{"eventGroups":[{"description":"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.\n\nOn day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.\n\nDepending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy.","id":"EG000","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":2,"seriousNumAtRisk":4,"title":"Chemotherapy/Radiation/Surgery"}],"frequencyThreshold":"5","otherEvents":[{"organSystem":"Ear and labyrinth disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Tinnitus"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Hemoglobin"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":2}],"term":"Neutrophils/granulocytes"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":3}],"term":"Fatigue"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":2}],"term":"Insomnia"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Weight loss"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Dermatology/Skin - Other"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":4,"numEvents":3}],"term":"Hair loss/alopecia (scalp or body)"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Rash/desquamation"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":4,"numEvents":4}],"term":"Rash: dermatitis associated with radiation"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":2}],"term":"Skin breakdown/decubitus ulcer"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":4,"numEvents":5}],"term":"Anorexia"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":3}],"term":"Constipation"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":4,"numEvents":4}],"term":"Dehydration"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":2}],"term":"Diarrhea"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":2}],"term":"Dry mouth/salivary gland (xerostomia)"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":4,"numEvents":8}],"term":"Dysphagia (difficulty swallowing)"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Esophagitis"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Heartburn/dyspepsia"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":4,"numEvents":9}],"term":"Mucositis/stomatitis (clinical exam), Oral Cavity"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":4,"numEvents":7}],"term":"Mucositis/stomatitis (clinical exam), Pharynx"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":5}],"term":"Mucositis/stomatitis (functional/symptomatic), Oral Cavity"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":2}],"term":"Mucositis/stomatitis (functional/symptomatic), Pharynx"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":4,"numEvents":4}],"term":"Nausea"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Vomiting"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Colitis, infectious (e.g., Clostridium difficile)"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Febrile neutropenia"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Skin Infection with Grade 3 or 4 neutrophils"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils (Foreign Body)"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Infection (Upper Aerodigestive, NOS)"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Infection (Upper Airway, NOS)"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Infection with unknown ANC (Upper Aerodigestive)"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":2}],"term":"Muscle weakness, Extremity-lower"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":3}],"term":"Muscle weakness, Whole body/generalized"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Confusion"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":2}],"term":"Mood alteration"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":2}],"term":"Ocular/Visual - Other (Specify)"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Back Pain"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":2}],"term":"Chest Pain"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":2}],"term":"Head Pain"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Oral Pain"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":4,"numEvents":5}],"term":"Throat Pain"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":3}],"term":"Aspiration"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Fistula, pulmonary/upper respiratory"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Pulmonary/Upper Respiratory - Other (Specify)"},{"organSystem":"Reproductive system and breast disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Sexual/Reproductive Function - Other (Specify)"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":4,"numEvents":3}],"term":"Rash: acne/acneiform"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":4}],"term":"Hyperglycemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":2}],"term":"Hypocalcemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Hypokalemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Hypophosphatemia"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":3}],"term":"Leukopenia"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":4,"numEvents":12}],"term":"Lymphopenia"}],"seriousEvents":[{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Dehydration"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Diarrhea"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Nausea"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Colitis, Infection"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Febrile Neutropenia"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Infection with Grade 3-4 Neutrophils"}]}