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The primary endpoint of a clinical trial is the endpoint for which the trial is powered. Secondary endpoints are additional endpoints, preferably also pre-specified, ...
An outcome measure, endpoint, effect measure or measure of effect is a measure within medical practice or research, (primarily clinical trials) which is used to assess the effect, both positive and negative, of an intervention or treatment. [1] [2] Measures can often be quantified using effect sizes. [3]
Only patients with measurable disease at baseline should be included in protocols where objective tumor response is the primary endpoint. Measurable disease – the presence of at least one measurable lesion. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology.
The ADVANCE-2 Phase 3 trial did not demonstrate statistical significance for the primary endpoint in delaying the time to relapse of agitation from baseline to Week 5, with reductions of 13.8 and ...
The trial met its primary endpoint, with data demonstrating a statistically significant improvement in the overall response rate in patients treated with the mRNA immunotherapy candidate BNT111 in ...
Bayer's (BAYRY) investigational candidate, finerenone, meets primary endpoint in the phase III FIDELIO_DKD study in patients with CKD and T2D.
A surrogate endpoint of a clinical trial is a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that measures directly how a patient feels, functions or survives. Changes induced by a therapy on a surrogate endpoint are expected to reflect changes in a clinically meaningful endpoint. [8]
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