{"description":"Safety analysis set included all participants who received at least 1 dose of study intervention.","eventGroups":[{"deathsNumAffected":4,"deathsNumAtRisk":31,"description":"Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.","id":"EG000","otherNumAffected":28,"otherNumAtRisk":31,"seriousNumAffected":5,"seriousNumAtRisk":31,"title":"Apalutamide + Goserelin"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 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24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31}],"term":"Malaise"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Upper Respiratory Tract Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Radiation Skin Injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Blood Creatinine Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31}],"term":"Blood Thyroid Stimulating Hormone Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31}],"term":"Weight Decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Decreased Appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31}],"term":"Hypertriglyceridaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 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24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Dysphonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31}],"term":"Dry Skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":31}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":31}],"term":"Rash Maculo-Papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31}],"term":"Hot Flush"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Oesophageal Stenosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Cancer Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Cerebral Infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Hydronephrosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Laryngeal Oedema"}],"timeFrame":"Up to 13 months"}