{"description":"The definition of adverse event and/or serious adverse event used to collect adverse event information is the same as clinicaltrials.gov.","eventGroups":[{"deathsNumAffected":3,"deathsNumAtRisk":3,"description":"This is the starting dose of temsirolimus at 7.5 mg/m\\^2 given IV. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8.\n\nTemsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.\n\nEtoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.\n\nCyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.","id":"EG000","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":3,"seriousNumAtRisk":3,"title":"Dose Level 1"},{"deathsNumAffected":1,"deathsNumAtRisk":3,"description":"If Dose Level 1 is tolerated, the study will escalate to Dose Level 2 following the dose escalation schedule. Dose Level 2 will be administered via IV at 10 mg/m\\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8.\n\nTemsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.\n\nEtoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.\n\nCyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.","id":"EG001","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Dose Level 2"},{"deathsNumAffected":3,"deathsNumAtRisk":6,"description":"If Dose Level 2 is tolerated, the study will escalate to Dose Level 3 following the dose escalation schedule. Dose Level 3 will be administered via IV at 15 mg/m\\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8.\n\nTemsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.\n\nEtoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.\n\nCyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.","id":"EG002","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":3,"seriousNumAtRisk":6,"title":"Dose Level 3"},{"deathsNumAffected":2,"deathsNumAtRisk":3,"description":"If Dose Level 3 is tolerated, the study will escalate to Dose Level 4 following the dose escalation schedule. Dose Level 4 will be administered via IV at 25 mg/m\\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus will not be escalated beyond Dose Level 4.\n\nTemsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.\n\nEtoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.\n\nCyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.","id":"EG003","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Dose Level 4"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":6,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Alkalosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Anal fissure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Anal mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Anal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":6,"numEvents":5},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":2}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":6,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Bicarbonate serum low"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Buttock pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Cholesterol high"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Decreased respiratory rate"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Diaper rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":6,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Dystonic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 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