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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, ...
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]
Patients were randomized to receive either spironolactone (25 to 50 mg) daily or placebo. Both groups were continued on standard therapy. The primary endpoint was all-cause mortality. Secondary endpoints included hospitalization for heart failure, changes in symptoms of heart failure, and serum potassium levels. [1] [2]
Navacaprant and placebo led to a -12.5 change from baseline on the primary endpoint. Navacaprant showed a decline of 5.8 points on the secondary endpoint versus a decline of 5.5 on the placebo.
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 ...
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]
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 study’s primary endpoint of progression-free survival (PFS) was met at primary analysis, demonstrating pirtobrutinib was superior to the investigator’s choice of idelalisib plus rituximab ...