OG000","value":"-5.7","spread":"5.08"}]}]},{"title":"Week 28 (n=42)","categories":[{"measurements":[{"groupId":"OG000","value":"-6.1","spread":"5.67"}]}]},{"title":"Week 32 (n=41)","categories":[{"measurements":[{"groupId":"OG000","value":"-6.4","spread":"5.81"}]}]},{"title":"Week 36 (n=41)","categories":[{"measurements":[{"groupId":"OG000","value":"-6.5","spread":"5.85"}]}]},{"title":"Week 40 (n=40)","categories":[{"measurements":[{"groupId":"OG000","value":"-6.4","spread":"6.55"}]}]},{"title":"Week 44 (n=40)","categories":[{"measurements":[{"groupId":"OG000","value":"-7.1","spread":"5.98"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Each Post Baseline Time Point","description":"CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at observation minus mean score at baseline.","populationDescription":"Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44","groups":[{"id":"OG000","title":"Venlafaxine ER 75-225 mg/Day Flexible","description":"Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"}]}],"classes":[{"title":"Week 1 (n=50)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.1","spread":"0.46"}]}]},{"title":"Week 2 (n=50)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"0.63"}]}]},{"title":"Week 3 (n=50)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"0.87"}]}]},{"title":"Week 4 (n=50)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.81"}]}]},{"title":"Week 6 (n=47)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"0.77"}]}]},{"title":"Week 8 (n=48)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"0.91"}]}]},{"title":"Week 12 (n=47)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.8","spread":"1.20"}]}]},{"title":"Week 16 (n=46)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"1.34"}]}]},{"title":"Week 20 (n=45)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"0.98"}]}]},{"title":"Week 24 (n=44)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"1.01"}]}]},{"title":"Week 28 (n=42)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"1.07"}]}]},{"title":"Week 32 (n=41)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"1.11"}]}]},{"title":"Week 36 (n=41)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"1.19"}]}]},{"title":"Week 40 (n=40)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"1.23"}]}]},{"title":"Week 44 (n=40)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"1.12"}]}]}]},{"type":"SECONDARY","title":"Mean Clinical Global Impression - Improvement (CGI-I) Score at Each Post Baseline Time Point","description":"CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 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. Scores above 4 reflect worsening of illness state as compared to baseline.","populationDescription":"Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44","groups":[{"id":"OG000","title":"Venlafaxine ER 75-225 mg/Day Flexible","description":"Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"}]}],"classes":[{"title":"Week 1 (n=50)","categories":[{"measurements":[{"groupId":"OG000","value":"3.8","spread":"0.62"}]}]},{"title":"Week 2 (n=50)","categories":[{"measurements":[{"groupId":"OG000","value":"3.5","spread":"0.81"}]}]},{"title":"Week 3 (n=50)","categories":[{"measurements":[{"groupId":"OG000","value":"3.3","spread":"1.05"}]}]},{"title":"Week 4 (n=50)","categories":[{"measurements":[{"groupId":"OG000","value":"3.1","spread":"1.05"}]}]},{"title":"Week 6 (n=47)","categories":[{"measurements":[{"groupId":"OG000","value":"2.9","spread":"0.91"}]}]},{"title":"Week 8 (n=48)","categories":[{"measurements":[{"groupId":"OG000","value":"2.9","spread":"0.96"}]}]},{"title":"Week 12 (n=47)","categories":[{"measurements":[{"groupId":"OG000","value":"2.6","spread":"1.06"}]}]},{"title":"Week 16 (n=46)","categories":[{"measurements":[{"groupId":"OG000","value":"2.4","spread":"1.20"}]}]},{"title":"Week 20 (n=45)","categories":[{"measurements":[{"groupId":"OG000","value":"2.1","spread":"0.97"}]}]},{"title":"Week 24 (n=44)","categories":[{"measurements":[{"groupId":"OG000","value":"2.2","spread":"1.05"}]}]},{"title":"Week 28 (n=42)","categories":[{"measurements":[{"groupId":"OG000","value":"2.2","spread":"1.09"}]}]},{"title":"Week 32 (n=41)","categories":[{"measurements":[{"groupId":"OG000","value":"2.1","spread":"1.14"}]}]},{"title":"Week 36 (n=41)","categories":[{"measurements":[{"groupId":"OG000","value":"2.2","spread":"1.18"}]}]},{"title":"Week 40 (n=40)","categories":[{"measurements":[{"groupId":"OG000","value":"2.1","spread":"1.25"}]}]},{"title":"Week 44 (n=40)","categories":[{"measurements":[{"groupId":"OG000","value":"2.0","spread":"1.15"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) at Each Post Baseline Time Point","description":"QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3, and the total score ranges from 0 to 27. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline.","populationDescription":"Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score and QIDS16-SR-J score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 12, 24, 44","groups":[{"id":"OG000","title":"Venlafaxine ER 75-225 mg/Day Flexible","description":"Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"49"}]}],"classes":[{"title":"Week 12 (n=47)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.7","spread":"4.97"}]}]},{"title":"Week 24 (n=44)","categories":[{"measurements":[{"groupId":"OG000","value":"-3.8","spread":"4.45"}]}]},{"title":"Week 44 (n=40)","categories":[{"measurements":[{"groupId":"OG000","value":"-4.7","spread":"4.73"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"Venlafaxine ER 75-225 mg/Day Flexible","description":"Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.","seriousNumAffected":2,"seriousNumAtRisk":50,"otherNumAffected":49,"otherNumAtRisk":50}],"seriousEvents":[{"term":"Pyrexia","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}]},{"term":"Crime","organSystem":"Social circumstances","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}]}],"otherEvents":[{"term":"Palpitations","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":50}]},{"term":"Hyperacusis","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}]},{"term":"Meniere's disease","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}]},{"term":"Tinnitus","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":50}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":50}]},{"term":"Blepharospasm","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}]},{"term":"Cataract","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}]},{"term":"Eye pruritus","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}]},{"term":"Ocular hyperaemia","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}]},{"term":"Abdominal discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":50}]},{"term":"Constipation","organSystem":"Gastrointestinal 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disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}]},{"term":"Chest discomfort","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":50}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":50}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}]},{"term":"Feeling abnormal","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":50}]},{"term":"Irritability","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":50}]},{"term":"Malaise","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":50}]},{"term":"Non-cardiac chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}]},{"term":"Thirst","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":50}]},{"term":"Hepatic function abnormal","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":50}]},{"term":"Seasonal allergy","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":50}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}]},{"term":"Cystitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}]},{"term":"Epiglottitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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