PASSReviewer 1· 95% conf
Design is rigorous: randomized, double-blind, placebo-controlled with permuted-block randomization, prespecified power calculations, and clear eligibility criteria.
Evidence
direct quote[Methods, Trial treatment]
“Randomization was done using permuted block randomization managed via an interactive web randomization system.”direct quote[Methods, Statistical analysis]
“It was estimated that approximately 692 patients were to be randomized to observe the 261 radiographic progression events or deaths required to provide 91% power to detect a hazard ratio of 0.64 at a two-sided significance level of 0.02475”direct quote[Results, Secondary endpoints]
“Double-blinding prior to radiographic progression has been maintained to allow ongoing follow-up of overall survival.”PASSReviewer 2· 95% conf
The randomized, double-blind, placebo-controlled design is rigorously described with stated randomization method, stratification, power analysis, eligibility criteria, and analysis population.
Evidence
direct quote[Methods, Trial treatment]
“Randomization was done using permuted block randomization managed via an interactive web randomization system.”direct quote[Methods, Statistical analysis]
“It was estimated that approximately 692 patients were to be randomized to observe the 261 radiographic progression events or deaths required to provide 91% power to detect a hazard ratio of 0.64 at a two-sided significance level of 0.02475 for the final analysis (no interim) of radiographic progression-free survival in all patients.”paraphrase[Methods, Participants; Statistical analysis]
“Eligible male patients were aged 18 years or older, had an ECOG performance status score of 0–2 and had at least one deleterious HRR gene alteration on central testing.”PASSReviewer 3· 95% conf
The trial design is rigorous with proper randomization, blinding, and sample size justification.
Evidence
direct quote[Methods]
“Randomization was done using permuted block randomization managed via an interactive web randomization system.”paraphrase[Abstract]
“The double-blind AMPLITUDE trial evaluated combining niraparib... versus placebo and AAP.”paraphrase[Methods]
“It was estimated that approximately 692 patients were to be randomized to observe the 261 radiographic progression events or deaths required to provide 91% power to detect a hazard ratio of 0.64...”