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17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1690},{"groupId":"EG001","numAffected":0,"numAtRisk":1709},{"groupId":"EG002","numAffected":1,"numAtRisk":245},{"groupId":"EG003","numAffected":0,"numAtRisk":1}],"term":"Vulval cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1690},{"groupId":"EG001","numAffected":0,"numAtRisk":1709},{"groupId":"EG002","numAffected":1,"numAtRisk":245},{"groupId":"EG003","numAffected":0,"numAtRisk":1}],"term":"Paresis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1690},{"groupId":"EG001","numAffected":0,"numAtRisk":1709},{"groupId":"EG002","numAffected":1,"numAtRisk":245},{"groupId":"EG003","numAffected":0,"numAtRisk":1}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1690},{"groupId":"EG001","numAffected":0,"numAtRisk":1709},{"groupId":"EG002","numAffected":1,"numAtRisk":245},{"groupId":"EG003","numAffected":0,"numAtRisk":1}],"term":"Hydrometra"}],"timeFrame":"Double-blind (DB) phase: from 1st dose of study drug to 30 days after last dose; Open-label (OL) phase: from 1st dose of OL study drug to 30 days after last dose. Median duration of treatment in DB phase: Placebo 35.4 months and denosumab 35.5 months. Median duration of treatment in OL phase: 37 months"}