{"eventGroups":[{"deathsNumAffected":3,"deathsNumAtRisk":137,"description":"All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.\n\nLeuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate","id":"EG000","otherNumAffected":114,"otherNumAtRisk":137,"seriousNumAffected":20,"seriousNumAtRisk":137,"title":"Leuprolide Mesylate 50mg"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":137,"numEvents":10}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":137,"numEvents":13}],"term":"Injection site pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":137,"numEvents":9}],"term":"Nasopharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":137,"numEvents":12}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":137,"numEvents":7}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":137,"numEvents":18}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":137,"numEvents":9}],"term":"Nocturia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":67,"numAtRisk":137,"numEvents":69}],"term":"Hot flush"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":137,"numEvents":23}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":2}],"term":"Angina pectoris"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Myocardial infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Vertigo"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Vision blurred"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Dysphagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Death"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Bronchitis bacterial"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Clostridium difficile colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Hip fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Joint dislocation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":137,"numEvents":2}],"term":"Subdural haematoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Osteoarthritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Colon adenoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Colon cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Prostate cancer metastatic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Cerebrovascular accident"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Metabolic encephalopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Acute respiratory failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Asthma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":3}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Pneumothorax spontaneous"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Diabetic foot"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Intermittent claudication"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":2}],"term":"Peripheral artery occlusion"}],"timeFrame":"336 days"}