{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":2,"description":"Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4\n\nGenistein: Estrogen-like compound (isoflavone) derived from soybeans\n\nPlacebo: Pill that contains no medicine","id":"EG000","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":1,"seriousNumAtRisk":2,"title":"Arm A: Genistein Followed by Placebo - GENISTEIN Cycles"},{"deathsNumAffected":1,"deathsNumAtRisk":2,"description":"Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4\n\nGenistein: Estrogen-like compound (isoflavone) derived from soybeans\n\nPlacebo: Pill that contains no medicine","id":"EG001","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":1,"seriousNumAtRisk":2,"title":"Arm B: Placebo Followed by Genistein - GENISTEIN Cycles"},{"deathsNumAffected":0,"deathsNumAtRisk":2,"description":"Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4\n\nGenistein: Estrogen-like compound (isoflavone) derived from soybeans\n\nPlacebo: Pill that contains no medicine","id":"EG002","otherNumAffected":0,"otherNumAtRisk":2,"seriousNumAffected":1,"seriousNumAtRisk":2,"title":"Arm A: Genistein Followed by Placebo - PLACEBO Cycles"},{"deathsNumAffected":0,"deathsNumAtRisk":2,"description":"Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4\n\nGenistein: Estrogen-like compound (isoflavone) derived from soybeans\n\nPlacebo: Pill that contains no medicine","id":"EG003","otherNumAffected":0,"otherNumAtRisk":2,"seriousNumAffected":1,"seriousNumAtRisk":2,"title":"Arm B: Placebo Followed by Genistein - PLACEBO Cycles"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":2,"numEvents":2},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Anal mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":4},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2,"numEvents":9},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":9},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Peripheral sensory Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":4},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Prolonged QTC interval"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Sore throat"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Bladder infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Methemoglobinemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Eye infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAtRisk":2},{"groupId":"EG003","numAtRisk":2}],"term":"Upper respiratory infection"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"febrile neutropenia"}],"timeFrame":"All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention."}