PASSReviewer 1· 90% conf
The trial design is rigorous with randomization, stratification, and prespecified analyses; blinding is not applicable due to open-label design, which is stated.
Evidence
direct quote[Methods, Trial design, participants and treatments]
“Participants were randomly assigned in a 1:1 ratio to receive pembrolizumab 200 mg intravenously once every 3 weeks for up to 35 cycles (~2 years) plus axitinib 5 mg by mouth twice daily continuously or sunitinib 50 mg by mouth once daily for 4 weeks on and 2 weeks off, continuously. Randomization was stratified according to the IMDC risk group (favorable versus intermediate versus poor risk) and by geographic region (North America versus Western Europe versus rest of the world).”paraphrase[Methods, Inclusion and ethics]
“KEYNOTE-426 ( NCT02853331 ) is a randomized, open-label, phase 3 trial conducted across 129 medical centers globally.”direct quote[Methods, Statistical analysis]
“Because the trial outcome was previously defined as positive and the present analysis is exploratory, no formal hypothesis testing was performed in the present analysis.”PASSReviewer 2· 90% conf
The trial design is rigorous with clear randomization, stratification, and prespecified analyses; blinding is not applicable due to open-label design, which is stated.
Evidence
direct quote[Methods, Trial design, participants and treatments]
“Participants were randomly assigned in a 1:1 ratio to receive pembrolizumab 200 mg intravenously once every 3 weeks for up to 35 cycles (~2 years) plus axitinib 5 mg by mouth twice daily continuously or sunitinib 50 mg by mouth once daily for 4 weeks on and 2 weeks off, continuously. Randomization was stratified according to the IMDC risk group (favorable versus intermediate versus poor risk) and by geographic region (North America versus Western Europe versus rest of the world).”paraphrase[Methods, Inclusion and ethics]
“KEYNOTE-426 ( NCT02853331 ) is a randomized, open-label, phase 3 trial conducted across 129 medical centers globally.”direct quote[Methods, Statistical analysis]
“Because the trial outcome was previously defined as positive and the present analysis is exploratory, no formal hypothesis testing was performed in the present analysis.”