{"description":"SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.","eventGroups":[{"description":"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.\n\npaclitaxel: Given IV dosage 135 mg/m2/dose\n\ncarboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \\[(0.93 x GFR mL/min/m2) + 15\\]= 6.5 x \\[(0.93 x GFR mL/min/m2) + 15\\]. (BSA = body surface area in square meters). GFR is reported in institutions as \"uncorrected\" or \"raw\" (not normalized to BSA) or \"corrected.\" This number needs to be converted to GFR in mL/min/m2.\n\nifosfamide: Given IV dosage 1800 mg/m2/dose\n\nfilgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2\n\nlaboratory biomarker analysis: Optional correlative studies","id":"EG000","otherNumAffected":18,"otherNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"title":"Treatment (Chemotherapy, Biological Therapy)"}],"frequencyThreshold":"0","otherEvents":[{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Agitation"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Alanine aminotransferase increased"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":20}],"term":"Anemia"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Aspartate aminotransferase increased"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Ataxia"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Bladder infection"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Blood and lymphatic system disorders - Other"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Cardiac disorders - Other"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Confusion"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20}],"term":"Febrile neutropenia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hyperglycemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Hypokalemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Hyponatremia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hypophosphatemia"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hypotension"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20}],"term":"Infections and infestations - Other"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Intracranial hemorrhage"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20}],"term":"Lymphocyte count decreased"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Nail loss"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Nervous system disorders - Other"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":20}],"term":"Neutrophil count decreased"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Oral hemorrhage"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":20}],"term":"Platelet count decreased"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Vomiting"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":20}],"term":"White blood cell decreased"}]}