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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, for which the trial may not be powered.
The SCoRS is currently being used as a co-primary endpoint in several international phase 2 and phase 3 trials assessing cognitive treatment change in schizophrenia and has been permitted by the FDA for pivotal registration trials.
Roche's (RHHBY) phase III study, evaluating a combination of Tecentriq and Avastin plus carboplatin and paclitaxel for first line treatment of advanced lung cancer met its co-primary endpoint of ...
In the Clarity AD core study (18 months), the mean change from baseline between the once every two weeks lecanemab treated group and the placebo group was -0.45 (P<0.0001) on the primary endpoint of the Clinical Dementia Rating-Sum of Boxes (CDR-SB) global cognitive and functional scale.
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 ...
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 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 ...
Phase II in soft tissue sarcoma shows three-fold increase in tumour hyalinization (trial’s primary endpoint, also associated with survival) compared to historical data from radiotherapy; Phase I trial of IMP761 reported favourable initial safety results advancing the first-in-class agonist LAG-3 antibody program