{"protocolSection":{"identificationModule":{"nctId":"NCT01101841","orgStudyIdInfo":{"id":"N30-004"},"organization":{"fullName":"Noven Therapeutics","class":"INDUSTRY"},"briefTitle":"24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms","officialTitle":"A Phase 3, Twenty-Four Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Mesafem (Paroxetine Mesylate) Capsules in the Treatment of Vasomotor Symptoms Associated With Menopause"},"statusModule":{"statusVerifiedDate":"2015-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-03"},"primaryCompletionDateStruct":{"date":"2011-09","type":"ACTUAL"},"completionDateStruct":{"date":"2011-11","type":"ACTUAL"},"studyFirstSubmitDate":"2010-04-08","studyFirstSubmitQcDate":"2010-04-09","studyFirstPostDateStruct":{"date":"2010-04-12","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-07-16","resultsFirstSubmitQcDate":"2014-03-20","resultsFirstPostDateStruct":{"date":"2014-04-21","type":"ESTIMATED"},"dispFirstSubmitDate":"2012-02-23","dispFirstSubmitQcDate":"2012-02-23","dispFirstPostDateStruct":{"date":"2012-02-24","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-10-14","lastUpdatePostDateStruct":{"date":"2015-10-15","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Noven Therapeutics","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause","detailedDescription":"The study is a 24-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg in subjects with moderate to severe postmenopausal VMS, defined as follows:\n\n1. Moderate VMS: Sensation of heat with sweating, able to continue activity\n2. Severe VMS: Sensation of heat with sweating, causing cessation of activity\n\nThe study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period."},"conditionsModule":{"conditions":["Hot Flashes"],"keywords":["Vasomotor Symptoms","Menopause","Hot Flashes","Perimenopause","Nonhormonal therapies","Climacteric symptoms","Mesafem","Low-Dose Mesylate salt of Paroxetine (LDMP)"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":570,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Brisdelle (paroxetine mesylate)","type":"EXPERIMENTAL","description":"Brisdelle (paroxetine mesylate)","interventionNames":["Drug: Brisdelle (paroxetine mesylate)"]},{"label":"Placebo capsules","type":"PLACEBO_COMPARATOR","description":"Sugar pill","interventionNames":["Drug: Placebo capsules"]}],"interventions":[{"type":"DRUG","name":"Brisdelle (paroxetine mesylate)","description":"Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.","armGroupLabels":["Brisdelle (paroxetine mesylate)"],"otherNames":["Former Names: Mesafem Capsules or","LDMP (Low-Dose Mesylate salt of Paroxetine)"]},{"type":"DRUG","name":"Placebo capsules","description":"Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.","armGroupLabels":["Placebo capsules"],"otherNames":["Sugar pill"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12.","description":"Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week.\n\nThe results reported are:\n\n* Mean Baseline frequency of moderate to severe VMS\n* Mean change in frequency of moderate to severe VMS from baseline to Week 4\n* Mean change in frequency of moderate to severe VMS from baseline to Week 12","timeFrame":"Week 4 and Week 12"},{"measure":"Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12.","description":"Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.\n\nWeekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes","timeFrame":"Week 4 and Week 12"}],"secondaryOutcomes":[{"measure":"Percent Persistence of Benefit, Statistically Significant Difference in Having 50% or More Reduction Compared to Baseline at Week 24.","description":"Persistence of treatment benefit to 24 weeks post treatment was assessed by using the following responder analysis. Responders were defined as those subjects who achieved ≥ 50% reduction from baseline in moderate to severe hot-flash frequency at Week 24; the percent change in hot flash frequency is calculated using the formula:\n\nPercent reduction at week 24 = \\[(number of moderate to severe hot flash frequency at baseline - number of moderate to severe hot flash frequency at week 24) / number of moderate to severe hot flash frequency at baseline \\]\\*100%.","timeFrame":"Week 24"},{"measure":"Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median","description":"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.\n\nFor the BMI \\<32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12.","timeFrame":"Week 4 and Week 12"},{"measure":"Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median","description":"Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes.\n\nThe diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline.","timeFrame":"Week 4 and Week 12"},{"measure":"Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median","description":"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.\n\nFor the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12.","timeFrame":"Week 4 and Week 12"},{"measure":"Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median","description":"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.\n\nFor the BMI \\<32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.\n\nSubjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.\n\nWeekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below.","timeFrame":"Week 4 and Week 12"},{"measure":"Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median","description":"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.\n\nFor the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.\n\nSubjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.\n\nWeekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below.","timeFrame":"Week 4 and Week 12"},{"measure":"Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median","description":"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.\n\nThe severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.\n\nThe total GCS score ranges from \"0\" to \"63\" which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject's total GCS score at baseline and at Week 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below.","timeFrame":"Week 4 and Week 12"},{"measure":"Percentage of Responders","description":"Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below.","timeFrame":"Week 4 and Week 12"},{"measure":"Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)","description":"Subject's overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered).\n\nResponders: Subjects with NRS Score of 5 Or Less. Non-Responders: Subjects With NRS Score of Greater than Or Equal to 6.","timeFrame":"Week 4 and Week 12"},{"measure":"Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score, Median","description":"The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.The sum of the scores for all 5 items was calculated at Week 4 and Week 12.","timeFrame":"Week 4 and Week 12"},{"measure":"Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS)","description":"Interference of hot flashes was measured by using the hot flash-related daily interference scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.\n\nThe measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question.","timeFrame":"Week 4 and Week 12"},{"measure":"Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.","description":"Proportion of NRS Responders: Subject's overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS)\n\nThe Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.\n\nResponders: Subjects Achieving a Score of \"Very Much Improved\" Or \"Much Improved\" Or \"Minimally Improved\".\n\nNon Responders: Subjects with a Score of \"No Change\" Or \"Minimally Worse\" Or \"Much Worse\" Or \"Very Much Worse\".","timeFrame":"Week 4 and Week 12"},{"measure":"Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression","description":"Depression \\& anxiety were measured by using the Hospital Anxiety \\& Depression Scale (HADS).\n\nThe HADS was developed to assess anxiety \\& depression. It is meant to differentiate symptoms of depression with those of anxiety.\n\nNumber of items: 14 (7 questions relating to anxiety; 7 questions relating to depression).\n\nResponses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed).\n\nResponses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale.\n\nThe results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety \\& Abnormal Depression at Week 4 and Week 12.","timeFrame":"Week 4 and Week 12"},{"measure":"Assessment of Mood","description":"Mood was measured by using the Profile of Mood States (POMS) questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from \"65\" to \"325.\" Each subject's total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below.","timeFrame":"Week 4 and Week 12"},{"measure":"BMI Change From Baseline (kg/m2), Median","description":"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.\n\nAssessment of the effect of Brisdelle compared with placebo on body mass index.","timeFrame":"Week 4 and Week 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Female, \\>40 years of age\n2. Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior\n3. Spontaneous amenorrhea for at least 12 consecutive months\n4. Amenorrhea for at least 6 months and meet the biochemical criteria for menopause\n5. Bilateral salpingo-oophorectomy \\>6 weeks with or without hysterectomy\n\nExclusion Criteria:\n\n1. BMI ≥ 40 kg/m²\n2. Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS\n3. History of self-injurious behavior\n4. History of clinical diagnosis of depression; or treatment for depression\n5. History of clinical diagnosis of borderline personality disorder\n6. Use of an investigational study medication within 30 days prior to screening or during the study\n7. Concurrent participation in another clinical trial or previous participation in this trial\n8. Family of investigational-site staff","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"40 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Derrick R Havin, MD","affiliation":"North Spokane Women's Clinic Research, Spokane, WA 99207","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Richard E Hedrick, MD","affiliation":"Hawthorne Medical Research, Inc., Winston-Salem, NC 27103","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Samuel N Lederman, MD","affiliation":"Altus Research, Lake Worth, FL 33461","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Larry S Seidman, DO","affiliation":"Philadelphia Clinical Research, LLC, Philadelphia, PA 19114","role":"PRINCIPAL_INVESTIGATOR"},{"name":"James E Tomblin, MD","affiliation":"Hawthorne Medical Research, Inc., Greensboro, NC 27408","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Peter A Zedler, MD","affiliation":"Virginia Women's Center, Richmond, VA 23233","role":"PRINCIPAL_INVESTIGATOR"},{"name":"D S Harnsberger, MD","affiliation":"Chattanooga Medical Research, LLC, Chattanooga, TN 37404","role":"PRINCIPAL_INVESTIGATOR"},{"name":"John A Hoekstra, MD","affiliation":"National Clinical Research, Inc., Richmond, VA 23294","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Robin Kroll, MD","affiliation":"Women's Clinical Research Center, Seattle, WA 98105","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Ashley Tunkle, MD","affiliation":"Anchor Research Center, Naples, FL 34102","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Matthew Davis, MD","affiliation":"Rochester Clinical Research, Rochester, NY 14609","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Donna DeSantis, MD","affiliation":"East Valley Family Physicians PLC, Chandler, AZ 85224","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Steven Drosman","affiliation":"Genesis Center For Clinical Research, San Diego, CA 92103","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Mildred Farmer, MD","affiliation":"Meridien Research, Brooksville, FL 34601","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Sandra Hurtado, MD","affiliation":"The Woman's Hospital of Texas Clinical Research Center, Houston, TX 77054","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Bruce Levine, MD","affiliation":"Phoenix Ob-Gyn Associates, LLC, Moorestown, NJ 08057","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Tyrone Malloy, MD","affiliation":"Soapstone Center for Clinical Research, Decatur, GA 30034","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Eric Ross, MD","affiliation":"Apex Research Institute, Santa Ana, CA 92705","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Cynthia Strout, MD","affiliation":"Coastal Carolina Research Center, Mt. Pleasant, SC 29464","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Arthur Waldbaum, MD","affiliation":"Downtown Women's Health Care, Denver, CO, 80218","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Edward Zbella, MD","affiliation":"Women's Medical Research Group, LLC, Clearwater, FL 33759","role":"PRINCIPAL_INVESTIGATOR"},{"name":"James R Dockery, MD","affiliation":"Montgomery Women's Health Associates, PC, Montgomery, AL 36116","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Stephen C Blank, MD","affiliation":"Mount Vernon Clinical Research, LLC, Sandy Springs, GA 30328","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Keith Aqua, MD","affiliation":"Visions Clinical Research, Boynton Beach, FL 33472","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Saul R Berg, MD","affiliation":"Clinical Trials Research Services, LLC, Pittsburgh, PA 15206","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Marvin Kalafer, MD","affiliation":"The Clinical Trial Center, LLC, Jenkintown, PA 19046","role":"PRINCIPAL_INVESTIGATOR"},{"name":"David J Portman, MD","affiliation":"Columbus Center for Women's Health Research, Columbus, Ohio 43213","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Stephen Swanson, MD","affiliation":"Women's Clinic of Lincoln, PC, Lincoln, NE 68510","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Joseph Soufer, MD","affiliation":"Chase Medical Research, LLC, Waterbury, CT 06708","role":"PRINCIPAL_INVESTIGATOR"},{"name":"ShaH R Scott, MD","affiliation":"Clinical Research Associates, Inc., Nashville, TN 37203","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Mary K Neuffer, MD","affiliation":"SC Clinical Research Center, LLC, Columbia, SC 29201","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Ronald Ackerman, MD","affiliation":"Comprehensive Clinical Trials, LLC, West Palm Beach, FL 33409","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Montgomery Women's Health Associates, PC","city":"Montgomery","state":"Alabama","zip":"36116","country":"United 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Beach","state":"Florida","zip":"33472","country":"United States","geoPoint":{"lat":26.52535,"lon":-80.06643}},{"facility":"Meridien Research","city":"Brooksville","state":"Florida","zip":"34601","country":"United States","geoPoint":{"lat":28.55554,"lon":-82.38991}},{"facility":"Women's Medical Research Group, LLC","city":"Clearwater","state":"Florida","zip":"33759","country":"United States","geoPoint":{"lat":27.96585,"lon":-82.8001}},{"facility":"Altus Research","city":"Lake Worth","state":"Florida","zip":"33461","country":"United States","geoPoint":{"lat":26.61708,"lon":-80.07231}},{"facility":"Anchor Research Center","city":"Naples","state":"Florida","zip":"34102","country":"United States","geoPoint":{"lat":26.14234,"lon":-81.79596}},{"facility":"Comprehensive Clinical Trials, LLC","city":"West Palm Beach","state":"Florida","zip":"33409","country":"United States","geoPoint":{"lat":26.71534,"lon":-80.05337}},{"facility":"Soapstone Center for Clinical 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Research, Inc.","city":"Winston-Salem","state":"North Carolina","zip":"27103","country":"United States","geoPoint":{"lat":36.09986,"lon":-80.24422}},{"facility":"Columbus Center for Women's Health Research","city":"Columbus","state":"Ohio","zip":"43213","country":"United States","geoPoint":{"lat":39.96118,"lon":-82.99879}},{"facility":"The Clinical Trial Center, LLC","city":"Jenkintown","state":"Pennsylvania","zip":"19046","country":"United States","geoPoint":{"lat":40.09594,"lon":-75.12517}},{"facility":"Philadelphia Clinical Research","city":"Philadelphia","state":"Pennsylvania","zip":"19114","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}},{"facility":"Clinical Trials Research Services, LLC","city":"Pittsburgh","state":"Pennsylvania","zip":"15206","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}},{"facility":"SC Clinical Research Center, LLC","city":"Columbia","state":"South Carolina","zip":"29201","country":"United 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Pleasant","state":"South Carolina","zip":"29464","country":"United States","geoPoint":{"lat":32.79407,"lon":-79.86259}},{"facility":"Chattanooga Medical Research, LLC","city":"Chattanooga","state":"Tennessee","zip":"37404","country":"United States","geoPoint":{"lat":35.04563,"lon":-85.30968}},{"facility":"Clinical Research Associates, Inc.","city":"Nashville","state":"Tennessee","zip":"37203","country":"United States","geoPoint":{"lat":36.16589,"lon":-86.78444}},{"facility":"The Woman's Hospital of Texas Clinical Research Center","city":"Houston","state":"Texas","zip":"77054","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Virginia Women's Center","city":"Richmond","state":"Virginia","zip":"23233","country":"United States","geoPoint":{"lat":37.55376,"lon":-77.46026}},{"facility":"National Clinical Research, Inc.","city":"Richmond","state":"Virginia","zip":"23294","country":"United States","geoPoint":{"lat":37.55376,"lon":-77.46026}},{"facility":"Women's Clinical Research Center","city":"Seattle","state":"Washington","zip":"98105","country":"United States","geoPoint":{"lat":47.60621,"lon":-122.33207}},{"facility":"North Spokane Women's Clinic Research","city":"Spokane","state":"Washington","zip":"99207","country":"United States","geoPoint":{"lat":47.65966,"lon":-117.42908}}]},"referencesModule":{"references":[{"pmid":"15292498","type":"BACKGROUND","citation":"Fugate SE, Church CO. Nonestrogen treatment modalities for vasomotor symptoms associated with menopause. Ann Pharmacother. 2004 Sep;38(9):1482-99. doi: 10.1345/aph.1D610. Epub 2004 Aug 3."},{"pmid":"11025867","type":"BACKGROUND","citation":"Kritz-Silverstein D, Goldani Von Muhlen D, Barrett-Connor E. Prevalence and clustering of menopausal symptoms in older women by hysterectomy and oophorectomy status. J Womens Health Gend Based Med. 2000 Sep;9(7):747-55. doi: 10.1089/15246090050147727."},{"pmid":"16670414","type":"BACKGROUND","citation":"Nelson HD, Vesco KK, Haney E, Fu R, Nedrow A, Miller J, Nicolaidis C, Walker M, Humphrey L. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA. 2006 May 3;295(17):2057-71. doi: 10.1001/jama.295.17.2057."},{"pmid":"1003364","type":"BACKGROUND","citation":"Greene JG. A factor analytic study of climacteric symptoms. J Psychosom Res. 1976;20(5):425-30. doi: 10.1016/0022-3999(76)90005-2. No abstract available."},{"pmid":"25137243","type":"DERIVED","citation":"Pinkerton JV, Joffe H, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Low-dose paroxetine (7.5 mg) improves sleep in women with vasomotor symptoms associated with menopause. Menopause. 2015 Jan;22(1):50-8. doi: 10.1097/GME.0000000000000311."},{"pmid":"24552977","type":"DERIVED","citation":"Portman DJ, Kaunitz AM, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause. Menopause. 2014 Oct;21(10):1082-90. doi: 10.1097/GME.0000000000000210."},{"pmid":"24045678","type":"DERIVED","citation":"Simon JA, Portman DJ, Kaunitz AM, Mekonnen H, Kazempour K, Bhaskar S, Lippman J. Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: two randomized controlled trials. Menopause. 2013 Oct;20(10):1027-35. doi: 10.1097/GME.0b013e3182a66aa7."}],"seeAlsoLinks":[{"label":"Sponsor","url":"http://www.noven.com"}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"24-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules in subjects with moderate to severe postmenopausal vasomotor symptoms.\n\nLocations: Medical Clinics","groups":[{"id":"FG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Experimental\n\nEligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"FG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"285"},{"groupId":"FG001","numSubjects":"285"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"235"},{"groupId":"FG001","numSubjects":"218"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"67"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"40"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Suicidality Tracking Scale","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Eligibility Criteria","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Experimental\n\nEligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"BG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"285"},{"groupId":"BG001","value":"285"},{"groupId":"BG002","value":"570"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"267"},{"groupId":"BG002","value":"536"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"34"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54.2","spread":"5.47"},{"groupId":"BG001","value":"54.5","spread":"5.74"},{"groupId":"BG002","value":"54.4","spread":"5.60"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"285"},{"groupId":"BG001","value":"285"},{"groupId":"BG002","value":"570"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"285"},{"groupId":"BG001","value":"285"},{"groupId":"BG002","value":"570"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12.","description":"Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week.\n\nThe results reported are:\n\n* Mean Baseline frequency of moderate to severe VMS\n* Mean change in frequency of moderate to severe VMS from baseline to Week 4\n* Mean change in frequency of moderate to severe VMS from baseline to Week 12","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Hot flashes per day","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"284"},{"groupId":"OG001","value":"284"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"10.83","spread":"3.86"},{"groupId":"OG001","value":"10.90","spread":"3.96"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-4.13","spread":"4.02"},{"groupId":"OG001","value":"-2.71","spread":"4.31"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-5.31","spread":"4.67"},{"groupId":"OG001","value":"-3.94","spread":"5.13"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Week 4 frequency","statisticalMethod":"Rank transformed ANCOVA"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0001","pValueComment":"Week 12 frequency","statisticalMethod":"Rank transformed ANCOVA"}]},{"type":"SECONDARY","title":"Percent Persistence of Benefit, Statistically Significant Difference in Having 50% or More Reduction Compared to Baseline at Week 24.","description":"Persistence of treatment benefit to 24 weeks post treatment was assessed by using the following responder analysis. Responders were defined as those subjects who achieved ≥ 50% reduction from baseline in moderate to severe hot-flash frequency at Week 24; the percent change in hot flash frequency is calculated using the formula:\n\nPercent reduction at week 24 = \\[(number of moderate to severe hot flash frequency at baseline - number of moderate to severe hot flash frequency at week 24) / number of moderate to severe hot flash frequency at baseline \\]\\*100%.","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of total number of subjects","timeFrame":"Week 24","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"284"},{"groupId":"OG001","value":"284"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"47.54"},{"groupId":"OG001","value":"36.27"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0066","pValueComment":"Week 24 persistence of effect","statisticalMethod":"Logit model"}]},{"type":"SECONDARY","title":"Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median","description":"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.\n\nFor the BMI \\<32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12.","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"Hot flashes per week","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"197"},{"groupId":"OG001","value":"179"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-28.50","lowerLimit":"-130","upperLimit":"48.00"},{"groupId":"OG001","value":"-18.0","lowerLimit":"-151","upperLimit":"119.0"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-41.00","lowerLimit":"-150","upperLimit":"119.0"},{"groupId":"OG001","value":"-27.00","lowerLimit":"-168","upperLimit":"127.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median","description":"Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes.\n\nThe diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline.","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"Awakenings","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"255"},{"groupId":"OG001","value":"241"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-8.50","lowerLimit":"-78.1","upperLimit":"46.00"},{"groupId":"OG001","value":"-6.62","lowerLimit":"-47.0","upperLimit":"34.00"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-13.15","lowerLimit":"-80.1","upperLimit":"49.00"},{"groupId":"OG001","value":"-8.67","lowerLimit":"-47.5","upperLimit":"22.67"}]}]}]},{"type":"SECONDARY","title":"Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median","description":"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.\n\nFor the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12.","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"Hot flashes per week","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either MesaBrisdelle (paroxetine mesylate) Capsules fem or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"65"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-22.0","lowerLimit":"-118","upperLimit":"30.00"},{"groupId":"OG001","value":"-17.0","lowerLimit":"-93","upperLimit":"140.0"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-31.50","lowerLimit":"-124","upperLimit":"38.00"},{"groupId":"OG001","value":"-23.00","lowerLimit":"-93","upperLimit":"57.00"}]}]}]},{"type":"SECONDARY","title":"Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median","description":"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.\n\nFor the BMI \\<32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.\n\nSubjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.\n\nWeekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below.","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"Hot Flash Severity scores per week","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"187"},{"groupId":"OG001","value":"173"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-0.033","lowerLimit":"-1.0","upperLimit":"0.50"},{"groupId":"OG001","value":"-0.004","lowerLimit":"-1.0","upperLimit":"0.70"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-0.045","lowerLimit":"-1.0","upperLimit":"0.89"},{"groupId":"OG001","value":"-0.00","lowerLimit":"-1.0","upperLimit":"0.74"}]}]}]},{"type":"SECONDARY","title":"Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median","description":"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.\n\nFor the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.\n\nSubjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.\n\nWeekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below.","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"Hot Flash Severity scores per week","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"63"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-0.039","lowerLimit":"-0.94","upperLimit":"0.81"},{"groupId":"OG001","value":"-0.036","lowerLimit":"-0.56","upperLimit":"0.71"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-0.052","lowerLimit":"-0.57","upperLimit":"0.97"},{"groupId":"OG001","value":"-0.051","lowerLimit":"-1.0","upperLimit":"0.71"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median","description":"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.\n\nThe severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.\n\nThe total GCS score ranges from \"0\" to \"63\" which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject's total GCS score at baseline and at Week 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below.","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"units on a scale","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"216"},{"groupId":"OG001","value":"203"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-3.00","lowerLimit":"-36","upperLimit":"16.00"},{"groupId":"OG001","value":"-3.00","lowerLimit":"-37","upperLimit":"13.00"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-4.00","lowerLimit":"-33","upperLimit":"14.00"},{"groupId":"OG001","value":"-3.00","lowerLimit":"-32","upperLimit":"48.00"}]}]}]},{"type":"SECONDARY","title":"Percentage of Responders","description":"Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below.","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"284"},{"groupId":"OG001","value":"284"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"35.56"},{"groupId":"OG001","value":"25.35"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"49.30"},{"groupId":"OG001","value":"33.80"}]}]}]},{"type":"SECONDARY","title":"Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)","description":"Subject's overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered).\n\nResponders: Subjects with NRS Score of 5 Or Less. Non-Responders: Subjects With NRS Score of Greater than Or Equal to 6.","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of total number of subjects","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"281"},{"groupId":"OG001","value":"281"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"35.48"},{"groupId":"OG001","value":"25.27"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"46.62"},{"groupId":"OG001","value":"37.72"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score, Median","description":"The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.The sum of the scores for all 5 items was calculated at Week 4 and Week 12.","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"Units on a scale","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"202"},{"groupId":"OG001","value":"216"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","lowerLimit":"-3.00","upperLimit":"4.00"},{"groupId":"OG001","value":"0.00","lowerLimit":"-3.00","upperLimit":"4.00"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","lowerLimit":"-3.00","upperLimit":"4.00"},{"groupId":"OG001","value":"0.00","lowerLimit":"-3.00","upperLimit":"3.00"}]}]}]},{"type":"SECONDARY","title":"Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS)","description":"Interference of hot flashes was measured by using the hot flash-related daily interference scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.\n\nThe measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question.","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percent of participants","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"214"},{"groupId":"OG001","value":"197"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"26.03"},{"groupId":"OG001","value":"30.51"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"15.89"},{"groupId":"OG001","value":"21.32"}]}]}]},{"type":"SECONDARY","title":"Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.","description":"Proportion of NRS Responders: Subject's overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS)\n\nThe Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.\n\nResponders: Subjects Achieving a Score of \"Very Much Improved\" Or \"Much Improved\" Or \"Minimally Improved\".\n\nNon Responders: Subjects with a Score of \"No Change\" Or \"Minimally Worse\" Or \"Much Worse\" Or \"Very Much Worse\".","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"249"},{"groupId":"OG001","value":"231"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"67.88"},{"groupId":"OG001","value":"53.58"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"69.88"},{"groupId":"OG001","value":"59.74"}]}]}]},{"type":"SECONDARY","title":"Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression","description":"Depression \\& anxiety were measured by using the Hospital Anxiety \\& Depression Scale (HADS).\n\nThe HADS was developed to assess anxiety \\& depression. It is meant to differentiate symptoms of depression with those of anxiety.\n\nNumber of items: 14 (7 questions relating to anxiety; 7 questions relating to depression).\n\nResponses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed).\n\nResponses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale.\n\nThe results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety \\& Abnormal Depression at Week 4 and Week 12.","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"218"},{"groupId":"OG001","value":"210"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"5.65"},{"groupId":"OG001","value":"2.44"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"4.13"},{"groupId":"OG001","value":"5.24"}]}]}]},{"type":"SECONDARY","title":"Assessment of Mood","description":"Mood was measured by using the Profile of Mood States (POMS) questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from \"65\" to \"325.\" Each subject's total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below.","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percent of participants","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"218"},{"groupId":"OG001","value":"208"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"37.40"},{"groupId":"OG001","value":"42.39"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"37.16"},{"groupId":"OG001","value":"44.23"}]}]}]},{"type":"SECONDARY","title":"BMI Change From Baseline (kg/m2), Median","description":"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.\n\nAssessment of the effect of Brisdelle compared with placebo on body mass index.","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"kg/m2","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"250"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","lowerLimit":"-2.17","upperLimit":"2.66"},{"groupId":"OG001","value":"0.08","lowerLimit":"-3.08","upperLimit":"9.15"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"0.15","lowerLimit":"-2.33","upperLimit":"2.10"},{"groupId":"OG001","value":"0.11","lowerLimit":"-2.56","upperLimit":"9.70"}]}]}]},{"type":"PRIMARY","title":"Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12.","description":"Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.\n\nWeekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes","populationDescription":"The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Hot Flash Severity Score per day","timeFrame":"Week 4 and Week 12","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."},{"id":"OG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"284"},{"groupId":"OG001","value":"284"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"2.525","spread":"0.30"},{"groupId":"OG001","value":"2.532","spread":"0.32"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-0.092","spread":"0.24"},{"groupId":"OG001","value":"-0.059","spread":"0.22"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-0.0126","spread":"0.31"},{"groupId":"OG001","value":"-0.066","spread":"0.26"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0368","pValueComment":"Week 4 severity","statisticalMethod":"Rank transformed ANCOVA"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0064","pValueComment":"Week 12 severity","statisticalMethod":"Rank transformed ANCOVA"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"24 Weeks","eventGroups":[{"id":"EG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Experimental\n\nEligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.","seriousNumAffected":13,"seriousNumAtRisk":285,"otherNumAffected":161,"otherNumAtRisk":285},{"id":"EG001","title":"Placebo Capsules","description":"Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.","seriousNumAffected":7,"seriousNumAtRisk":285,"otherNumAffected":146,"otherNumAtRisk":285}],"seriousEvents":[{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Dysphagia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Gastrointestinal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Biliary dyskinesia","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Cholecystitis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Acetabulum fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Femur fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Arthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":285},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":285}]},{"term":"Endometrial cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Squamous cell carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Suicidal ideation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Suicide attempt","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Asthma","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]}],"otherEvents":[{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Lymphadenitis","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Arrhythmia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Bradycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Palpitations","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Ventricular dysfunction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Dermoid cyst","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Tinnitus","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Hypothyroidism","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Conjunctivitis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Eye allergy","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Eye irritation","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Eye pain","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Photophobia","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Retinal degeneration","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Ulcerative keratitis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Vision blurred","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":285}]},{"term":"Vitreous haemorrhage","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Abdominal discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":285},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":285}]},{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":285},{"groupId":"EG001","numEvents":3,"numAffected":2,"numAtRisk":285}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Abdominal pain lower","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":285},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":285}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":285},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":285}]},{"term":"Colonic polyp","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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