| Document Date: 2011-05-20 15:59:20
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City Reference / / Company Pfizer Inc. / Alteon Inc. / / Event FDA Phase / Product Issues / / Facility Laboratory Tests CBCs / Laboratory Abnormalities Reported / Laboratory Tests ADVERSE REACTIONS / / IndustryTerm treatment of gastrointestinal stromal tumor after disease / food / / MedicalCondition rash / hand-foot syndrome / normal and cardiac failure / syndrome Neurology Altered taste / Chest Pain / pulmonary hemorrhage / headache / Left Ventricular Dysfunction / cardiac failure / liver failure / pNET / Any Gastrointestinal Diarrhea / cerebrovascular accident / Hemorrhoids / nausea / stomatitis / Alopecia / hyperthyroidism / metastatic disease / transient ischemic attack / severe infection / Torsade de Pointes / fatigue / unstable angina / metastatic non-small cell lung cancer / encephalopathy / bradycardia / pulmonary embolism / diarrhea / cardiac arrest / renal cell carcinoma / Glossodynia / illness / constipation / Thyroid Dysfunction / Pruritus / Gastrointestinal Disorders / back pain / Influenza / reflux esophagitis / adrenal insufficiency / pancreatic neuroendocrine tumors / Study A. Tumor / abdominal pain / tumor / Epistaxis / congestive heart failure / Gastrointestinal Stromal Tumor / necrosis / liver metastases / Hypertension / mucositis/stomatitis / ventricular dysfunction / cardiomyopathy / brain hemorrhages / severe and life-threatening hemoptysis / disease / arthralgia / NSCLC / dyspnea / hypothyroidism / Treatment-emergent acquired hypothyroidism / stromal tumor / Chills / pulmonary tumors / Carcinogenesis / malignant hypertension / Reversible Posterior Leukoencephalopathy Syndrome / Erythema / fever / mucositis / myocardial disorders / pain / vomiting / Advanced Pancreatic Neuroendocrine Tumors / GERD / myocardial infarction / Any Constitutional Fatigue / heart failure / Fatal pulmonary hemorrhage / cardiac disease / Dizziness / renal failure / cough / inflammation / hand-foot syndrome / Advanced Renal Cell Carcinoma / Cardiac Hypertension / Rash / / MedicalTreatment surgery / bypass / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Product ACTH / rifampin / ketoconazole / SUTENT / wound healing / / Technology MRI / Pharmacokinetics / / URL www.fda.gov/medwatch / /
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SUTENT (sunitinib) capsules