전문 번역가, 번역 회사, 웹 페이지 및 자유롭게 사용할 수 있는 번역 저장소 등을 활용합니다.
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마지막 업데이트: 2014-10-08
사용 빈도: 1
품질:
omschrijving ter ondersteuning van de risico-voordeelafweging heeft de aanvrager de chmp gegevens over veiligheid en werkzaamheid na 48 weken uit het lopende fase iii-protocol 018 (a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of mk-0518 in combination with an optimized background therapy (obt), versus optimized background therapy alone, in hiv-infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies) en protocol 019 (a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of mk-0518 in combination with an optimized background therapy (obt), versus optimized background therapy alone, in hiv- infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies) ter beoordeling voorgelegd.
description to further support the benefit risk assessment, the mah has provided the chmp with the 48-week safety and efficacy data from the ongoing phase iii protocol 018 (a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of mk-0518 in combination with an optimized background therapy (obt), versus optimized background therapy alone, in hiv- infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies) and protocol 019 (a multicenter, double-blind, randomized, placebo- controlled study to evaluate the safety and antiretroviral activity of mk-0518 in combination with an optimized background therapy (obt), versus optimized background therapy alone, in hiv-infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies) for review.
