PASSReviewer 1· 95% conf
The trial design is rigorous with clear randomization, blinding, power analysis, and pre-specified inclusion/exclusion criteria.
Evidence
paraphrase[Methods, Trial Design and Treatments]
“Within each cohort, patients were randomly assigned in a 2:1 ratio to receive cabozantinib or placebo. Randomization was stratified by concurrent somatostatin analogue use and primary tumor site...”direct quote[Methods, Trial Design and Treatments]
“Patients continued blinded treatment until disease progression, unacceptable toxicity, or withdrawal of consent.”paraphrase[Methods, Statistical Analysis]
“The trial was designed with targeted sample sizes of 210 and 185 patients in the epNET and pNET cohorts, respectively, to provide 90% power using stratified one-sided log-rank tests to detect true hazard ratios of 0.583 and 0.568...”PASSReviewer 2· 95% conf
The trial design is rigorous: randomized, double-blinded, placebo-controlled, with a pre-specified sample size, stratification, and a clear primary endpoint assessed by blinded independent central review.
Evidence
paraphrase[Methods, Trial Design and Treatments]
“Within each cohort, patients were randomly assigned in a 2:1 ratio to receive cabozantinib or placebo. Randomization was stratified by concurrent somatostatin analogue use and primary tumor site ...”direct quote[Methods, Trial Design and Treatments]
“Patients continued blinded treatment until disease progression, unacceptable toxicity, or withdrawal of consent.”paraphrase[Methods, Statistical Analysis]
“The trial was designed with targeted sample sizes of 210 and 185 patients in the epNET and pNET cohorts, respectively, to provide 90% power using stratified one-sided log-rank tests to detect true hazard ratios of 0.583 and 0.568 ...”