{"description":"Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":3,"description":"Patients were on observation and did not receive any treatment.","id":"EG000","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Arm A (Observation)"},{"deathsNumAffected":51,"deathsNumAtRisk":199,"description":"Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nCisplatin: Given IV","id":"EG001","otherNumAffected":141,"otherNumAtRisk":186,"seriousNumAffected":50,"seriousNumAtRisk":186,"title":"Arm B (Cisplatin or Carboplatin)"},{"deathsNumAffected":45,"deathsNumAtRisk":213,"description":"Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCapecitabine: Given PO","id":"EG002","otherNumAffected":165,"otherNumAtRisk":201,"seriousNumAffected":32,"seriousNumAtRisk":201,"title":"Arm C (Capecitabine)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":102,"numAtRisk":186},{"groupId":"EG002","numAffected":60,"numAtRisk":201}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":8,"numAtRisk":186},{"groupId":"EG002","numAffected":11,"numAtRisk":201}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":186},{"groupId":"EG002","numAffected":113,"numAtRisk":201}],"term":"Palmar-plantar erythrodysesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":35,"numAtRisk":186},{"groupId":"EG002","numAffected":22,"numAtRisk":201}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":12,"numAtRisk":186},{"groupId":"EG002","numAffected":90,"numAtRisk":201}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":86,"numAtRisk":186},{"groupId":"EG002","numAffected":80,"numAtRisk":201}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":28,"numAtRisk":186},{"groupId":"EG002","numAffected":24,"numAtRisk":201}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":105,"numAtRisk":186},{"groupId":"EG002","numAffected":50,"numAtRisk":201}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":47,"numAtRisk":186},{"groupId":"EG002","numAffected":55,"numAtRisk":201}],"term":"Peripheral sensory neuropathy"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":1,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Hearing impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":14,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":186},{"groupId":"EG002","numAffected":1,"numAtRisk":201}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":1,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Thrombotic thrombocytopenic purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":1,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Blood and lymphatic system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":186},{"groupId":"EG002","numAffected":1,"numAtRisk":201}],"term":"Cardiac disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":1,"numAtRisk":186},{"groupId":"EG002","numAffected":2,"numAtRisk":201}],"term":"Death NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":4,"numAtRisk":186},{"groupId":"EG002","numAffected":3,"numAtRisk":201}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":186},{"groupId":"EG002","numAffected":1,"numAtRisk":201}],"term":"General disorders and administration site conditions - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":186},{"groupId":"EG002","numAffected":10,"numAtRisk":201}],"term":"Palmar-plantar erythrodysesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":186},{"groupId":"EG002","numAffected":3,"numAtRisk":201}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":186},{"groupId":"EG002","numAffected":11,"numAtRisk":201}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":186},{"groupId":"EG002","numAffected":1,"numAtRisk":201}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":2,"numAtRisk":186},{"groupId":"EG002","numAffected":1,"numAtRisk":201}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":1,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":1,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Breast infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":1,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":1,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":186},{"groupId":"EG002","numAffected":1,"numAtRisk":201}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":1,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Wound complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":186},{"groupId":"EG002","numAffected":1,"numAtRisk":201}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":186},{"groupId":"EG002","numAffected":1,"numAtRisk":201}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":2,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":7,"numAtRisk":186},{"groupId":"EG002","numAffected":1,"numAtRisk":201}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":14,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":18,"numAtRisk":186},{"groupId":"EG002","numAffected":5,"numAtRisk":201}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":1,"numAtRisk":186},{"groupId":"EG002","numAffected":1,"numAtRisk":201}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":1,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":2,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":1,"numAtRisk":186},{"groupId":"EG002","numAffected":1,"numAtRisk":201}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":186},{"groupId":"EG002","numAffected":1,"numAtRisk":201}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":1,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":1,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":1,"numAtRisk":186},{"groupId":"EG002","numAffected":0,"numAtRisk":201}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":186},{"groupId":"EG002","numAffected":1,"numAtRisk":201}],"term":"Thromboembolic event"}],"timeFrame":"Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization."}