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. 2022 Nov 17;2022(11):CD014963. doi: 10.1002/14651858.CD014963.pub2

Risk of bias for analysis 9.4 Serious adverse events.

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
Maskin 2021 Low risk of bias No issues with randomisation. Some concerns Minor issues with appropriate analysis but no relevant number of deviations or exclusions from analysis. High risk of bias Missing adjustment for competing risk of death in a trial with relevant death rate. Low risk of bias No issues with measurement. Low risk of bias No relevant issues with reporting High risk of bias High risk of bias due to missing adjustment for competing risk of death in domain 3.
Munch 2021b Low risk of bias No issues with randomisation process. Low risk of bias No issues with deviations from intended interventions High risk of bias Few, balanced, and blinded exclusions for similar reasons in both arms. Missing adjustment for competing risk of death. Low risk of bias No issues with measurement Low risk of bias No extraordinary issues with potential selection. High risk of bias High risk of bias due to missing adjustment for competing risk of death.