{"protocolSection":{"identificationModule":{"nctId":"NCT00401245","orgStudyIdInfo":{"id":"3151A2-405"},"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms","officialTitle":"The Effect of Dose Titration and Dose Tapering on the Tolerability of DVS SR in Women With Vasomotor Symptoms Associated With Menopause: The PRIMMUS (PRIstiq for Managing Menopause and Understanding Symptoms) Study"},"statusModule":{"statusVerifiedDate":"2011-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-12"},"primaryCompletionDateStruct":{"date":"2008-01","type":"ACTUAL"},"completionDateStruct":{"date":"2008-01","type":"ACTUAL"},"studyFirstSubmitDate":"2006-11-17","studyFirstSubmitQcDate":"2006-11-17","studyFirstPostDateStruct":{"date":"2006-11-20","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-09-06","resultsFirstSubmitQcDate":"2011-09-06","resultsFirstPostDateStruct":{"date":"2011-10-12","type":"ESTIMATED"},"dispFirstSubmitDate":"2009-01-21","dispFirstSubmitQcDate":"2010-05-13","dispFirstPostDateStruct":{"date":"2010-05-14","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-10-24","lastUpdatePostDateStruct":{"date":"2011-10-26","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued."},"conditionsModule":{"conditions":["Vasomotor Symptoms"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":500,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"A","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: desvenlafaxine succinate sustained release"]},{"label":"B","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: desvenlafaxine succinate sustained release"]},{"label":"C","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: desvenlafaxine succinate sustained release"]},{"label":"D","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: desvenlafaxine succinate sustained release"]},{"label":"E","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Placebo"]},{"label":"F","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: desvenlafaxine succinate sustained release"]},{"label":"G","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: desvenlafaxine succinate sustained release"]},{"label":"H","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: desvenlafaxine succinate sustained release"]}],"interventions":[{"type":"DRUG","name":"desvenlafaxine succinate sustained release","description":"Titration 100 mg","armGroupLabels":["A"]},{"type":"DRUG","name":"desvenlafaxine succinate sustained release","description":"Titration 50 mg","armGroupLabels":["B"]},{"type":"DRUG","name":"desvenlafaxine succinate sustained release","description":"Titration 25 mg, 50mg","armGroupLabels":["C"]},{"type":"DRUG","name":"desvenlafaxine succinate sustained release","description":"Titration 25 mg","armGroupLabels":["D"]},{"type":"DRUG","name":"Placebo","description":"Tapering placebo","armGroupLabels":["E"]},{"type":"DRUG","name":"desvenlafaxine succinate sustained release","description":"Tapering 50 mg, placebo","armGroupLabels":["F"]},{"type":"DRUG","name":"desvenlafaxine succinate sustained release","description":"Tapering 50 mg, 25 mg","armGroupLabels":["G"]},{"type":"DRUG","name":"desvenlafaxine succinate sustained release","description":"Tapering 50 mg QOD","armGroupLabels":["H"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Nausea During the First 2 Weeks of Treatment","description":"Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted.","timeFrame":"Baseline up to Week 2"},{"measure":"Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering","description":"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of \"new symptoms\" and \"old (but worse) symptoms\" (1) and 0 for \"old and unchanged symptom\", \"absent\", or \"old symptom but improved\" for a total possible range of 0 to 43. A higher score indicates more symptoms.","timeFrame":"Week 17"},{"measure":"DESS Total Score at End of Second Week of Tapering","description":"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of \"new symptoms\" and \"old (but worse) symptoms\" (1) and 0 for \"old and unchanged symptom\", \"absent\", or \"old symptom but improved\" for a total possible range of 0 to 43. A higher score indicates more symptoms.","timeFrame":"Week 18"},{"measure":"DESS Total Score at 1 Week After the End of Tapering","description":"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of \"new symptoms\" and \"old (but worse) symptoms\" (1) and 0 for \"old and unchanged symptom\", \"absent\", or \"old symptom but improved\" for a total possible range of 0 to 43. A higher score indicates more symptoms.","timeFrame":"Week 19"}],"secondaryOutcomes":[{"measure":"Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment","description":"Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.","timeFrame":"Baseline up to Week 2"},{"measure":"Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment","description":"Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.","timeFrame":"Baseline up to Week 2"},{"measure":"Number of Participants With Each DESS at the End of First Week of Tapering","description":"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.","timeFrame":"Week 17"},{"measure":"Number of Participants With Each DESS at the End of Second Week of Tapering","description":"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.","timeFrame":"Week 18"},{"measure":"Number of Participants With Each DESS One Week After End of Tapering","description":"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.","timeFrame":"Week 19"},{"measure":"Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment","description":"Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an interactive voice response system (IVRS)/interactive web based response system (IWRS), and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.","timeFrame":"Week 1 and Week 2"},{"measure":"Number of Participants Showing Satisfaction With Tolerability at the End of Tapering","description":"Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an IVRS/IWRS and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.","timeFrame":"Week 19"},{"measure":"Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score","description":"MS-TSQ is a questionnaire assessing participants' degree of satisfaction with regard to the test article which was administered to the participants via an IVRS/IWRS. The questionnaire comprised 8 questions and each was rated on a scale from 0 (extremely dissatisfied) to 4 (extremely satisfied).","timeFrame":"Week 16"},{"measure":"Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16","description":"MenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life.","timeFrame":"Baseline, Week 4, Week 8, Week 12 and Week 16"}],"otherOutcomes":[{"measure":"Mean Age of the Participants in Tapering Phase","description":"Participants were re-randomized to tapering phase after OL phase.","timeFrame":"Week 17"},{"measure":"Gender of the Participants in Tapering Phase","description":"Participants were re-randomized to tapering phase after OL phase.","timeFrame":"Week 17"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Generally healthy, postmenopausal woman who seeks treatment for hot flushes.\n* Meets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \\> 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH levels \\>40 mIU/mL.\n\nExclusion Criteria:\n\n* History of a seizure disorder other than a single childhood febrile seizure.\n* History or presence of clinically important hepatic or renal disease or other medical disease.\n* Presence or recent history of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Pfizer Investigational Site","city":"Tucson","state":"Arizona","zip":"85710","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"facility":"Pfizer Investigational Site","city":"Tucson","state":"Arizona","zip":"85715","country":"United 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A second randomization occurred for the taper phase.","groups":[{"id":"FG000","title":"DVS 25 mg, Then 100 mg","description":"Desvenlafaxine succinate (DVS) 25 milligram (mg) tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week open label (OL) phase."},{"id":"FG001","title":"DVS 25/50 mg, Then 100 mg","description":"DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase."},{"id":"FG002","title":"DVS 50 mg, Then 100 mg","description":"DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase."},{"id":"FG003","title":"DVS 100 mg, Then 100 mg","description":"DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase."},{"id":"FG004","title":"DVS 50 mg QOD","description":"Re-randomized to DVS 50 mg tablet taken orally every other day (QOD) alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase)."},{"id":"FG005","title":"DVS 50/25 mg","description":"Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase)."},{"id":"FG006","title":"DVS 50 mg/Placebo","description":"Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase)."},{"id":"FG007","title":"Placebo","description":"Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase)."}],"periods":[{"title":"Double Blind Titration 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Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"126"},{"groupId":"BG001","value":"121"},{"groupId":"BG002","value":"124"},{"groupId":"BG003","value":"122"},{"groupId":"BG004","value":"493"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With Nausea During the First 2 Weeks of Treatment","description":"Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted.","populationDescription":"The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline up to Week 2","groups":[{"id":"OG000","title":"DVS 25 mg, Then 100 mg","description":"DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase."},{"id":"OG001","title":"DVS 25/50 mg, Then 100 mg","description":"DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase."},{"id":"OG002","title":"DVS 50 mg, Then 100 mg","description":"DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase."},{"id":"OG003","title":"DVS 100 mg, Then 100 mg","description":"DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"121"},{"groupId":"OG002","value":"124"},{"groupId":"OG003","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"28"},{"groupId":"OG003","value":"43"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003"],"groupDescription":"Overall comparison was made between each titration regimen and the control regimen (100 mg).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.024","pValueComment":"The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.","statisticalMethod":"Chi-squared"}]},{"type":"PRIMARY","title":"Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering","description":"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. 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For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase)."},{"id":"OG002","title":"DVS 50 mg/Placebo","description":"Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase)."},{"id":"OG003","title":"Placebo","description":"Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"86"},{"groupId":"OG002","value":"83"},{"groupId":"OG003","value":"98"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.26","spread":"3.46"},{"groupId":"OG001","value":"2.28","spread":"3.59"},{"groupId":"OG002","value":"1.84","spread":"3.36"},{"groupId":"OG003","value":"7.07","spread":"7.13"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"For DVS 50 mg QOD, analysis of variance (ANOVA) was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"< 0.001","pValueComment":"The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.","statisticalMethod":"ANOVA"},{"groupIds":["OG001","OG003"],"groupDescription":"For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.","statisticalMethod":"ANOVA"},{"groupIds":["OG002","OG003"],"groupDescription":"For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.","statisticalMethod":"ANOVA"}]},{"type":"PRIMARY","title":"DESS Total Score at End of Second Week of Tapering","description":"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. 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For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase)."},{"id":"OG002","title":"DVS 50 mg/Placebo","description":"Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase)."},{"id":"OG003","title":"Placebo","description":"Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"89"},{"groupId":"OG001","value":"87"},{"groupId":"OG002","value":"79"},{"groupId":"OG003","value":"91"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.19","spread":"1.96"},{"groupId":"OG001","value":"2.44","spread":"5.53"},{"groupId":"OG002","value":"4.46","spread":"6.44"},{"groupId":"OG003","value":"2.44","spread":"4.96"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.092","pValueComment":"The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.","statisticalMethod":"ANOVA"},{"groupIds":["OG001","OG003"],"groupDescription":"For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.997","pValueComment":"The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.","statisticalMethod":"ANOVA"},{"groupIds":["OG002","OG003"],"groupDescription":"For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.009","pValueComment":"The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.","statisticalMethod":"ANOVA"}]},{"type":"PRIMARY","title":"DESS Total Score at 1 Week After the End of Tapering","description":"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. 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Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"Week 19","groups":[{"id":"OG000","title":"DVS 50 mg QOD","description":"Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase)."},{"id":"OG001","title":"DVS 50/25 mg","description":"Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase)."},{"id":"OG002","title":"DVS 50 mg/Placebo","description":"Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. 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tearfulness","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"3"}]}]},{"title":"Burning, numbness, tingling sensations","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"}]}]},{"title":"Chills","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"3"}]}]},{"title":"Confusion or trouble concentrating","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"2"}]}]},{"title":"Diarrhea","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}]}]},{"title":"Dizziness, lightheadedness, sensation of spinning","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"}]}]},{"title":"Elevated mood, feeling high","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Fatigue, tiredness","categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"8"}]}]},{"title":"Feeling unreal or detached","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"3"}]}]},{"title":"Fever","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Forgetfulness or problems with memory","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"3"}]}]},{"title":"Headaches","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"5"}]}]},{"title":"Increased dreaming or nightmares","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"}]}]},{"title":"Increased saliva in mouth","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}]}]},{"title":"Irritability","categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"6"}]}]},{"title":"Mood swings","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"4"}]}]},{"title":"Muscle aches or pains","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"}]}]},{"title":"Muscle cramps, spasms, or twitching","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}]}]},{"title":"Muscle tension or stiffness","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"}]}]},{"title":"Nausea","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Nervousness or anxiety","categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"}]}]},{"title":"Nose running","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"1"}]}]},{"title":"Problems with speech or speaking clearly","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Restless feeling in legs","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"1"}]}]},{"title":"Ringing or noises in the ears","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Shaking, trembling","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Shortness of breath, gasping for air","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Sore eyes","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"}]}]},{"title":"Stomach bloating","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"4"}]}]},{"title":"Stomach cramps","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"}]}]},{"title":"Sudden outbursts of anger","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"5"}]}]},{"title":"Sudden panic or anxiety attacks","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"}]}]},{"title":"Sudden worsening of mood","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"5"}]}]},{"title":"Sweating more than usual","categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"12"}]}]},{"title":"Trouble sleeping, insomnia","categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"7"}]}]},{"title":"Uncontrolled mouth/tongue movements","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Unsteady gait or incoordination","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Unusual sensitivity to sound","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Unusual tastes or smells","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Unusual visual sensations","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Vomiting","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment","description":"Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an interactive voice response system (IVRS)/interactive web based response system (IWRS), and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.","populationDescription":"The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 1 and Week 2","groups":[{"id":"OG000","title":"DVS 25 mg, Then 100 mg","description":"DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase."},{"id":"OG001","title":"DVS 25/50 mg, Then 100 mg","description":"DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase."},{"id":"OG002","title":"DVS 50 mg, Then 100 mg","description":"DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase."},{"id":"OG003","title":"DVS 100 mg, Then 100 mg","description":"DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"121"},{"groupId":"OG002","value":"124"},{"groupId":"OG003","value":"122"}]}],"classes":[{"title":"Week 1: Extremely dissatisfied (n=124,119,120,111)","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"4"}]}]},{"title":"Week 1: Dissatisfied (n=124,119,120,111)","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"16"}]}]},{"title":"Week 1: Neutral (n=124,119,120,111)","categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"28"},{"groupId":"OG003","value":"19"}]}]},{"title":"Week 1: Satisfied (n=124,119,120,111)","categories":[{"measurements":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"48"},{"groupId":"OG002","value":"43"},{"groupId":"OG003","value":"39"}]}]},{"title":"Week 1: Extremely satisfied (n=124,119,120,111)","categories":[{"measurements":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"49"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"33"}]}]},{"title":"Week 2: Extremely dissatisfied (n=115,105,113,94)","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Week 2: Dissatisfied (n=115,105,113,94)","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"1"}]}]},{"title":"Week 2: Neutral (n=115,105,113,94)","categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"18"},{"groupId":"OG003","value":"15"}]}]},{"title":"Week 2: Satisfied (n=115,105,113,94)","categories":[{"measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"35"},{"groupId":"OG002","value":"41"},{"groupId":"OG003","value":"40"}]}]},{"title":"Week 2: Extremely satisfied (n=115,105,113,94)","categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"49"},{"groupId":"OG002","value":"46"},{"groupId":"OG003","value":"38"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Showing Satisfaction With Tolerability at the End of Tapering","description":"Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an IVRS/IWRS and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.","populationDescription":"Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 19","groups":[{"id":"OG000","title":"DVS 50 mg QOD","description":"Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase)."},{"id":"OG001","title":"DVS 50/25 mg","description":"Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase)."},{"id":"OG002","title":"DVS 50 mg/Placebo","description":"Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase)."},{"id":"OG003","title":"Placebo","description":"Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"52"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"55"}]}],"classes":[{"title":"Extremely dissatisfied","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"}]}]},{"title":"Dissatisfied","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"5"}]}]},{"title":"Neutral","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"7"}]}]},{"title":"Satisfied","categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"19"}]}]},{"title":"Extremely satisfied","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"18"}]}]}]},{"type":"SECONDARY","title":"Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score","description":"MS-TSQ is a questionnaire assessing participants' degree of satisfaction with regard to the test article which was administered to the participants via an IVRS/IWRS. The questionnaire comprised 8 questions and each was rated on a scale from 0 (extremely dissatisfied) to 4 (extremely satisfied).","populationDescription":"The OL population included all participants who had taken at least 1 dose of open label test article. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"Week 16","groups":[{"id":"OG000","title":"DVS 100 mg","description":"DVS 100 mg tablet taken orally daily for 15 weeks (OL phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"}]}],"classes":[{"title":"Ability to control hot flushes during the day","categories":[{"measurements":[{"groupId":"OG000","value":"2.64","spread":"1.19"}]}]},{"title":"Ability to control hot flushes during the night","categories":[{"measurements":[{"groupId":"OG000","value":"2.71","spread":"1.26"}]}]},{"title":"Effect on quality of sleep","categories":[{"measurements":[{"groupId":"OG000","value":"2.59","spread":"1.18"}]}]},{"title":"Effect on mood or emotions","categories":[{"measurements":[{"groupId":"OG000","value":"3.02","spread":"0.86"}]}]},{"title":"Effect on interest in sex","categories":[{"measurements":[{"groupId":"OG000","value":"2.37","spread":"1.00"}]}]},{"title":"Effect on ability to concentrate","categories":[{"measurements":[{"groupId":"OG000","value":"2.67","spread":"0.84"}]}]},{"title":"Tolerability to side effects","categories":[{"measurements":[{"groupId":"OG000","value":"3.04","spread":"0.94"}]}]},{"title":"Overall satisfaction","categories":[{"measurements":[{"groupId":"OG000","value":"2.81","spread":"1.10"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16","description":"MenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life.","populationDescription":"The OL population included all participants who had taken at least 1 dose of open label test article. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"Baseline, Week 4, Week 8, Week 12 and Week 16","groups":[{"id":"OG000","title":"DVS 100 mg","description":"DVS 100 mg tablet taken orally daily for 15 weeks (OL phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"406"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"4.46","spread":"1.20"}]}]},{"title":"Week 4 (n=385)","categories":[{"measurements":[{"groupId":"OG000","value":"2.99","spread":"1.09"}]}]},{"title":"Week 8 (n=364)","categories":[{"measurements":[{"groupId":"OG000","value":"2.85","spread":"1.08"}]}]},{"title":"Week 12 (n=354)","categories":[{"measurements":[{"groupId":"OG000","value":"2.76","spread":"1.06"}]}]},{"title":"Week 16 (n=277)","categories":[{"measurements":[{"groupId":"OG000","value":"2.67","spread":"1.17"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"Comparison was made between the difference in the means from the baseline value and post-baseline (Week 4) value with 0.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.","statisticalMethod":"t-test, 2 sided"},{"groupIds":["OG000"],"groupDescription":"Comparison was made between the difference in the means from the baseline value and post-baseline (Week 8) value with 0.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"< 0.001","pValueComment":"The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.","statisticalMethod":"t-test, 2 sided"},{"groupIds":["OG000"],"groupDescription":"Comparison was made between the difference in the means from the base value and post-baseline (Week 12) value with 0.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.","statisticalMethod":"t-test, 2 sided"},{"groupIds":["OG000"],"groupDescription":"Comparison was made between the difference in the means from the baseline value and post-baseline (Week 16) value with 0.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.","statisticalMethod":"t-test, 2 sided"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Mean Age of the Participants in Tapering Phase","description":"Participants were re-randomized to tapering phase after OL phase.","populationDescription":"The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Years","timeFrame":"Week 17","groups":[{"id":"OG000","title":"DVS 50 mg QOD","description":"Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase)."},{"id":"OG001","title":"DVS 50/25 mg","description":"Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase)."},{"id":"OG002","title":"DVS 50 mg/Placebo","description":"Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase)."},{"id":"OG003","title":"Placebo","description":"Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"94"},{"groupId":"OG002","value":"87"},{"groupId":"OG003","value":"102"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"53.72","spread":"5.02"},{"groupId":"OG001","value":"54.56","spread":"5.21"},{"groupId":"OG002","value":"54.20","spread":"6.31"},{"groupId":"OG003","value":"54.14","spread":"5.09"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Gender of the Participants in Tapering Phase","description":"Participants were re-randomized to tapering phase after OL phase.","populationDescription":"The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 17","groups":[{"id":"OG000","title":"DVS 50 mg QOD","description":"Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase)."},{"id":"OG001","title":"DVS 50/25 mg","description":"Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase)."},{"id":"OG002","title":"DVS 50 mg/Placebo","description":"Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase)."},{"id":"OG003","title":"Placebo","description":"Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"94"},{"groupId":"OG002","value":"87"},{"groupId":"OG003","value":"102"}]}],"classes":[{"title":"Female","categories":[{"measurements":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"94"},{"groupId":"OG002","value":"87"},{"groupId":"OG003","value":"102"}]}]},{"title":"Male","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"2","description":"The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.","eventGroups":[{"id":"EG000","title":"DVS 25 mg (Titration Phase)","description":"DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase).","seriousNumAffected":0,"seriousNumAtRisk":126,"otherNumAffected":50,"otherNumAtRisk":126},{"id":"EG001","title":"DVS 25/50 mg (Titration Phase)","description":"DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase).","seriousNumAffected":0,"seriousNumAtRisk":121,"otherNumAffected":55,"otherNumAtRisk":121},{"id":"EG002","title":"DVS 50 mg (Titration Phase)","description":"DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase).","seriousNumAffected":0,"seriousNumAtRisk":124,"otherNumAffected":57,"otherNumAtRisk":124},{"id":"EG003","title":"DVS 100 mg (Titration Phase)","description":"DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase).","seriousNumAffected":0,"seriousNumAtRisk":122,"otherNumAffected":73,"otherNumAtRisk":122},{"id":"EG004","title":"DVS 100 mg (OL Phase)","description":"After 1 week of double blind titration phase, DVS 100 mg tablet taken orally daily for 15 weeks.","seriousNumAffected":3,"seriousNumAtRisk":461,"otherNumAffected":340,"otherNumAtRisk":461},{"id":"EG005","title":"DVS 50 mg QOD (Tapering Phase)","description":"Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).","seriousNumAffected":0,"seriousNumAtRisk":101,"otherNumAffected":74,"otherNumAtRisk":101},{"id":"EG006","title":"DVS 50/25 mg (Tapering Phase)","description":"Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. 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