PASSReviewer 1· 90% conf
The investigational product (cyclophosphamide, cyclosporin, methotrexate) is identified with dosing regimens. Software tools are identified (SAS? not explicitly named but statistical methods are described). No antibodies, cell lines, or organisms are used, so those are not applicable.
Evidence
paraphrase[Methods, Trial procedures]
“The control GVHD prophylaxis consisted of methotrexate (intravenous bolus of 15 mg per meter squared on day 1 and 10 mg per meter squared on days 3, 6 and 11) and cyclosporin... The investigational GVHD prophylaxis consisted of cyclophosphamide (50 mg per kilogram on days 3 and 4 after transplant followed by cyclosporin”absence[Methods, Statistical Analysis]
Statistical software is not explicitly named.PASSReviewer 2· 85% conf
The investigational product (PTCy and cyclosporin) and control (methotrexate and cyclosporin) are adequately identified with dosing details.
Evidence
direct quote[Methods, Trial procedures]
“The control GVHD prophylaxis consisted of methotrexate (intravenous bolus of 15 mg per meter squared on day 1 and 10 mg per meter squared on days 3, 6 and 11) and cyclosporin (dosing and monitoring levels as per institutional practice) starting 1 to 3 days before transplant and tapered not before day 90.”absence[Methods, Statistical Analysis]
Statistical software is not explicitly named.