13. ROB table: sarilumab vs standard care(SC). Incidence of serious adverse events.
| Study | 1.Randomisation | 2.Deviations from intervention | 3.Missing outcome data | 4.Measurement of the outcome | 5.Selection of the reported results | Overall risk of bias |
| Gordon REMAP‐CAP 2021 | Low | Some concerns 1 | Low | Some concerns 2 | Low | Some concerns |
| Lescure 2021 | Low | Low | Low | Low | Low | Low |
1 Quote: “open‐label” Comment: unblinded study. Deviations from intended intervention arising because of the study context: No participant cross‐over. Administration of co‐interventions of interest: antivirals (Remdesivir, 32.8%) and corticosteroids (> 80%) were administered, but numbers per group were not reported. Hence, this domain was rated as some concern as not enough information on deviations that arose because of the trial context were reported. Participants were analysed according to their randomised groups for the outcome. Of note, 3 vs 10 participants were excluded from the analysis post‐randomisation for reasons related to missing data. This method was considered appropriate to estimate the effect of assignment to intervention.
2 Comment: method of measuring outcome probably appropriate. Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor). Assessment of this outcome requires clinical judgement and can be influenced by knowledge of the intervention assignment, but is not likely in the context of the pandemic.