{"eventGroups":[{"description":"Observation (+/- Radiation). Patients receive radiotherapy\\* within 6 months after surgery.\n\nradiation therapy: Given within 6 months after surgery","id":"EG000","otherNumAffected":0,"otherNumAtRisk":77,"seriousNumAffected":0,"seriousNumAtRisk":77,"title":"Arm I"},{"description":"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.\n\nchemotherapy: Given within 10 weeks after surgery.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":85,"seriousNumAffected":12,"seriousNumAtRisk":85,"title":"Arm II"}],"frequencyThreshold":"0","seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":85,"numEvents":3}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1}],"term":"Left ventricular dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1}],"term":"Pulmonary/upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1}],"term":"Gastrointestinal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Neutropenia with symptoms of generalized musculoskeletal pain and fatigue","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":85,"numEvents":2}],"term":"Cardiac ischemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1}],"term":"Motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1}],"term":"Endometrial mucosa thinkening"}],"timeFrame":"From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)"}