{ "FullStudy":{ "Rank":217994, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514136", "OrgStudyIdInfo":{ "OrgStudyId":"CP216" }, "Organization":{ "OrgFullName":"Coloplast A/S", "OrgClass":"INDUSTRY" }, "BriefTitle":"An Investigation of Ostomy Devices", "OfficialTitle":"CP216: An Exploratory Investigation of Convex Ostomy Devices" }, "StatusModule":{ "StatusVerifiedDate":"February 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"September 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2011", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"January 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"January 19, 2015", "ResultsFirstSubmitQCDate":"January 19, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"January 29, 2015", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 20, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 11, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Coloplast A/S", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Coloplast A/S has developed a new ostomy device in 8 versions.\n\nThe primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices.\n\nThe secondary objective is to investigate several performance and safety parameters of the various devices.\n\nThe aim of the primary and secondary objectives is to acquire more knowledge about the performance of the newly developed device and inspiration for their further development, if needed.\n\nGiven that the investigation is exploratory, pass/fail criteria are not relevant. The investigation result will provide knowledge useful for continued decision-making/device development.\n\nThe investigation is designed as a non-blinded, controlled, exploratory investigation that includes a total of 30-40 Danish ileostomy users.\n\nEach subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each device will be tested for 7 (± 2) days." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Ileostomy" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"32", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"One arm", "ArmGroupType":"Experimental", "ArmGroupDescription":"The arm consists of two periods: in period one, products are tested in the order A, B, C, D, and in period two, products are tested in the order A*, B*, C*, D*.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Ostomy appliance: convex 1-piece drainable" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Ostomy appliance: convex 1-piece drainable", "InterventionDescription":"8 variations of an ostomy devices are tested", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "One arm" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Degree of Leakage", "PrimaryOutcomeDescription":"The degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate.\n\nThe scale was developed by Coloplast A/S", "PrimaryOutcomeTimeFrame":"One week" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nBe at least 18 years old\nHave signed the declaration of informed consent\nHave an ileostomy in a concave area\nHave had an ileostomy for at least three months\nHave used convex plates (for convex users) or flat plates (for flat plate users) for the last month\nBe users of 1-piece or 2-piece open ostomy devices\nHave an ileostomy with a diameter of less than 33 mm\n\nExclusion Criteria:\n\nAre pregnant or breast-feeding\nHave a double-loop ileostomy\nHave known hypersensitivity or allergy to the devices' component ingredients\nAre receiving/have received radiation treatment and/or chemotherapy within the last 3 months.\nAre receiving/have received local peristomal or systemic steroid treatment within the last month\nSuffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Birte P Jakobsen, MD", "OverallOfficialAffiliation":"Coloplast A/S", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Coloplast A/S", "LocationCity":"Humlebaek", "LocationZip":"3050", "LocationCountry":"Denmark" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"The investigation consisted of two periods: in the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts, Test A*-D*, were developed and tested. The test products were not randomised. The test order in first round was Test A - Test D and in second round it was Test A*-Test D*.", "FlowRecruitmentDetails":"The subject were recruited through the Coloplast A/S user database in Denmark.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Test A", "FlowGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTherefore the participant flow is divided by the test products and not for each period.\n\nTest A was a newly developed concept by Coloplast A/S for the first round." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Test B", "FlowGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTherefore the participant flow is divided by the test products and not for each period.\n\nTest B was a newly developed concept by Coloplast A/S for the first round." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Test C", "FlowGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTherefore the participant flow is divided by the test products and not for each period.\n\nTest C was a newly developed concept by Coloplast A/S for the first round." },{ "FlowGroupId":"FG003", "FlowGroupTitle":"Test D", "FlowGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTherefore the participant flow is divided by the test products and not for each period.\n\nTest D was a newly developed concept by Coloplast A/S for the first round." },{ "FlowGroupId":"FG004", "FlowGroupTitle":"Test A*", "FlowGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTherefore the participant flow is divided by the test products and not for each period.\n\nTest A* was a newly developed optimized concept by Coloplast A/S for the second round." },{ "FlowGroupId":"FG005", "FlowGroupTitle":"Test B*", "FlowGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTherefore the participant flow is divided by the test products and not for each period.\n\nTest B* was a newly developed optimized concept by Coloplast A/S for the second round." },{ "FlowGroupId":"FG006", "FlowGroupTitle":"Test C*", "FlowGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTherefore the participant flow is divided by the test products and not for each period.\n\nTest C* was a newly developed optimized concept by Coloplast A/S for the second round." },{ "FlowGroupId":"FG007", "FlowGroupTitle":"Test D*", "FlowGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTherefore the participant flow is divided by the test products and not for each period.\n\nTest D* was a newly developed optimized concept by Coloplast A/S for the second round." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Test Period 1; Test A", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"26 subjects tested Test A", "FlowAchievementNumSubjects":"25" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"22" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Break from study holiday", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Test Period 1; Test B", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"2 new subjects were entered the investigation", "FlowAchievementNumSubjects":"24" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"23" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Test Period 1; Test C", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementComment":"1 new subject was included in the investigation", "FlowAchievementNumSubjects":"24" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"24" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Test Period 1; Test D", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementComment":"The two subject that were on holiday after test A re-entered the investigation", "FlowAchievementNumSubjects":"26" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"24" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Subject took a break due to holiday", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Test Period 2; Test A*", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementComment":"4 new subjects were included in the investigation", "FlowAchievementNumSubjects":"28" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"26" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Holiday", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Test Period 2; Test B*", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementComment":"Two subjects did not test test A*, but had a break and continued again on Test B*", "FlowAchievementNumSubjects":"28" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"26" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Test Period 2; Test C*", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"26" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"23" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"holiday", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Test Period; Test D*", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"23" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"23" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Convex Product Users", "BaselineGroupDescription":"Subjects who usually use a convex product" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Flat Product Users", "BaselineGroupDescription":"Subjects who usually use a flat product" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"23" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"9" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"32" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"59.3", "BaselineMeasurementSpread":"11.9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"64.4", "BaselineMeasurementSpread":"7.5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"60.8", "BaselineMeasurementSpread":"11.0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"18" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"23" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"9" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Degree of Leakage", "OutcomeMeasureDescription":"The degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate.\n\nThe scale was developed by Coloplast A/S", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"One week", "OutcomeMeasureTypeUnitsAnalyzed":"baseplates", "OutcomeMeasureDenomUnitsSelected":"Participants", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Test A - Convex Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest A was a newly developed concept by Coloplast A/S for the first round." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Test B - Convex Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest B was a newly developed concept by Coloplast A/S for the first round." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Test C - Convex Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest C was a newly developed concept by Coloplast A/S for the first round." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Test D - Convex Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest D was a newly developed concept by Coloplast A/S for the first round." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Test A* - Convex Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest A* was a newly developed optimized concept by Coloplast A/S for the second round." },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Test B* - Convex Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest B* was a newly developed optimized concept by Coloplast A/S for the second round." },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Test C* - Convex Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest C* was a newly developed optimized concept by Coloplast A/S for the second round." },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Test D* - Convex Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest D* was a newly developed optimized concept by Coloplast A/S for the second round." },{ "OutcomeGroupId":"OG008", "OutcomeGroupTitle":"Test A - Flat Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest A was a newly developed concept by Coloplast A/S for the first round." },{ "OutcomeGroupId":"OG009", "OutcomeGroupTitle":"Test B - Flat Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest B was a newly developed concept by Coloplast A/S for the first round." },{ "OutcomeGroupId":"OG010", "OutcomeGroupTitle":"Test C - Flat Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest C was a newly developed concept by Coloplast A/S for the first round." },{ "OutcomeGroupId":"OG011", "OutcomeGroupTitle":"Test D - Flat Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest D was a newly developed concept by Coloplast A/S for the first round." },{ "OutcomeGroupId":"OG012", "OutcomeGroupTitle":"Test A* - Flat Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest A* was a newly developed optimized concept by Coloplast A/S for the second round." },{ "OutcomeGroupId":"OG013", "OutcomeGroupTitle":"Test B* - Flat Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest B* was a newly developed optimized concept by Coloplast A/S for the second round." },{ "OutcomeGroupId":"OG014", "OutcomeGroupTitle":"Test C* - Flat Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest C* was a newly developed optimized concept by Coloplast A/S for the second round." },{ "OutcomeGroupId":"OG015", "OutcomeGroupTitle":"Test D* - Flat Product Users", "OutcomeGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.\n\nTwo subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.\n\nTest D* was a newly developed optimized concept by Coloplast A/S for the second round." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"18" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"19" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"19" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"19" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"19" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"20" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"18" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"5" },{ "OutcomeDenomCountGroupId":"OG010", "OutcomeDenomCountValue":"5" },{ "OutcomeDenomCountGroupId":"OG011", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG012", "OutcomeDenomCountValue":"9" },{ "OutcomeDenomCountGroupId":"OG013", "OutcomeDenomCountValue":"8" },{ "OutcomeDenomCountGroupId":"OG014", "OutcomeDenomCountValue":"8" },{ "OutcomeDenomCountGroupId":"OG015", "OutcomeDenomCountValue":"7" } ] } },{ "OutcomeDenomUnits":"baseplates", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"99" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"98" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"111" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"92" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"104" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"89" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"87" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"86" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"36" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"32" },{ "OutcomeDenomCountGroupId":"OG010", "OutcomeDenomCountValue":"31" },{ "OutcomeDenomCountGroupId":"OG011", "OutcomeDenomCountValue":"43" },{ "OutcomeDenomCountGroupId":"OG012", "OutcomeDenomCountValue":"43" },{ "OutcomeDenomCountGroupId":"OG013", "OutcomeDenomCountValue":"42" },{ "OutcomeDenomCountGroupId":"OG014", "OutcomeDenomCountValue":"41" },{ "OutcomeDenomCountGroupId":"OG015", "OutcomeDenomCountValue":"35" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.2", "OutcomeMeasurementSpread":"0.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.3", "OutcomeMeasurementSpread":"0.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4.4", "OutcomeMeasurementSpread":"0.7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4.3", "OutcomeMeasurementSpread":"0.8" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"3.4", "OutcomeMeasurementSpread":"0.7" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"2.9", "OutcomeMeasurementSpread":"0.6" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"3.3", "OutcomeMeasurementSpread":"0.7" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"4.1", "OutcomeMeasurementSpread":"0.8" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"2.1", "OutcomeMeasurementSpread":"1.4" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0.1", "OutcomeMeasurementSpread":"0.04" },{ "OutcomeMeasurementGroupId":"OG010", "OutcomeMeasurementValue":"0.1", "OutcomeMeasurementSpread":"0.1" },{ "OutcomeMeasurementGroupId":"OG011", "OutcomeMeasurementValue":"2.4", "OutcomeMeasurementSpread":"1.3" },{ "OutcomeMeasurementGroupId":"OG012", "OutcomeMeasurementValue":"3.1", "OutcomeMeasurementSpread":"1.5" },{ "OutcomeMeasurementGroupId":"OG013", "OutcomeMeasurementValue":"3.6", "OutcomeMeasurementSpread":"1.8" },{ "OutcomeMeasurementGroupId":"OG014", "OutcomeMeasurementValue":"3.8", "OutcomeMeasurementSpread":"1.8" },{ "OutcomeMeasurementGroupId":"OG015", "OutcomeMeasurementValue":"3.0", "OutcomeMeasurementSpread":"1.6" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Test A", "EventGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.\n\nTest A was a newly developed concept by Coloplast A/S for the first round.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"26", "EventGroupOtherNumAffected":"8", "EventGroupOtherNumAtRisk":"26" },{ "EventGroupId":"EG001", "EventGroupTitle":"Test B", "EventGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.\n\nTest B was a newly developed concept by Coloplast A/S for the first round.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"24", "EventGroupOtherNumAffected":"6", "EventGroupOtherNumAtRisk":"24" },{ "EventGroupId":"EG002", "EventGroupTitle":"Test C", "EventGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.\n\nTest C was a newly developed concept by Coloplast A/S for the first round.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"24", "EventGroupOtherNumAffected":"4", "EventGroupOtherNumAtRisk":"24" },{ "EventGroupId":"EG003", "EventGroupTitle":"Test D", "EventGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.\n\nTest D was a newly developed concept by Coloplast A/S for the first round.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"26", "EventGroupOtherNumAffected":"3", "EventGroupOtherNumAtRisk":"26" },{ "EventGroupId":"EG004", "EventGroupTitle":"Test A*", "EventGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.\n\nTest A* was a newly developed optimized concept by Coloplast A/S for the second round.", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"28", "EventGroupOtherNumAffected":"3", "EventGroupOtherNumAtRisk":"28" },{ "EventGroupId":"EG005", "EventGroupTitle":"Test B*", "EventGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.\n\nTest B* was a newly developed optimized concept by Coloplast A/S for the second round.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"28", "EventGroupOtherNumAffected":"3", "EventGroupOtherNumAtRisk":"28" },{ "EventGroupId":"EG006", "EventGroupTitle":"Test C*", "EventGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.\n\nTest C* was a newly developed optimized concept by Coloplast A/S for the second round.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"26", "EventGroupOtherNumAffected":"1", "EventGroupOtherNumAtRisk":"26" },{ "EventGroupId":"EG007", "EventGroupTitle":"Test D*", "EventGroupDescription":"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.\n\nTest D* was a newly developed optimized concept by Coloplast A/S for the second round.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"23", "EventGroupOtherNumAffected":"3", "EventGroupOtherNumAtRisk":"23" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Chemotherapy, cancer in lymph nodes", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventNotes":"Not related to the product", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"28" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"28" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG007", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"23" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Perstomal skin irritation", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventNotes":"Related to the product", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"4", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"28" },{ "OtherEventStatsGroupId":"EG005", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"28" },{ "OtherEventStatsGroupId":"EG006", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG007", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"23" } ] } },{ "OtherEventTerm":"Cold or influenza", "OtherEventOrganSystem":"Infections and infestations", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventNotes":"Not related to the product", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"4", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"28" },{ "OtherEventStatsGroupId":"EG005", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"28" },{ "OtherEventStatsGroupId":"EG006", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG007", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"23" } ] } },{ "OtherEventTerm":"Headache", "OtherEventOrganSystem":"General disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventNotes":"Not related to the product", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"28" },{ "OtherEventStatsGroupId":"EG005", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"28" },{ "OtherEventStatsGroupId":"EG006", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG007", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"23" } ] } },{ "OtherEventTerm":"Protocol deviation/not defined", "OtherEventOrganSystem":"Investigations", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventNotes":"Related or possibly related to the product", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"28" },{ "OtherEventStatsGroupId":"EG005", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"28" },{ "OtherEventStatsGroupId":"EG006", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG007", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"23" } ] } },{ "OtherEventTerm":"Cancer, therapy", "OtherEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventNotes":"Not related to the product", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"28" },{ "OtherEventStatsGroupId":"EG005", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"28" },{ "OtherEventStatsGroupId":"EG006", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG007", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"23" } ] } },{ "OtherEventTerm":"Infection, tooth", "OtherEventOrganSystem":"Infections and infestations", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventNotes":"Not related to the product", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"28" },{ "OtherEventStatsGroupId":"EG005", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"28" },{ "OtherEventStatsGroupId":"EG006", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG007", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"23" } ] } },{ "OtherEventTerm":"Liver values, increased", "OtherEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventNotes":"Not related to the product", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"28" },{ "OtherEventStatsGroupId":"EG005", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"28" },{ "OtherEventStatsGroupId":"EG006", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG007", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"23" } ] } } ] } }, "MoreInfoModule":{ "LimitationsAndCaveats":{}, "CertainAgreement":{ "AgreementPISponsorEmployee":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"Birte Petersen Jakobsen, MD", "PointOfContactOrganization":"Coloplast A/S", "PointOfContactEMail":"dkbir@coloplast.com", "PointOfContactPhone":"+45 4911 1990" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" } } } } }