{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"47"}]}],"title":"All TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"Serious TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Fatal TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}],"title":"TEAEs leading to IP discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}],"title":"CTCAE Grade 3, 4, or 5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"}]}],"title":"All TEAEs related to IP"}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"}],"units":"Participants"}],"description":"An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. An AE is considered as treatment-emergent if the AE occurs during the time period from the first dose of IP in this study through last dose of IP plus 30 days. TEAEs related to IP include only TEAEs for which the Investigator indicated there was a reasonable possibility they may have been caused by IP. AEs were graded (grade 3 \\[severe or medically significant but not immediately life-threatening\\], 4 \\[life-threatening\\], and 5 \\[death related to the AE\\]) using the Common Terminology Criteria for Adverse Events (CTCAE).","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"}],"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 Treatment-emergent Adverse Events (TEAE)","type":"SECONDARY","unitOfMeasure":"Count of Participants"}