{"description":"Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":197,"description":"F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.\n\nF-627: single dose pre-filled syringe","id":"EG000","otherNumAffected":70,"otherNumAtRisk":197,"seriousNumAffected":12,"seriousNumAtRisk":197,"title":"F-627"},{"deathsNumAffected":2,"deathsNumAtRisk":196,"description":"6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles\n\nNeulasta: single dose pre-filled syringe","id":"EG001","otherNumAffected":51,"otherNumAtRisk":196,"seriousNumAffected":3,"seriousNumAtRisk":196,"title":"Neulasta"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue 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22.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":197,"numEvents":26},{"groupId":"EG001","numAffected":12,"numAtRisk":196,"numEvents":18}],"term":"Asthenia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":197,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":196,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":197,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":196,"numEvents":0}],"term":"fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":197,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":196,"numEvents":0}],"term":"diabetic ketoacidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":197,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":196,"numEvents":0}],"term":"syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":197,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":196,"numEvents":0}],"term":"acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":197,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":196,"numEvents":0}],"term":"pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":197,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":196,"numEvents":0}],"term":"hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":197,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":196,"numEvents":0}],"term":"angioedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":197,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":196,"numEvents":0}],"term":"urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":197,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":197,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":197,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":197,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":197,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":196,"numEvents":1}],"term":"Hepatitis toxic"}],"timeFrame":"AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months)."}