Endpoint Hierarchy EndpointConceptsEndpoint TypePrimary CompanyOrganizationRepresentatives AllerganRobyn T Carson MPH Co Abdominal Pain Abdominal Discomfort Abdominal Bloating Stool ID: 938598
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Working Group ParticipantsBackgroundRationale for Irritable Bowel Syndrome (IBS) Working Group (WG) IBS is one of the most commonly diagnosed GI disordersIBS lacks a standard “fitforpurpose” PRO instrument for assessing important patientexperienced signs and symptoms of IBSPRO Consortium member representatives and FDA advisors identified IBS as a priority area for the development of a PRO instrumentGoal of the IBS WGTo develop three PRO measures for patientreported symptoms in IBS with constipation (IBSC), IBS with diarrhea (IBSD), and IBS with mixed symptoms (IBSM) for use in clinical trials as a primary endpoint measure to establish treatment benefitTargeted Labeling LanguageProduct X is indicated in adults for the treatment of symptoms associated with irritable bowel syndrome [with constipation (IBSC), with diarrhea (IBSD), or mixed (IBSM)] Product X improved abdominal symptoms (as measured by the abdominal symptom Endpoint Hierarchy EndpointConcept(s)Endpoint TypePrimary Company/OrganizationRepresentatives AllerganRobyn T. Carson, MPH (Co Abdominal Pain *, Abdominal Discomfort *, Abdominal Bloating *, Stool Consistency *, StoolFrequency *, Incomplete BMs *, Recurrent BMs Urgency Abdominal Cramping Straining Abdominal Bowel MovementRelated SymptomsMeasures developed for each subtype:Diary for Irritable Bowel Syndrome SymptomsC (DIBSSC) for constipation predominantDiary for Irritable Bowel Syndrome SymptomsD (DIBSSD) for diarrhea predominantDiary for Irritable Bowel Syndrome SymptomsM (DIBSSM) for mixed symptomsCore Items: Abdominal symptoms and bowel movementrelated signs/symptomsRecall Period: Event driven and 24hour (end of day)Response Options: Verbal rating scales, bivariate response, 11point numeric rating scales MilestoneExpectedDateCompleted Date