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. 2022 Jun 17;2022(6):CD014945. doi: 10.1002/14651858.CD014945.pub2

Risk of bias for analysis 2.6 Serious adverse events within 6 months.

Study Bias
Randomisation process Deviations from intended interventions Missing outcome data Measurement of the outcome Selection of the reported results Overall
Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement
Isa 2021 Some concerns Participants were probably allocated randomly to either the casirivimab/imdevimab group or placebo group, but there were no further information given on the randomization process. There is no information on the allocation concealment. There are no baseline differences that would suggest a problem with randomisation. Low risk of bias Both participants and those delivering the intervention were probably unaware of the assigned intervention received, and the analysis was appropriate. Low risk of bias Data for this outcome was available for all treated participants (casirivimab/imdevimab: 729 participants, placebo = 240 participants). Low risk of bias The measurement of the outcome was appropriate, and it is unlikely that it differed between intervention groups. The outcome assessors were probably unaware of the intervention received. Some concerns There was a trial register entry, which provided details of the pre‐specified outcomes, but serious adverse events was not pre‐specified at trial registration. Some concerns For this outcome, there is a low risk of bias from deviations from intended interventions, missing outcomes and measurement of the outcome. However, there are some concerns for bias due to randomisation process and selection of reported results.