Exact(6)
The core + extension safety set consists of all randomized patients who received ≥1 study drug dose.
Extension safety set was all randomized patients who entered the extension and received ≥1 deferasirox dose during the extension.
Throughout each OL extension, safety was assessed by the incidence of adverse events (AEs) and of withdrawals due to AEs.
Extension intention-to-treat (ITT) (all randomized patients exposed to trial product who entered the extension) and extension safety (all patients exposed to trial product who entered the extension) populations were used for efficacy and safety analyses, respectively.
An analysis of safety during the 26-week extension period consisted of the extension safety analysis set (all patients who entered the extension period, regardless of rescue therapy and received ≥1 dose of extension double-blind study drug).
Study HGKB was an open label extension safety study offered to patients who completed or discontinued from study HGKA, study HGJZ (investigating superiority of OLAI vs. placebo), or study LOBS (investigating product performance and bioavailability of OLAI).
Similar(54)
EXTRA POINTS The Giants are close to agreement on a four-year extension for safety SAM GARNES worth about $8 million.
The proposed techno-economic model for life extension of safety critical elements consists of three phases: preparation, assessment, and implementation.
Contract cheating, by definition and nature, is fundamentally wrong and poses a potential threat to standards in higher education and thus, by extension, public safety.
The aim of this paper is to present a comprehensive literature review and classification framework for academic research and industrial practices related to life extension of safety critical systems and installations.
Life extension of safety critical systems is gaining popularity in many industries due to the increasing demand in world's energy consumption and the strong desire to reduce carbon emissions by different countries.
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