{ "FullStudy":{ "Rank":217600, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519284", "OrgStudyIdInfo":{ "OrgStudyId":"BIA-91067-114" }, "Organization":{ "OrgFullName":"Bial - Portela C S.A.", "OrgClass":"INDUSTRY" }, "BriefTitle":"Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic", "OfficialTitle":"A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects" }, "StatusModule":{ "StatusVerifiedDate":"July 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2009" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2010", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2011", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"July 22, 2015", "ResultsFirstSubmitQCDate":"July 22, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"August 20, 2015", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 22, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 20, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Bial - Portela C S.A.", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.", "DetailedDescription":"Single-centre, double-blind, randomised, parallel-group study in 80 young male and female healthy subjects." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Parkinson Disease" ] }, "KeywordList":{ "Keyword":[ "Parkinson Disease", "BIA 9-1067" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"82", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Group 1", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo at all the dosing times", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } },{ "ArmGroupLabel":"Group 2", "ArmGroupType":"Experimental", "ArmGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: BIA 9-1067 5 mg", "Drug: Placebo", "Drug: levodopa/carbidopa" ] } },{ "ArmGroupLabel":"Group 3", "ArmGroupType":"Experimental", "ArmGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo", "Drug: levodopa/carbidopa", "Drug: BIA 9-1067 15 mg" ] } },{ "ArmGroupLabel":"Group 4", "ArmGroupType":"Experimental", "ArmGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo", "Drug: levodopa/carbidopa", "Drug: BIA 9-1067 30 mg" ] } },{ "ArmGroupLabel":"Group 5", "ArmGroupType":"Experimental", "ArmGroupDescription":"Day 1 to 7:\n\nPlacebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nPlacebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Entacapone", "Drug: Placebo", "Drug: levodopa/carbidopa" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"BIA 9-1067 5 mg", "InterventionDescription":"BIA 9-1067 OPC, Opicapone 5 mg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Group 2" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "OPC, Opicapone" ] } },{ "InterventionType":"Drug", "InterventionName":"Entacapone", "InterventionDescription":"Entacapone 200 mg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Group 5" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"placebo (four times a day)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Group 1", "Group 2", "Group 3", "Group 4", "Group 5" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "PLC, placebo" ] } },{ "InterventionType":"Drug", "InterventionName":"levodopa/carbidopa", "InterventionDescription":"standard release levodopa/carbidopa 100/25 mg (single-dose)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Group 2", "Group 3", "Group 4", "Group 5" ] } },{ "InterventionType":"Drug", "InterventionName":"BIA 9-1067 15 mg", "InterventionDescription":"BIA 9-1067 OPC, Opicapone 15 mg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Group 3" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "OPC, Opicapone" ] } },{ "InterventionType":"Drug", "InterventionName":"BIA 9-1067 30 mg", "InterventionDescription":"BIA 9-1067 OPC, Opicapone 30 mg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Group 4" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "OPC, Opicapone" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Cmax - Maximum Plasma Concentration of Levodopa", "PrimaryOutcomeDescription":"Cmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days", "PrimaryOutcomeTimeFrame":"8 days" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Tmax - Time to Reach Maximum Plasma Concentration of Levodopa", "SecondaryOutcomeDescription":"Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days.", "SecondaryOutcomeTimeFrame":"8 days" },{ "SecondaryOutcomeMeasure":"AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification.", "SecondaryOutcomeDescription":"AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days", "SecondaryOutcomeTimeFrame":"8 days" },{ "SecondaryOutcomeMeasure":"AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity", "SecondaryOutcomeDescription":"AUC0-∞ - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to infinity.", "SecondaryOutcomeTimeFrame":"8 days" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAble and willing to give written informed consent.\nMale or female subjects aged between 18 and 45 years, inclusive.\nSubjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.\nHealthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.\nNegative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.\nClinical laboratory test results clinically acceptable at screening and admission to the treatment period.\nNegative screen for alcohol and drugs of abuse at screening and admission to the treatment period.\nNon-smokers or ex-smokers for at least 3 months.\n(If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: intrauterine device (by the subject) and condoms (by the partner) or diaphragm (by the subject) and condoms (by the partner) or spermicide (by the subject) and condoms (by the partner).\n(If female) She had a negative urine pregnancy test at screening and admission to the treatment period.\n\nExclusion Criteria:\n\nClinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.\nClinically relevant surgical history.\nAny abnormality in the coagulation tests.\nAny abnormality in the liver function tests.\nA history of relevant atopy or drug hypersensitivity.\nA history or presence of narrow-angle glaucoma.\nA suspicious undiagnosed skin lesions or a history of melanoma.\nHistory of alcoholism or drug abuse.\nConsumed more than 14 units of alcohol a week.\nSignificant infection or known inflammatory process at screening or admission to the treatment period.\nAcute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the treatment period.\nHad used non-selective monoamine oxidase (MAO) inhibitors within 2 weeks of admission to the treatment period.\nHad used medicines within 2 weeks of admission to the treatment period that may have affected the safety or other study assessments, in the investigator's opinion.\nHad previously received BIA 9-1067.\nHad used any investigational drug or participated in any clinical trial within 6 months prior to screening.\nHad participated in more than 2 clinical trials within the 12 months prior to screening.\nHad donated or received any blood or blood products within the 3 months prior to screening.\nVegetarians, vegans or had medical dietary restrictions.\nCannot communicate reliably with the investigator.\nUnlikely to co-operate with the requirements of the study.\nUnwilling or unable to gave written informed consent.\n(If female) She was pregnant or breast-feeding.\n(If female) She was of childbearing potential and she did not use an approved effective contraceptive method or she used oral contraceptives.", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"45 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Manuel Vaz-da-Silva, MD, PhD", "OverallOfficialAffiliation":"BIAL - Portela & Cª S.A", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Bial - Portela & Cª, S.A.", "LocationCity":"S. Mamede do Coronado", "LocationZip":"4745-457", "LocationCountry":"Portugal" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Group 1", "FlowGroupDescription":"Placebo at all the dosing times" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Group 2", "FlowGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose" },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Group 3", "FlowGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose" },{ "FlowGroupId":"FG003", "FlowGroupTitle":"Group 4", "FlowGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose" },{ "FlowGroupId":"FG004", "FlowGroupTitle":"Group 5", "FlowGroupDescription":"Day 1 to 7:\n\nPlacebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nPlacebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"18" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"16" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"16" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Group 1", "BaselineGroupDescription":"Placebo at all the dosing times\n\nPlacebo: placebo (four times a day)" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Group 2", "BaselineGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose\n\nBIA 9-1067 5 mg: BIA 9-1067 OPC, Opicapone 5 mg\n\nPlacebo: placebo (four times a day)\n\nlevodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Group 3", "BaselineGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose\n\nPlacebo: placebo (four times a day)\n\nlevodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)\n\nBIA 9-1067 15 mg: BIA 9-1067 OPC, Opicapone 15 mg" },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Group 4", "BaselineGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose\n\nPlacebo: placebo (four times a day)\n\nlevodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)\n\nBIA 9-1067 30 mg: BIA 9-1067 OPC, Opicapone 30 mg" },{ "BaselineGroupId":"BG004", "BaselineGroupTitle":"Group 5", "BaselineGroupDescription":"Day 1 to 7:\n\nPlacebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nPlacebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose\n\nEntacapone: Entacapone 200 mg\n\nPlacebo: placebo (four times a day)\n\nlevodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)" },{ "BaselineGroupId":"BG005", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"16" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"16" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"18" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"16" },{ "BaselineDenomCountGroupId":"BG004", "BaselineDenomCountValue":"16" },{ "BaselineDenomCountGroupId":"BG005", "BaselineDenomCountValue":"82" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"18" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"82" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"41" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"41" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Cmax - Maximum Plasma Concentration of Levodopa", "OutcomeMeasureDescription":"Cmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng/mL", "OutcomeMeasureTimeFrame":"8 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group 1", "OutcomeGroupDescription":"Placebo at all the dosing times" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group 2", "OutcomeGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Group 3", "OutcomeGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Group 4", "OutcomeGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose" },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Group 5", "OutcomeGroupDescription":"Day 1 to 7:\n\nPlacebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nPlacebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"16" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1076", "OutcomeMeasurementSpread":"292.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1106", "OutcomeMeasurementSpread":"420.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"943", "OutcomeMeasurementSpread":"325.3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"981", "OutcomeMeasurementSpread":"488.5" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"928", "OutcomeMeasurementSpread":"245" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Tmax - Time to Reach Maximum Plasma Concentration of Levodopa", "OutcomeMeasureDescription":"Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"hours", "OutcomeMeasureTimeFrame":"8 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group 1", "OutcomeGroupDescription":"Placebo at all the dosing times" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group 2", "OutcomeGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Group 3", "OutcomeGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Group 4", "OutcomeGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose" },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Group 5", "OutcomeGroupDescription":"Day 1 to 7:\n\nPlacebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nPlacebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"16" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.75", "OutcomeMeasurementLowerLimit":"0.25", "OutcomeMeasurementUpperLimit":"1.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.75", "OutcomeMeasurementLowerLimit":"0.25", "OutcomeMeasurementUpperLimit":"1.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.75", "OutcomeMeasurementLowerLimit":"0.25", "OutcomeMeasurementUpperLimit":"3.0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.75", "OutcomeMeasurementLowerLimit":"0.25", "OutcomeMeasurementUpperLimit":"1.0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0.75", "OutcomeMeasurementLowerLimit":"0.25", "OutcomeMeasurementUpperLimit":"1.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification.", "OutcomeMeasureDescription":"AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng.h/mL", "OutcomeMeasureTimeFrame":"8 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group 1", "OutcomeGroupDescription":"Placebo at all the dosing times" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group 2", "OutcomeGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Group 3", "OutcomeGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Group 4", "OutcomeGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose" },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Group 5", "OutcomeGroupDescription":"Day 1 to 7:\n\nPlacebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nPlacebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"16" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1578", "OutcomeMeasurementSpread":"320.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1785", "OutcomeMeasurementSpread":"574.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2102", "OutcomeMeasurementSpread":"569.6" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2202", "OutcomeMeasurementSpread":"605.6" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"2146", "OutcomeMeasurementSpread":"538.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity", "OutcomeMeasureDescription":"AUC0-∞ - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to infinity.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng.h/mL", "OutcomeMeasureTimeFrame":"8 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group 1", "OutcomeGroupDescription":"Placebo at all the dosing times" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group 2", "OutcomeGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Group 3", "OutcomeGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Group 4", "OutcomeGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose" },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Group 5", "OutcomeGroupDescription":"Day 1 to 7:\n\nPlacebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nPlacebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"16" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1649", "OutcomeMeasurementSpread":"313.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1873", "OutcomeMeasurementSpread":"571.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2233", "OutcomeMeasurementSpread":"578.3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2381", "OutcomeMeasurementSpread":"623.8" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"2253", "OutcomeMeasurementSpread":"540.7" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Group 1", "EventGroupDescription":"Placebo at all the dosing times", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"16", "EventGroupOtherNumAffected":"6", "EventGroupOtherNumAtRisk":"16" },{ "EventGroupId":"EG001", "EventGroupTitle":"Group 2", "EventGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"16", "EventGroupOtherNumAffected":"9", "EventGroupOtherNumAtRisk":"16" },{ "EventGroupId":"EG002", "EventGroupTitle":"Group 3", "EventGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"17", "EventGroupOtherNumAffected":"10", "EventGroupOtherNumAtRisk":"17" },{ "EventGroupId":"EG003", "EventGroupTitle":"Group 4", "EventGroupDescription":"Day 1 to 7:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nBIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"16", "EventGroupOtherNumAffected":"12", "EventGroupOtherNumAtRisk":"16" },{ "EventGroupId":"EG004", "EventGroupTitle":"Group 5", "EventGroupDescription":"Day 1 to 7:\n\nPlacebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose\n\nDay 8:\n\nPlacebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"16", "EventGroupOtherNumAffected":"7", "EventGroupOtherNumAtRisk":"16" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"spontaneous abortion", "SeriousEventOrganSystem":"Pregnancy, puerperium and perinatal conditions", "SeriousEventSourceVocabulary":"MedDRA, version 12.1", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"16" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"16" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"17" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"16" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"16" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Palpitations", "OtherEventOrganSystem":"Cardiac disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Conjunctivitis", "OtherEventOrganSystem":"Eye disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Edema eyelid", "OtherEventOrganSystem":"Eye disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Abdominal pain", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Abdominal pain upper", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Aerophagia", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Constipation", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Diarrhoea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Dyspepsia", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Flatulence", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Nausea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Rectal haemorrhage", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Vomiting", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Application site haematoma", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Catheter site phlebitis", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Device breakage", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Injection site haematoma", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Nasopharyngitis", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"17" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Pharyngitis", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA, version 12.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", 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