{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"260"},{"groupId":"OG001","value":"231"},{"groupId":"OG002","value":"12"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"98"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"5"}]}],"title":"Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"}]}],"title":"Fatal TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"1"}]}],"title":"TEAE leading to treatment phase discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"1"}]}],"title":"TEAE leading to study drug discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"6"}]}],"title":"CTCAE Grade 3, 4, or 5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"136"},{"groupId":"OG002","value":"9"}]}],"title":"Any TEAE related to study drug"}],"denoms":[{"counts":[{"groupId":"OG000","value":"265"},{"groupId":"OG001","value":"249"},{"groupId":"OG002","value":"12"}],"units":"Participants"}],"description":"AE defined as any untoward medical occurrence in a clinical trial participant. Serious AE defined as AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other significant medical hazard. Severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE, v3.0) based on the general guideline: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to AE. Investigator assessed AEs for relatedness to study drug. Results are presented for treatment-emergent events (TEAEs) and included all AEs occurring from first dose in initial treatment phase to end of initial treatment phase (or for participants entering retreatment, from first dose in initial treatment phase until end of retreatment phase).","groups":[{"description":"Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 mg SC once Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.","id":"OG000","title":"Cohort 1 (Denosumab 120 mg Q4W)"},{"description":"Participants with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy) were enrolled into cohort 2 and received denosumab 120 mg SC Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.","id":"OG001","title":"Cohort 2 (Denosumab 120 mg Q4W)"},{"description":"Participants who participated in study 20040215 and were eligible to enroll in the current study (20062004) for continuation of treatment were enrolled into cohort 3 and received denosumab 120 mg SC Q4W, starting on study day 1. Participants in cohort 3 did not receive loading doses of denosumab on days 8 and 15 in the first month of treatment.","id":"OG002","title":"Cohort 3 (Denosumab 120 mg Q4W)"}],"paramType":"NUMBER","populationDescription":"The safety analysis set included all enrolled participants who received at least one dose of denosumab on the study.","reportingStatus":"POSTED","timeFrame":"From first dose of study drug up to last study visit for treatment-emergent period (a maximum of approximately 111 months).","title":"Number of Participants With Treatment-Emergent Adverse Events (TEAEs)","type":"PRIMARY","unitOfMeasure":"Participants"}