| Document Date: 2015-05-01 11:57:22
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Company Single-Agent TARCEVA Group / Placebo Group / OSI Pharmaceuticals LLC / / IndustryTerm healthcare / food / treatment of NSCLC and pancreatic cancer / / MedicalCondition Hepatic Impairment Hepatic failure / primary liver cancer / Chest pain / Headache / myopathy / dyspnea and decreased appetite / progressive unexplained pulmonary symptoms / Mucosal inflammation / dermatitis / Cerebrovascular accident / cerebral hemorrhage / nausea / Stomatitis / Thrombocytopenia / gastroduodenal ulcers / hepatic metastases / colitis / Stevens-Johnson syndrome / syncope / Conjunctivitis / fatigue / metastatic non-small cell lung cancer / cerebrovascular accidents / persistent severe diarrhea / gastritis / significant liver tumor / rash pruritic / disorder / Non-Small Cell Lung Cancer / hematemesis / diarrhea / exfoliative rash / severe acute renal failure / Microangiopathic Hemolytic Anemia / Pruritus / exfoliative skin disorders / Infections / hepatorenal syndrome / Back pain / palmar-plantar erythrodysaesthesia syndrome / diverticular disease / skin hyperpigmentation / pancreatic cancer / NCI-CTC Grade MedDRA Preferred Term Rash / NSCLC whose disease / Paronychia / severe dehydration / NSCLC whose tumors / tumor / keratoconjunctivitis sicca / keratitis / hematochezia / peptic ulcer / hemolytic anemia / pigmentation disorder / cancer / bullous and exfoliative skin disorders / acne / Renal Failure Hepatorenal syndrome / tumors / disease / Arthralgia / NSCLC / dyspnea / thrombocytopenia / myocardial infarction/ischemia / ependymoma / Carcinogenesis / Stevens-Johnson syndrome/Toxic epidermal necrolysis / Diarrhea N / deep venous thrombosis / rash erythematous / rash pruritic / folliculitis / Pancreatic Cancer TARCEVA / progressive disease / eczema / monotherapy lung cancer / skin ulcer / ileus / erythema / pancreatic carcinoma / fever / rhabdomyolysis / melena / vomiting / pain / renal insufficiency / metastatic pancreatic cancer / Myocardial infarction / severe rash / hepatic failure / urticaria / pancreatitis / eye pain / Ocular Disorders / fatal hepatic failure / Infection / rapidly progressing liver failure / Renal Failure / cough / inflammation / persistent severe keratitis / Depression / metastases / rash / MedDRA Preferred Term Rash / pulmonary symptoms / Interstitial Lung Disease / furuncle / uveitis / dehydration / / MedicalTreatment chemotherapy / chemotherapies / statin therapy / contraception / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position investigator / Counsel / / Product carboplatin / cisplatin / itraconazole / ranitidine / carbamazepine / clarithromycin / omeprazole / rifampin / phenytoin / etoposide / TAO / ketoconazole / ciprofloxacin / TARCEVA / / Technology Pharmacokinetics / chemotherapy / / URL www.fda.gov/medwatch / http /
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Microsoft Word - 14A002-TAR-WPI.doc