Transcription of Clinical information guide - lenvima.com
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Clinical information guide - lenvima.com
FOR RAI-REFRACTORY DTC. Clinical information guide Indication LENVIMA (lenvatinib) is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC). Important Safety information Warnings and Precautions Hypertension was reported in 73% of patients on LENVIMA vs 16%. with placebo (44% vs 4% grade 3). Blood pressure should be controlled prior to treatment and monitored throughout. Withhold dose for grade 3 hypertension despite optimal antihypertensive therapy; resume at reduced dose when controlled at grade 2. Discontinue for life-threatening hypertension Please see Important Safety information throughout and accompanying full Prescribing information . The SELECT Trial A phase 3, multicenter, randomized, double-blind, placebo-controlled trial in patients with locally recurrent or metastatic RAI-refractory DTC1. RANDOMIZATION.
Patients with locally recurrent or metastatic RAI-refractory DTC (N=392) All patients must have had radiographic evidence of disease progression within 12 months prior
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