{ "FullStudy":{ "Rank":217783, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516892", "OrgStudyIdInfo":{ "OrgStudyId":"GMA-BTX-CM-10-001" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"The COMPEL Study", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Allergan, Inc" } ] }, "Organization":{ "OrgFullName":"Allergan", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine" }, "StatusModule":{ "StatusVerifiedDate":"November 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"November 2015", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 20, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"November 9, 2016", "ResultsFirstSubmitQCDate":"November 9, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"January 6, 2017", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 9, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 6, 2017", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Allergan", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This open-label study will assess the long-term efficacy, safety, and tolerability of onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic migraine." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Migraine Disorders" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"716", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"BOTOX®", "ArmGroupType":"Experimental", "ArmGroupDescription":"Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: onabotulinumtoxinA" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Biological", "InterventionName":"onabotulinumtoxinA", "InterventionDescription":"Participants received 155 U of onabotulinumtoxinA approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "BOTOX®" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "BOTOX®", "botulinum toxin Type A" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change From Baseline in the Frequency of Headache Days", "PrimaryOutcomeDescription":"Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 108. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.", "PrimaryOutcomeTimeFrame":"Baseline, Week 108" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change From Baseline in the Frequency of Headache Days", "SecondaryOutcomeDescription":"Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 60. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.", "SecondaryOutcomeTimeFrame":"Baseline, Week 60" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score", "SecondaryOutcomeDescription":"The HIT-6 measures the impact of headache and treatment on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 4-week period. The total possible score ranges from 36 (no impact) to 78 (worst impact). A negative change from Baseline indicates an improvement, and a positive change from Baseline indicates a worsening.", "SecondaryOutcomeTimeFrame":"Baseline, Week 60, Week 108" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)\n\nExclusion Criteria:\n\nDiagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or amyotrophic lateral sclerosis\nHeadache attributed to another disorder\nInfection or skin disorder at injection sites\nPrevious treatment with botulinum toxin of any serotype for any reason\nAnticipated need for botulinum toxin of any type for any reason during the course of the study\nPrevious participation in any botulinum toxin clinical trial", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Medical Director", "OverallOfficialAffiliation":"Allergan", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Arizona Neurological Institute", "LocationCity":"Scottsdale", "LocationState":"Arizona", "LocationZip":"85255-7450", "LocationCountry":"United States" },{ "LocationFacility":"The Research Center of Southern California, LLC", "LocationCity":"Encinitas", "LocationState":"California", "LocationZip":"92024", "LocationCountry":"United States" },{ "LocationFacility":"USC Neurology", "LocationCity":"Los Angeles", "LocationState":"California", "LocationZip":"90033", "LocationCountry":"United States" },{ "LocationFacility":"UCSF Headache Center", "LocationCity":"San Francisco", "LocationState":"California", "LocationZip":"94133", "LocationCountry":"United States" },{ "LocationFacility":"Neurological Research Institute", "LocationCity":"Santa Monica", "LocationState":"California", "LocationZip":"90404", "LocationCountry":"United States" },{ "LocationFacility":"Advanced Neurosciences Research, LLC", "LocationCity":"Fort Collins", "LocationState":"Colorado", "LocationZip":"80528", "LocationCountry":"United States" },{ "LocationFacility":"Tampa General Hospital", "LocationCity":"Tampa", "LocationState":"Florida", "LocationZip":"33606", "LocationCountry":"United States" },{ "LocationFacility":"Premiere Research Institute at Palm Beach Neurology", "LocationCity":"West Palm Beach", "LocationState":"Florida", "LocationZip":"33407", "LocationCountry":"United States" },{ "LocationFacility":"Robbins Headache Clinic", "LocationCity":"Northbrook", "LocationState":"Illinois", "LocationZip":"60062", "LocationCountry":"United States" },{ "LocationFacility":"Mid-Atlantic Headache Institute", "LocationCity":"Baltimore", "LocationState":"Maryland", "LocationZip":"21208", "LocationCountry":"United States" },{ "LocationFacility":"Kaiser Permanente Research Office/Neurology Department", "LocationCity":"Largo", "LocationState":"Maryland", "LocationZip":"20774", "LocationCountry":"United States" },{ "LocationFacility":"Clinvest Research", "LocationCity":"Springfield", "LocationState":"Missouri", "LocationZip":"65807-6988", "LocationCountry":"United States" },{ "LocationFacility":"Mercy Health Research", "LocationCity":"St. Louis", "LocationState":"Missouri", "LocationZip":"63141", "LocationCountry":"United States" },{ "LocationFacility":"Renown Institute for Neurosciences", "LocationCity":"Reno", "LocationState":"Nevada", "LocationZip":"89502", "LocationCountry":"United States" },{ "LocationFacility":"Dent Neurologic Institute", "LocationCity":"Amherst", "LocationState":"New York", "LocationZip":"14226", "LocationCountry":"United States" },{ "LocationFacility":"Montefiore Medical Center", "LocationCity":"Bronx", "LocationState":"New York", "LocationZip":"10461", "LocationCountry":"United States" },{ "LocationFacility":"Headache Wellness Center", "LocationCity":"Greensboro", "LocationState":"North Carolina", "LocationZip":"27405", "LocationCountry":"United States" },{ "LocationFacility":"Ohio Clinical Research Partners, LLC", "LocationCity":"Canton", "LocationState":"Ohio", "LocationZip":"44718", "LocationCountry":"United States" },{ "LocationFacility":"Jefferson University Hospitals", "LocationCity":"Philadelphia", "LocationState":"Pennsylvania", "LocationZip":"19107", "LocationCountry":"United States" },{ "LocationFacility":"Wesley Headache Clinic", "LocationCity":"Cordova", "LocationState":"Tennessee", "LocationZip":"38018", "LocationCountry":"United States" },{ "LocationFacility":"Baylor Research Institute", "LocationCity":"Dallas", "LocationState":"Texas", "LocationZip":"75231", "LocationCountry":"United States" },{ "LocationFacility":"Dr. Joseph Frasca", "LocationCity":"Adelaide", "LocationZip":"SA 5000", "LocationCountry":"Australia" },{ "LocationFacility":"Dr. Con Yiannikas", "LocationCity":"Burwood", "LocationZip":"NSW 2134", "LocationCountry":"Australia" },{ "LocationFacility":"Associate Professor Richard Stark", "LocationCity":"Melbourne", "LocationZip":"VIC 3000", "LocationCountry":"Australia" },{ "LocationFacility":"Richmmond Neurology", "LocationCity":"Richmond", "LocationZip":"VIC 3051", "LocationCountry":"Australia" },{ "LocationFacility":"Associate Professor John O'Sullivan", "LocationCity":"Spring Hill", "LocationZip":"QLD 4000", "LocationCountry":"Australia" },{ "LocationFacility":"Hallym University Sacred Heart Hospital", "LocationCity":"Dongan-gu, Anyang", "LocationState":"Anyang Gyeonggi-do", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Uijeongbu St. Mary's Hospital", "LocationCity":"Uijeongbu Si", "LocationState":"Gyeonggi-Do", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Kangbuk Samsung Hospital", "LocationCity":"Jongno-Gu", "LocationState":"Seoul", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Seoul St. Mary's Hospital", "LocationCity":"Jongno-Gu", "LocationState":"Seoul", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Seoul Eulji Hospital", "LocationCity":"Nowon-Gu", "LocationState":"Seoul", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Yonsei University Dental Hospital", "LocationCity":"Seodaemum-Gu", "LocationState":"Seoul", "LocationCountry":"Korea, Republic of" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"30630956", "ReferenceType":"derived", "ReferenceCitation":"Blumenfeld AM, Tepper SJ, Robbins LD, Manack Adams A, Buse DC, Orejudos A, D Silberstein S. Effects of onabotulinumtoxinA treatment for chronic migraine on common comorbidities including depression and anxiety. J Neurol Neurosurg Psychiatry. 2019 Mar;90(3):353-360. doi: 10.1136/jnnp-2018-319290. Epub 2019 Jan 10." },{ "ReferencePMID":"29404713", "ReferenceType":"derived", "ReferenceCitation":"Blumenfeld AM, Stark RJ, Freeman MC, Orejudos A, Manack Adams A. Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. J Headache Pain. 2018 Feb 5;19(1):13. doi: 10.1186/s10194-018-0840-8." },{ "ReferencePMID":"26133547", "ReferenceType":"derived", "ReferenceCitation":"Blumenfeld AM, Aurora SK, Laranjo K, Papapetropoulos S. Unmet clinical needs in chronic migraine: Rationale for study and design of COMPEL, an open-label, multicenter study of the long-term efficacy, safety, and tolerability of onabotulinumtoxinA for headache prophylaxis in adults with chronic migraine. BMC Neurol. 2015 Jul 3;15:100. doi: 10.1186/s12883-015-0353-x." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"BOTOX®", "FlowGroupDescription":"Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"716" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"373" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"343" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"25" } ] } },{ "FlowDropWithdrawType":"Lack of Efficacy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"35" } ] } },{ "FlowDropWithdrawType":"Pregnancy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"5" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"82" } ] } },{ "FlowDropWithdrawType":"Subject Withdrew Consent", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"92" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"60" } ] } },{ "FlowDropWithdrawType":"Other Miscellaneous Reasons", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"43" } ] } },{ "FlowDropWithdrawType":"Missing", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"All enrolled participants.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"BOTOX®", "BaselineGroupDescription":"Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas." } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"716" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"< 40 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"270" } ] } } ] } },{ "BaselineClassTitle":"≥ 40 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"446" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Gender", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"607" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"109" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline in the Frequency of Headache Days", "OutcomeMeasureDescription":"Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 108. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.", "OutcomeMeasurePopulationDescription":"Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"headache days", "OutcomeMeasureTimeFrame":"Baseline, Week 108", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"BOTOX®", "OutcomeGroupDescription":"Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"715" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"22.0", "OutcomeMeasurementSpread":"4.82" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at Week 108", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-10.7", "OutcomeMeasurementSpread":"6.44" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in the Frequency of Headache Days", "OutcomeMeasureDescription":"Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 60. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.", "OutcomeMeasurePopulationDescription":"Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"headache days", "OutcomeMeasureTimeFrame":"Baseline, Week 60", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"BOTOX®", "OutcomeGroupDescription":"Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"715" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"22.0", "OutcomeMeasurementSpread":"4.82" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at Week 60", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-9.2", "OutcomeMeasurementSpread":"6.22" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score", "OutcomeMeasureDescription":"The HIT-6 measures the impact of headache and treatment on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 4-week period. The total possible score ranges from 36 (no impact) to 78 (worst impact). A negative change from Baseline indicates an improvement, and a positive change from Baseline indicates a worsening.", "OutcomeMeasurePopulationDescription":"Participants from the Analysis Population, all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit, with data available for analysis.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"score on a scale", "OutcomeMeasureTimeFrame":"Baseline, Week 60, Week 108", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"BOTOX®", "OutcomeGroupDescription":"Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"713" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"64.7", "OutcomeMeasurementSpread":"4.82" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at Week 60", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-6.8", "OutcomeMeasurementSpread":"6.55" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at Week 108", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-7.1", "OutcomeMeasurementSpread":"7.24" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"108 Weeks", "EventsDescription":"Safety population included all participants who received at least one BOTOX® treatment injection.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"BOTOX®", "EventGroupDescription":"Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.", "EventGroupSeriousNumAffected":"75", "EventGroupSeriousNumAtRisk":"716", "EventGroupOtherNumAffected":"75" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Aortic valve incompetence", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"716" } ] } },{ "SeriousEventTerm":"Atrial fibrillation", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"716" } ] } },{ "SeriousEventTerm":"Cardiac failure congestive", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"716" } ] } },{ "SeriousEventTerm":"Congestive cardiomyopathy", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"716" } ] } },{ "SeriousEventTerm":"Myocardial infarction", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"716" } ] } },{ "SeriousEventTerm":"Cushing’s syndrome", "SeriousEventOrganSystem":"Endocrine disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"716" } ] } },{ "SeriousEventTerm":"Cataract subcapsular", "SeriousEventOrganSystem":"Eye disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"716" } ] } },{ "SeriousEventTerm":"Colitis ischaemic", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"716" } ] } },{ "SeriousEventTerm":"Colonic polyp", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"716" } ] } },{ "SeriousEventTerm":"Constipation", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"716" } ] } },{ "SeriousEventTerm":"Gastritis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"716" } ] } },{ "SeriousEventTerm":"Hiatus hernia", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"716" } ] } },{ "SeriousEventTerm":"Intestinal obstruction", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 15.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"716" } ] } },{ 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