| Document Date: 2012-11-16 15:17:24
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City Reference / / Company Alteon Inc. / GlaxoSmithKline / / Currency pence / / Event FDA Phase / / IndustryTerm other cancer therapies / imaging / food / Monitor for signs and symptoms / Other Cancer Therapy / / MedicalCondition adipocytic soft tissue sarcoma / altered taste / torsades de pointes / chest pain / headache / active infection / intracranial hemorrhage / chronic use / gastrointestinal stromal tumors / Dysfunction / cerebrovascular accident / nausea / Serious infections / alopecia / hemoptysis / transient ischemic attack / embolus / subarachnoid hemorrhage / fatigue / pulmonary / Cardiac dysfunction / gastrointestinal hemorrhage / skin hypopigmentation / diarrhea / advanced soft tissue sarcoma / Renal Cell Carcinoma / infections / blindness / Gilbert’s syndrome / Proteinuria / tumor / Abdominal pain / epistaxis / congestive heart failure / Hypertension / cancer / disease / dyspnea / Hypothyroidism / hematuria / dysgeusia / Carcinogenesis / neurological disorder / venous thrombosis / Soft Tissue Sarcoma / neutropenia / Reversible Posterior Leukoencephalopathy Syndrome / lethargy / nephrotic syndrome / seizure / dysphonia / vomiting / pain / myocardial infarction / hepatic failure / cardiac disease / clinically significant gastrointestinal hemorrhage / Infection / advanced renal cell carcinoma / fatal pulmonary emboli / rash / syndrome / / MedicalTreatment chemotherapy / surgery / cancer therapies / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position Major / / Product simvastatin / clarithromycin / rifampin / STS / ketoconazole / VOTRIENT / / ProvinceOrState Prince Edward Island / / PublishedMedium Baseline / / Technology Pharmacokinetics / magnetic resonance imaging / chemotherapy / treating cancer / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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Venous thrombotic events (VTE) have been observed, including fatal pulmonary emboli (PE). Monitor for signs and symptoms of VTE and PE. (5.6) Gastrointestinal perforation or fistula has occurred. Fatal perforat