{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"33"}]}],"title":"Any AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Serious AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Fatal AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"AE leading to study discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"AE leading to study drug discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"CTCAE Grade 3, 4, or 5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}],"title":"Any AE related to study drug"}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"}],"units":"Participants"}],"description":"An adverse event is defined as an undesirable medical occurrence (e.g., sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the participant at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The severity of adverse events was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) based on the following general guideline: Grade 1: Mild AE Grade 2: Moderate AE Grade 3: Severe AE Grade 4: Life-threatening or disabling AE Grade 5: Death related to AE. AEs were assessed by the Investigator for relatedness to study drug.","groups":[{"description":"Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.","id":"OG000","title":"Denosumab"}],"paramType":"NUMBER","populationDescription":"All participants who received at least 1 dose of denosumab.","reportingStatus":"POSTED","timeFrame":"From the first dose of study drug until the data cut-off date of April 7 2008; a maximum of 18 months","title":"Number of Participants With Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"participants"}