{"description":"Adverse events were reported for the safety analysis population, which was defined as all enrolled patients who received any amount of study drug.","eventGroups":[{"deathsNumAffected":35,"deathsNumAtRisk":104,"description":"Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.","id":"EG000","otherNumAffected":103,"otherNumAtRisk":104,"seriousNumAffected":36,"seriousNumAtRisk":104,"title":"Metastatic and Locally Advanced Basal-Cell Carcinoma"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":104}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":104}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":104}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":104}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":104}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":104}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":104}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":104}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":104}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":104}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":104}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":104}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":104}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":104}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":75,"numAtRisk":104}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":104}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":104}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":104}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":104}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":104}],"term":"Squamous cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":58,"numAtRisk":104}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":104}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":104}],"term":"Ageusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":104}],"term":"Hypogeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":104}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":104}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":104}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":104}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":104}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":104}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":104}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":104}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":69,"numAtRisk":104}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":104}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":104}],"term":"Hair growth abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":104}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":104}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":104}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":104}],"term":"Actinic keratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":104}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":104}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":104}],"term":"Pain"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Left ventricular dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Restrictive cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Eye haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Aphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Cholestasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":104}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Meningitis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Cervical vertebral fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Spinal compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Malignant melanoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Metastatic malignant melanoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Metastatic squamous cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Oesophageal carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Sarcoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104}],"term":"Squamous cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Convulsion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Ischaemic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":104}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Hypovolaemic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Orthostatic hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Cardiac flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Ulcerative keratitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Food poisoning"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Osteomyelitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":104}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Ankle fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Rib fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Toxicity to various agents"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Upper limb fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Metastases to meninges"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Cerebral haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Transient ischaemic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Suicidal ideation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":104}],"term":"Death"}],"timeFrame":"For all-cause mortality, deaths were recorded from enrollment through the end of treatment-free survival follow-up (up to 5 years, 2 months). Adverse events and serious adverse events were recorded from enrollment through 45 days after the last dose of study drug or study discontinuation/termination, whichever is later (up to 4 years, 7 months)."}