{"description":"A patient who was registered and signed consent but did not initiate treatment is included as at risk for SAE but not at risk for other AEs. This patient never received treatment on study. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.","eventGroups":[{"deathsNumAffected":11,"deathsNumAtRisk":24,"description":"Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity.\n\nNivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks.\n\nIpilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes).\n\nOn days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab.\n\nPatients will be assessed for response every 12 weeks (±7 days).","id":"EG000","otherNumAffected":24,"otherNumAtRisk":24,"seriousNumAffected":16,"seriousNumAtRisk":25,"title":"Nivolumab + Ipilimumab"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":24}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":24}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Allergic rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Amnesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":24}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Anisocoria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":24}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":24}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"bilateral temporal bulging"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":24}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Cachexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Chest wall pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Chronic erythematous rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":24}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":24}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":24}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Dermatitis radiation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"desquamation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Diaphoresis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":24}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":24}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Edema face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"edema of c-spine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Epigastric burning"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"erythema in throat"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":24}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Fibrinogen decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Flu like symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Gastroesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Gastroparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":24}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Hearing impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Hypercalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":24}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":24}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":24}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":24}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":24}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":24}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":24}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Hypophonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":24}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"INR increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Joint range of motion decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Left facial droop"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Left facial paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":24}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Muscle weakness lower limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Muscle weakness right-sided"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":24}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Numbness/ pain forearm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Numbness/ tingling of the arm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":24}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Postnasal drip"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":24}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":24}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Respiratory, thoracic and mediastinal disorders - NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Rhinorrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Right arm pain/ weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Right hand atrophy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Right lower eyelid stye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Sensation of Thick Tongue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Serum amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Sore throat"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":24}],"term":"Trismus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Tumor pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"Urinary frequency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Urine output decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Visual changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":24}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":24}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":24}],"term":"Wheezing"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"The patient also experienced tumor pain at the time of this event.","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Spinal fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"The patient also experienced increased blood bilirubin and cholecystitis at the time of this event.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"The patient also experienced an increase in Aspartate aminotransferase at the time of this event.","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"The patient also experienced constipation at the time of this event.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"One patient also experienced nausea and diarrhea at the time of this event.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"The patient also experienced acute kidney injury and alkalosis at the time of this event.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"The patient also experienced muscle weakness in the right lower limb at the time of this event.","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Pain Right Lower Limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"The patient also experienced anorexia at the time of this event.","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25}],"term":"Adrenal Insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Adenoid Cystic Carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"The patient also experienced hypotension at the time of this event.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Port Malfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"The patient also experienced a respiratory infection (possible pneumonia) at the time of this event.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Viral Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Cognitive Disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Non-Cardiac Chest Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"The patient also experienced fatigue and pain in the chest wall at the time of this event.","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"The patient also experienced non-cardiac chest pain at the time of this event.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"The patient also experienced non-cardiac chest pain, dyspnea, anorexia, and respiratory failure at the time of this event.","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"One patient also experienced abdominal pain at the time of this event. One patient also experienced pericardial effusion and sepsis at the time of this event. One patient also experienced pain at the time of this event.","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25}],"term":"Disease Progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"One patient also experienced left jaw cellulitis at the time of this event.","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"Left Jaw Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25}],"term":"seizure"}],"timeFrame":"Adverse Events (AEs) were collected over a 3 year period, and is still continuing (2 patients still on treatment). For other AEs, each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. For Serious AEs, each patient was followed at time of consent and 100 days post last treatment. 1 Cycle = 84 days/12 weeks and the range of cycles attempted was 1-11."}