{"description":"The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.","eventGroups":[{"description":"Participants received a dose loading regimen of 3 subcutaneous injections of denosumab 120 mg every week for 3 weeks (study Days 1, 8, and 15), followed by a week of rest, and then 120 mg denosumab once every 4 weeks (Q4W) from Day 29.","id":"EG000","otherNumAffected":25,"otherNumAtRisk":37,"seriousNumAffected":5,"seriousNumAtRisk":37,"title":"Denosumab 120 mg Q4W"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":37}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":37}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":37}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":37}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":37}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":37}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":37}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":37}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":37}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":37}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":37}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":37}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":37}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":37}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":37}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":37}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":37}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":37}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":37}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":37}],"term":"Cough"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":37}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":37}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":37}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":37}],"term":"Ankle fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":37}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":37}],"term":"Metastases to lung"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":37}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":37}],"term":"Acute respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 11.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":37}],"term":"Dyspnoea"}],"timeFrame":"up to 1 year 6 months"}