{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]}],"title":"Adjudicated positive ONJ"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"1"}]}],"title":"Malignancy, including malignancy in GCTB"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"Adjudicated positive AFF"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]}],"title":"Hypocalcemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Hypocalcemia after treatment end"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Pregnancy and lactation"}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"34"}],"units":"Participants"}],"description":"EOIs assessed in the study were signs and symptoms of osteonecrosis of the jaw (ONJ), malignancy (including malignancy in GCTB), atypical femoral fracture (AFF), hypocalcemia, hypercalcemia after treatment discontinuation, pregnancy and lactation (if occurring during treatment or within 5 months of the last dose of denosumab). Hypocalcemia includes events that occurred after 30 days following the last dose of IP and includes TEAEs only. Other EOIs encompass all events from signing the informed consent to the end of the study (approximately 5 years). ONJ and AFF events were adjudicated by independent reviewers.","groups":[{"description":"Participants who received denosumab at the conclusion of study 20062004 continued in this study (study 20140114), and received denosumab at the current dose (120 mg Q4W SC) and schedule at the investigator's discretion.","id":"OG000","title":"Exposed to IP"},{"description":"Participants who completed denosumab treatment in study 20062004 and were in the safety follow up at the conclusion of study 20062004 continued in long term safety follow up in this study (study 20140114), and did not receive denosumab.","id":"OG001","title":"Not Exposed to IP"}],"paramType":"NUMBER","populationDescription":"FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study.","reportingStatus":"POSTED","timeFrame":"Up to approximately 5 years","title":"Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI)","type":"PRIMARY","unitOfMeasure":"Count of Participants"}