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Maximum dose of 700 mg","id":"EG000","otherNumAffected":36,"otherNumAtRisk":36,"seriousNumAffected":14,"seriousNumAtRisk":36,"title":"Platinum/Docetaxal + AT-101"},{"deathsNumAffected":1,"deathsNumAtRisk":18,"description":"(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).\n\nDay #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.\n\nDocetaxel: Docetaxel (Taxotere) 75 mg/m2 Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg","id":"EG001","otherNumAffected":18,"otherNumAtRisk":18,"seriousNumAffected":5,"seriousNumAtRisk":18,"title":"Active Comparator Arm"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Abdominal distention"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":18,"numEvents":0}],"term":"Abdominal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Acne"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":36,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":18,"numEvents":5}],"term":"Alkaline phosphatase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Allergic reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":36,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":36,"numEvents":7},{"groupId":"EG001","numAffected":5,"numAtRisk":18,"numEvents":6}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE 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(3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":18,"numEvents":0}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":36,"numEvents":11},{"groupId":"EG001","numAffected":9,"numAtRisk":18,"numEvents":10}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"BUN Increase","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":18,"numEvents":0}],"term":"Constitutional Symptoms - Other (Specify)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"restless leg syndrome","organSystem":"General disorders","sourceVocabulary":"CTCAE 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(3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":36,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":36,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":18,"numEvents":3}],"term":"Depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":18,"numEvents":0}],"term":"Dermal change"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":36,"numEvents":9},{"groupId":"EG001","numAffected":3,"numAtRisk":18,"numEvents":3}],"term":"Dermatitis radiation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"skin changes","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":18,"numEvents":0}],"term":"Dermatology/Skin - Other (Specify)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"cut on the right hand","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":18,"numEvents":0}],"term":"Dermatology/Skin - Other (Specify)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"psoriasis flare up on lower right and left arms","organSystem":"Skin and 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(3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":36,"numEvents":7},{"groupId":"EG001","numAffected":4,"numAtRisk":18,"numEvents":4}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":36,"numEvents":18},{"groupId":"EG001","numAffected":6,"numAtRisk":18,"numEvents":7}],"term":"Dry mouth"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":18,"numEvents":0}],"term":"Dry skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":36,"numEvents":23},{"groupId":"EG001","numAffected":7,"numAtRisk":18,"numEvents":7}],"term":"Dysphagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":36,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":18,"numEvents":5}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":18,"numEvents":0}],"term":"Ear pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":36,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Ear, nose and throat examination abnormal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":36,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Edema limbs"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":36,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":18,"numEvents":0}],"term":"Edema: head and neck"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 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