PASSReviewer 1· 85% conf
The study design is rigorous, with clear randomization, blinding, power analysis, and prespecified inclusion criteria, though some elements are not fully detailed.
Evidence
paraphrase[Methods, Study design]
“Patients were randomly assigned 1:1:1 to receive pembrolizumab 200 mg intravenously every 3 weeks for ≤35 cycles (~2 years) plus platinum-based chemotherapy...”direct quote[Methods, Outcomes and assessments]
“BOR of complete or partial response was evaluated per RECIST v.1.1 as assessed by blinded independent central review (BICR).”direct quote[Methods, Statistical analysis]
“Before sample selection for this analysis, power calculations were performed to determine the sample size needed to ensure sufficient power for testing associations with clinical outcomes.”PASSReviewer 2· 85% conf
The study design is rigorous, with clear randomization, blinding, power analysis, and prespecified inclusion criteria, though some elements are not fully detailed.
Evidence
paraphrase[Methods, Study design]
“Patients were randomly assigned 1:1:1 to receive pembrolizumab 200 mg intravenously every 3 weeks for ≤35 cycles (~2 years) plus platinum-based chemotherapy...”direct quote[Methods, Outcomes and assessments]
“BOR of complete or partial response was evaluated per RECIST v.1.1 as assessed by blinded independent central review (BICR).”paraphrase[Methods, Statistical analysis]
“Bootstrap sampling of data from preliminary work conducted on trials outside of KEYNOTE-361 across different settings of sample sizes suggested a design targeting 125 patients per arm could achieve 80% power after correcting for multiple testing.”