{ "FullStudy":{ "Rank":218054, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513330", "OrgStudyIdInfo":{ "OrgStudyId":"CP219" }, "Organization":{ "OrgFullName":"Coloplast A/S", "OrgClass":"INDUSTRY" }, "BriefTitle":"Performance Study of Newly Developed Ostomy Products", "OfficialTitle":"An Open-labelled, Randomised, Controlled, Crossover Investigation Evaluating Performance of a Newly Developed Ostomy Care Product Compared to Standard Care." }, "StatusModule":{ "StatusVerifiedDate":"November 2013", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"August 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 16, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"August 6, 2013", "ResultsFirstSubmitQCDate":"November 21, 2013", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"January 9, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 21, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 9, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Coloplast A/S", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Stoma Colostomy" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Prevention", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"122", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"First Standard Care, then SenSura Mio", "ArmGroupType":"Experimental", "ArmGroupDescription":"Subjects first test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) and after cross-over SenSura Mio", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: SenSura Mio", "Device: Standard Care" ] } },{ "ArmGroupLabel":"First SenSura Mio, then Standard Care", "ArmGroupType":"Experimental", "ArmGroupDescription":"Subjects first test SenSura Mio and after cross-over Standard Care(Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: SenSura Mio", "Device: Standard Care" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"SenSura Mio", "InterventionDescription":"Ostomy product - 1 piece closed bag", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "First SenSura Mio, then Standard Care", "First Standard Care, then SenSura Mio" ] } },{ "InterventionType":"Device", "InterventionName":"Standard Care", "InterventionDescription":"Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "First SenSura Mio, then Standard Care", "First Standard Care, then SenSura Mio" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)", "PrimaryOutcomeDescription":"Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.", "PrimaryOutcomeTimeFrame":"14 days" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHave given written informed consent.\nBe at least 18 years of age and have full legal capacity.\nHave experienced leakage under the base plate at least once a week over the last two weeks.\nBe able to handle the bags themselves or with help from caregiver (e.g. spouse).\nHave a colostomy with a diameter between 20 and 45 mm.\nHave had their ostomy for at least three months.\nCurrently use a 1-piece flat product with closed bag.\nUse minimum 1 product per day.\nBe suitable for participation in the investigation and for using a standard adhesive, flat base plate (evaluated by investigator).\n\nExclusion Criteria:\n\nUse irrigation during the study (flush the stoma with water).\nCurrently receiving or have within the past 2 months received radio- and/or chemotherapy.\nCurrently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.\nAre pregnant or breastfeeding.\nParticipating in other interventional clinical investigations or have previously participated in this investigation.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Wenche Sundberg, stoma nurse", "OverallOfficialAffiliation":"Diakonhjemmet Sykhus, Oslo", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Merete Bjørke, Stoma Nurse", "OverallOfficialAffiliation":"St. Olavs Hopsital", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Vigids Dagsland, Stoma Nurse", "OverallOfficialAffiliation":"Haugesund Sykhus", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Randi Melum, Stoma Nurse", "OverallOfficialAffiliation":"St. Olavs Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Publicare", "LocationCity":"Cologne", "LocationState":"Køln", "LocationCountry":"Germany" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowRecruitmentDetails":"The subjects were recruited via sites and user data-bases in Denmark, Norway, Germany and France.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"First SenSura Mio, Then Standard Care", "FlowGroupDescription":"The subjects first test SenSura Mio : Ostomy product - 1 piece closed bag and thereafter cross-over and test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"First Standard Care, Then SenSura Mio", "FlowGroupDescription":"The subjects first test Standard Care Ostomy product 1 piece closed bags (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)and after cross-over test SenSura Mio 1-piece closed bags." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"SenSura Mio First,", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"64" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"58" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"60" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"56" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"2" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lack of Efficacy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Other", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Standard Care First,", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"60" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"56" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"56" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"52" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"4" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Lack of Efficacy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Other", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Entire Study Population", "BaselineGroupDescription":"Entire study population = all participants enrolled in the study" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"122" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"65.3", "BaselineMeasurementSpread":"11.7" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"63" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"59" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)", "OutcomeMeasureDescription":"Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"points on a scale", "OutcomeMeasureTimeFrame":"14 days", "OutcomeMeasureTypeUnitsAnalyzed":"baseplates", "OutcomeMeasureDenomUnitsSelected":"Participants", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"SenSura Mio", "OutcomeGroupDescription":"SenSura Mio : Ostomy product - 1 piece closed bag" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Standard Care", "OutcomeGroupDescription":"Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"120" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"118" } ] } },{ "OutcomeDenomUnits":"baseplates", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"2852" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"2810" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.8", "OutcomeMeasurementSpread":"5.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.4", "OutcomeMeasurementSpread":"4.4" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"SenSura Mio", "EventGroupDescription":"SenSura Mio : Ostomy product - 1 piece closed bag", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"120", "EventGroupOtherNumAffected":"10", "EventGroupOtherNumAtRisk":"120" },{ "EventGroupId":"EG001", "EventGroupTitle":"Standard Care", "EventGroupDescription":"Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"118", "EventGroupOtherNumAffected":"10", "EventGroupOtherNumAtRisk":"118" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Itching", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"120" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"118" } ] } },{ "OtherEventTerm":"Peristomal skin redness", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"120" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"118" } ] } },{ "OtherEventTerm":"Peristomal skin erosion", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"120" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"118" } ] } },{ "OtherEventTerm":"Peristomal allergic contact dermatitis", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventNotes":"Not clinically verified allergic contact dermatitis.1 subject tested 21 Nova baseplates before the AE -allergic dermatitis.1 subject tested 8 SenSura Mio baseplates during 3 days before the AE -contact dermatitis because of allergic reaction occured.", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"120" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"118" } ] } },{ "OtherEventTerm":"Peristomal burns", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"120" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"118" } ] } },{ "OtherEventTerm":"Diarrhoea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"120" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"118" } ] } },{ "OtherEventTerm":"Infected toe", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"120" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"118" } ] } },{ "OtherEventTerm":"Consumption of food leading to skin irritation", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"120" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"118" } ] } },{ "OtherEventTerm":"Granulation in the peristomal area", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"120" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"118" } ] } },{ "OtherEventTerm":"Pain in the peristomal area", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"120" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"118" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Director of Clinical Trials", "PointOfContactOrganization":"Coloplast A/S", "PointOfContactEMail":"dkbir@coloplast.com", "PointOfContactPhone":"+45 4911 3595" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" } } } } }