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CGRP RO was evaluated in healthy subjects (n=3) at the lowest clinically efficacious dose (140 mg, PO) of telcagepant ~2h after dosing, coinciding with the time point of efficacy evaluation in clinical migraine studies.
This review highlights the evidence supporting symptom control and quality-of-life (QOL) measures as predictors of survival in treatment-refractory metastatic colorectal cancer (mCRC) and describes a composite symptom control and QOL end point recently reported in a Phase III trial that may serve as a more reasonable end point of efficacy in this population.
This superiority trial did not meet its primary end point as well as any other secondary end point of efficacy.
This superiority trial did not meet its primary end point (CR rate in the delayed phase) as well as any other secondary end point of efficacy.
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The co-primary end points of efficacy and pharmacokinetics have been met (Ismael et al, 2012).
CDDP-HAI may have a potential to be a promising alternative treatment option for HCC at advanced stages from the both points of efficacy and toxicity profile.
In the first year of follow-up, largely due to cultural practices to visit traditional healers as the first point of care, the point estimate of efficacy was unreliable: the per protocol vaccine efficacy against severe RVGE was 1%95%5% confidence interval [CI]: −431.7, 81.6); the intention-to-treat vaccine efficacy was 42.9% (95% CI: −125.7, 87.7).
Composite point estimates of efficacy (episodes of incontinence per 24-hour period, frequency, and voided volume) and safety (dry mouth, withdrawal, and dose modification) were calculated.
As reviewed (Clark and Vissel, 2013), a range of studies point to efficacy of anti-TNF agents and GLP-1 mimetics, which, as TNF induces insulin resistance, ameliorate consecutive harmful steps in those brain disease states with excess TNF, whatever their traditional, clinically based, disparate nomenclatures.
Oral rotavirus vaccines have yielded different point estimates of efficacy when tested in different populations.
We review the study design elements of rotavirus vaccine trials that may affect point estimates of efficacy, and propose a framework for evaluating new rotavirus vaccines.
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