{"eventGroups":[{"deathsNumAffected":62,"deathsNumAtRisk":125,"description":"Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study\n\nIn Combination With:\n\nPemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Route of Administration: Intravenous Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous\n\nADI-PEG 20 plus Pem Platinum: Investigational Drug in combination approved standard of care treatment for this indication","id":"EG000","otherNumAffected":106,"otherNumAtRisk":125,"seriousNumAffected":19,"seriousNumAtRisk":125,"title":"Drug: ADI-PEG 20 Plus Pem Platinum"},{"deathsNumAffected":61,"deathsNumAtRisk":124,"description":"Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study\n\nIn Combination With:\n\nPemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 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(19.0)","stats":[{"groupId":"EG000","numAffected":66,"numAtRisk":125,"numEvents":106},{"groupId":"EG001","numAffected":62,"numAtRisk":124,"numEvents":111}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":125,"numEvents":106},{"groupId":"EG001","numAffected":41,"numAtRisk":124,"numEvents":111}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":125,"numEvents":106},{"groupId":"EG001","numAffected":38,"numAtRisk":124,"numEvents":111}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":125,"numEvents":106},{"groupId":"EG001","numAffected":44,"numAtRisk":124,"numEvents":111}],"term":"Decreased Appetite"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":125,"numEvents":19},{"groupId":"EG001","numAffected":6,"numAtRisk":124,"numEvents":20}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":125,"numEvents":15},{"groupId":"EG001","numAffected":8,"numAtRisk":124,"numEvents":11}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125,"numEvents":9},{"groupId":"EG001","numAffected":7,"numAtRisk":124,"numEvents":16}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":125,"numEvents":10},{"groupId":"EG001","numAffected":2,"numAtRisk":124,"numEvents":7}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":125,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":124,"numEvents":0}],"term":"Atrial Fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":125,"numEvents":6},{"groupId":"EG001","numAffected":4,"numAtRisk":124,"numEvents":4}],"term":"Acute Kidney Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":125,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":124,"numEvents":6}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":125,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":124,"numEvents":5}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":124,"numEvents":7}],"term":"Musculoskeletal Testing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":124,"numEvents":6}],"term":"Cerebrovascular Accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":124,"numEvents":2}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":125,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":124,"numEvents":4}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":125,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":124,"numEvents":2}],"term":"Deep Vein Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":124,"numEvents":0}],"term":"Anaphylactic Reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":125,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":124,"numEvents":2}],"term":"Confusional State"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125,"numEvents":19},{"groupId":"EG001","numAffected":6,"numAtRisk":124,"numEvents":20}],"term":"Sepsis"}],"timeFrame":"Treatment-emergent AEs were collected with onset after the first dose of study drug or existing events that worsened after the first dose during the study, approximately 18 months."}