Table 2.

Adverse events risk of bias assessment methods

Criterion	Assessment	Explanation
Patient-reported symptoms
Was monitoring active or passive?	Active Passive Unclear	We classified monitoring as 'active' when authors reviewed participants at set timepoints and enquired about symptoms.
Was blinding for participants and outcome assessors adequate?	Adequate Inadequate Unclear	We classified blinding as 'adequate' when both participants and outcome assessors were blinded to the intervention group, and the methods of blinding (including use of a placebo) were described.
Was outcome data reporting complete or incomplete?	Complete Incomplete Unclear	We classified outcome data reporting as 'complete' when data was presented for all the time-points where it was collected.
Were all participants included in reporting?		We report the percentage of randomized participants included in adverse event reporting.
Was theanalysis independent of study sponsor?	Yes No Unclear	We classified the analysis of trials sponsored by pharmaceutical companies as independent of the sponsor when it was clearly stated that the sponsor had no input to the trial analysis
Laboratory tests
Number of tests undertaken	—	We extracted the type and number of laboratory tests were taken.
Timing of tests Was number and timing of tests adequate?	Adequate Inadequate	We classified the number and timing of tests as 'adequate', when tests were taken at baseline, plus two other timepoints within the first week after treatment, plus the last day of the study. We classed the number of test taken as "inadequate", if either the laboratory controls in the first week or controls at four weeks were not performed.
Reporting of test results Was reporting of test results complete?	Complete Incomplete	We classified reporting as 'complete' when test results of all time points were reported. For the trials with inadequate number of tests taken, we considered completeness of reporting as inconsequential, and therefore did not record a judgement.
Independence of data analysis Was data analysis independent?	Yes No Unclear	We classified the analysis of trials sponsored by pharmaceutical companies as independent of the sponsor when it was clearly stated that the sponsor had no input to the trial analysis