{"eventGroups":[{"description":"Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).","id":"EG000","otherNumAffected":58,"otherNumAtRisk":58,"seriousNumAffected":17,"seriousNumAtRisk":58,"title":"Cisplatin + Radiation, Then Surgery"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":58}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":58}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":58}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":58}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":58}],"term":"Otherhematologic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58}],"term":"Lymphatics"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":58}],"term":"Cardiovascular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Hearing"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":58}],"term":"Endocrine"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Ocular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":58}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":58}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":58}],"term":"Diarrhea Without Colostomy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":58}],"term":"Other Gastrointestinal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":58}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":58}],"term":"Other Constitutional"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":58}],"term":"Pain Rt"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":58}],"term":"Other Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":58}],"term":"Hepatic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":58}],"term":"Allergy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58}],"term":"Febrile With Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":58}],"term":"Other Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":58}],"term":"Metabolic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":58}],"term":"Musculoskeletal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58}],"term":"Neuropathy Motor"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":58}],"term":"Neuropathy Sensor"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":58}],"term":"Otherneurologic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":58}],"term":"Creatinine"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":58}],"term":"Other Genitourinary/Renal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Vaginal Dryness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Other Sexual/Reproductive"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":58}],"term":"Pulmonary"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":58}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":58}],"term":"Radiation Dermatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":58}],"term":"Rash Desquamation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Wound Not-Infectious"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":58}],"term":"Other Dermatologic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":58}],"term":"Hemorrhage"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58}],"term":"Thrombosis Embolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Ischemia/Cardiac Infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Diarrhea Without Colostomy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Febrile With Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Infection Without Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Infection Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Hypercalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Hyperkalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Confusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58}],"term":"Wound Infectious"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Skin Other"}],"timeFrame":"SAE (Serious Adverse Events): All adverse events occurring during study chemo radiation treatment period and up to 30 days after stopping the study treatment are reported without regard to attribution. Up to eleven weeks from the start of study treatment. OAE(Other Adverse Events): All treatment-related adverse events occurring during study chemo radiation treatment period and up to 30 days after stopping the study treatment are reported. Up to eleven weeks from the start of study treatment."}