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[Preprint]. 2021 Mar 2:rs.3.rs-227796. [Version 1] doi: 10.21203/rs.3.rs-227796/v1

Table 1.

Trial outcomes. Definitions for all outcome are provided in the statistical analysis plan available in the Supplementary Materials.

Outcomes Variable Type Approach to Analysis
Efficacy outcomes
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale 14 days after randomization (assessed on Study Day 15) Ordinal Cumulative probability model with logit link
All-location, all-cause 14-day mortality (assessed on Study Day 15) Binary Logistic regression
All-location, all-cause 28-day mortality (assessed on Study Day 29) Binary Logistic regression
Survival through 28 days Time-to-event Proportional hazards regression
Time to hospital discharge through 28 days Time-to-event Multistate model with death as a competing risk
Time to recovery Time-to-event Cumulative probability model with logit link
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3, 8 and 29 Ordinal Cumulative probability model with logit link
Oxygen-free days through Day 28 Ordinal Cumulative probability model with logit link
Ventilator-free days through Day 28 Ordinal Cumulative probability model with logit link
Vasopressor-free days through Day 28 Ordinal Cumulative probability model with logit link
ICU-free days through Day 28 Ordinal Cumulative probability model with logit link
Hospital-free days through Day 28 Ordinal Cumulative probability model with logit link
Safety Outcomes
Receipt of renal replacement therapy Binary Risk difference
Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) Binary Risk difference
Cardiovascular event (myocardial infarction or ischemic stroke) Binary Risk difference
Transfusion reaction Binary Risk difference
Transfusion related acute lung injury (TRALI) Binary Risk difference
Transfusion associated circulatory overload (TACO) Binary Risk difference
Transfusion-related infection Binary Risk difference