Statistical analysis
death
DISEASE, SECONDARY
Based on mortality rates in the DisCoVeRy [No formal interim analysis for efficacy was planned. Safety assessment by an independent Data Monitoring Committee (DMC) was planned after prespecified number of enrolled participants. Due to external evidence provided by the RECOVERY trial [Efficacy and safety analyses were performed on the modified intent to treat analysis set, consisting of all randomised participants who received at least one dose of study drug. A sensitivity analysis was performed by censoring post-discontinuation or post-rescue observations for participants who discontinued the study intervention and/or received rescue treatment (tocilizumab or increased dose of systemic corticosteroids).We analysed the primary endpoint with the Cochran–Mantel–Haenszel test stratified by country/group of neighbouring countries, as the sample size did not allow use of the stratification factors of randomisation (centres and disease severity). For comparison with prior baricitinib trials, a post hoc analysis of death up to day-28 was performed, using the same approach. Kaplan–Meier curves up to day 61 (60 days after inclusion) were plotted.Additional information of analysis of secondary endpoints including safety are available in the Additional file 