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. 2023 Jan 26;2023(1):CD015167. doi: 10.1002/14651858.CD015167.pub2

Risk of bias for analysis 6.3 Adverse events at any grade.

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
Ali 2021 Low risk of bias Participants were randomized through sequentially numbered opaque sealed envelope simple randomization method in a 4:1 ratio to receive either hIVIG plus SOC or only SOC. The allocation sequence was random and concealed. There are no baseline differences that would suggest a problem with randomisation. Low risk of bias The participants were unaware of their assigned intervention and those delivering the intervention were aware of intervention assigned during the trial, but there were no deviations from intended interventions and the analysis was appropriate. Low risk of bias Data for this outcome was available for all 50 participants randomized. 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 aware of the intervention received, but it is unlikely that knowledge of intervention received would have affected outcome measurement. Low risk of bias The data that produced this result was analysed in accordance with the predefined outcomes stated in the protocol and trial registration. Low risk of bias For the outcome "safety", there is a low risk of bias for all the domains.