| Document Date: 2014-05-30 12:43:20
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City NSCLC / Reference / / Company Pfizer Inc. / / Continent Asia / / Event FDA Phase / / Facility These laboratory / Laboratory Abnormalities / / IndustryTerm food / / MedicalCondition Photophobia / muscular weakness / ventricular tachycardia / dysesthesia / lymphoma / nausea / vision disorders / Rhinitis / bradyarrhythmias / peripheral neuropathy / polyneuropathy / syncope / Torsade de pointes / fatigue / pulmonary / metastatic non-small cell lung cancer / hypoesthesia / Bradycardia / renal abscesses / Laryngitis / pulmonary embolism / diarrhea / ILD/pneumonitis / constipation / Pneumonitis / sepsis / hypotension / long QT syndrome / arrhythmia / tumor / congestive heart failure / pneumonia / liver metastases / opportunistic infections / Renal Cysts Renal cysts / tumors / respiratory failure / disease / NSCLC / Nasopharyngitis / dyspnea / acute respiratory distress syndrome / Carcinogenesis / neutropenia / Upper respiratory infection / fever / neuralgia / vomiting / hepatic failure / infection / anaplastic lymphoma kinase / Dizziness / cyst / thrombosis / Diplopia / rash / Pharyngitis / cholestasis / abscess / Interstitial Lung Disease / vision disorder / renal cysts / / MedicalTreatment chemotherapy / intravenous infusion / dialysis / contraceptive methods / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position investigator / General / / Product itraconazole / cyclosporine / alfentanil / clarithromycin / Archos 3 vision Portable Video Player (PVP) / rifampin / phenytoin / digoxin / ketoconazole / fentanyl / XALKORI / / Technology Pharmacokinetics / chemotherapy / Pharmacodynamics / dialysis / / URL www.fda.gov/medwatch / http /
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-----------------------WARNINGS AND PRECAUTIONS----------------------- • Hepatotoxicity: Fatal hepatotoxicity occurred in 0.2% of patients. Monitor with periodic liver testing. Temporarily suspend, dose reduce, or pe