{ "FullStudy":{ "Rank":218122, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512446", "OrgStudyIdInfo":{ "OrgStudyId":"2011.1.42" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-000290-31", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Evangelisches Krankenhaus Lutherhaus gGmbH", "OrgClass":"INDUSTRY" }, "BriefTitle":"Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy", "OfficialTitle":"Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy", "Acronym":"BILANZ" }, "StatusModule":{ "StatusVerifiedDate":"January 2019", "OverallStatus":"Terminated", "WhyStopped":"low recruitment rate", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"March 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"March 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 14, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"November 28, 2017", "ResultsFirstSubmitQCDate":"July 21, 2018", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"January 17, 2019", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"January 24, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 12, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Prof. Dr. med. Johannes Pfeilschifter", "ResponsiblePartyInvestigatorTitle":"Head of Department of Internal Medicine III", "ResponsiblePartyInvestigatorAffiliation":"Evangelisches Krankenhaus Lutherhaus gGmbH" }, "LeadSponsor":{ "LeadSponsorName":"Evangelisches Krankenhaus Lutherhaus gGmbH", "LeadSponsorClass":"INDUSTRY" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"German Federal Ministry of Education and Research", "CollaboratorClass":"OTHER_GOV" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.", "DetailedDescription":"Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Osteoporosis" ] }, "KeywordList":{ "Keyword":[ "Osteoporosis", "Osteoporotic fractures", "Bisphosphonate", "Pretreatment with bisphosphonates" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"436", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Alendronate", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Alendronate" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Alendronate", "InterventionDescription":"70 mg per week", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Alendronate" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Fosamax" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"1 pill per week", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Number of New Osteoporotic Fractures", "PrimaryOutcomeDescription":"Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes.", "PrimaryOutcomeTimeFrame":"From baseline to study termination (mean duration 5.6 months)" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Mortality", "SecondaryOutcomeDescription":"Number of deaths", "SecondaryOutcomeTimeFrame":"From baseline to study termination (mean duration 5.6 months)" },{ "SecondaryOutcomeMeasure":"Combination of New Osteoporotic Fractures and Deaths", "SecondaryOutcomeDescription":"Number of participants with a new osteoporotic fracture or death", "SecondaryOutcomeTimeFrame":"From baseline to study termination (mean duration 5.6 months)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPostmenopausal women or men > 60 years\nDXA T-Score at lumbar spine, total hip or femur neck <-2,0 before the start of the bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral densitiy\nPretreatment with bisphosphonates for at least four years\nRisk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009\nSigned informed consent\n\nExclusion Criteria:\n\nOther pharmacological treatment of osteoporosis during the last 48 months\nOther bone diseases\nMalabsorption syndromes\nRenal insufficiency with a calculated creatinine clearance < 35 ml/min\nDiseases of the esophagus, delayed esophageal clearance\nUUnability to realise the intake instructions\nHypocalcemia", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"60 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Johannes Pfeilschifter, Prof. Dr. med.", "OverallOfficialAffiliation":"Alfried Krupp Krankenhaus Essen Steele", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Department of Internal Medicine III, Alfried Krupp Krankenhaus Essen Steele", "LocationCity":"Essen", "LocationZip":"45276", "LocationCountry":"Germany" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowRecruitmentDetails":"The study was early terminated due to a low recruitment rate", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Placebo", "FlowGroupDescription":"Placebo, administered orally once weekly" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Alendronate", "FlowGroupDescription":"Alendronate 70 mg, administered orally once weekly" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"221" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"215" } ] } },{ "FlowMilestoneType":"Safety Analysis Set", "FlowMilestoneComment":"Received at least one dose of study medication", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"197" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"188" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"221" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"215" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Placebo", "BaselineGroupDescription":"Placebo, administered orally once weekly" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Alendronate", "BaselineGroupDescription":"Alendronate 70 mg, administered orally once weekly" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"221" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"215" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"436" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"75.3", "BaselineMeasurementSpread":"6.9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"74.3", "BaselineMeasurementSpread":"7.1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"74.8", "BaselineMeasurementSpread":"7.0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"194" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"203" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"397" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"27" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"39" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Germany", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"221" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"215" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"436" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of New Osteoporotic Fractures", "OutcomeMeasureDescription":"Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes.", "OutcomeMeasurePopulationDescription":"Full Analysis Set (all randomized participants)", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"osteoporotic fractures", "OutcomeMeasureTimeFrame":"From baseline to study termination (mean duration 5.6 months)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo, administered orally once weekly" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Alendronate", "OutcomeGroupDescription":"Alendronate 70 mg, administered orally once weekly" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"221" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"215" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mortality", "OutcomeMeasureDescription":"Number of deaths", "OutcomeMeasurePopulationDescription":"Full Analysis Set (all randomized participants)", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"From baseline to study termination (mean duration 5.6 months)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo, administered orally once weekly" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Alendronate", "OutcomeGroupDescription":"Alendronate 70 mg, administered orally once weekly" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"221" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"215" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Combination of New Osteoporotic Fractures and Deaths", "OutcomeMeasureDescription":"Number of participants with a new osteoporotic fracture or death", "OutcomeMeasurePopulationDescription":"Full Analysis Set (all randomized participants)", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"From baseline to study termination (mean duration 5.6 months)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo, administered orally once weekly" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Alendronate", "OutcomeGroupDescription":"Alendronate 70 mg, administered orally once weekly" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"221" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"215" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Placebo", "EventGroupDescription":"Placebo, administered orally once weekly", "EventGroupSeriousNumAffected":"38", "EventGroupSeriousNumAtRisk":"197", "EventGroupOtherNumAffected":"113", "EventGroupOtherNumAtRisk":"197" },{ "EventGroupId":"EG001", "EventGroupTitle":"Alendronate", "EventGroupDescription":"Alendronate 70 mg, administered orally once weekly", "EventGroupSeriousNumAffected":"31", "EventGroupSeriousNumAtRisk":"188", "EventGroupOtherNumAffected":"94", "EventGroupOtherNumAtRisk":"188" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Microcytic anaemia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Acute coronary syndrome", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Cardiac failure", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Myocardial infarction", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Myocarditis", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Vertigo", "SeriousEventOrganSystem":"Ear and labyrinth disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Toxic nodular goitre", "SeriousEventOrganSystem":"Endocrine disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Abdominal pain", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Abdominal pain upper", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Diverticulitis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Gastric ulcer", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Gastrointestinal haemorrhage", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Pancreas infection", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Impaired healing", "SeriousEventOrganSystem":"General disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Pain", "SeriousEventOrganSystem":"General disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Liver disorder", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Atypical femur fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Facial bones fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Fall", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Femur fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Foot fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventNotes":"toe fracture", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Fractured sacrum", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventNotes":"knowledge about one fractured sacrum was obtained post-study.", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Hand fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Hip fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Overdose", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Pelvic fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventNotes":"1 pelvic fracture occurred within 30 days after study termination", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Pubis fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Rib fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Skull fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"197" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"188" } ] } },{ "SeriousEventTerm":"Spinal fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural 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