Aoki 2012.

Study characteristics
Methods	Study design: RCT Settings: NR Study period: January 2006 to January 2011 Trial/protocol registration and availability: not available
Participants	Inclusion criteria: active UC, refractory to corticosteroids Exclusion criteria: NR Disease activity: NR Disease duration: NR Extent of disease: NR Age: mean: IG: 41.4 (SD 15.7) years; CG: 34.7 (SD 13.9) years Sex (M/F): IG: 23/10; CG: 40/40 Concurrent therapies: NR Number randomised: IG: 33; CG: 80 Number reaching end of study: 113
Interventions	IG: tacrolimus 0.05–0.15 mg/kg bodyweight/day, IV CG: ciclosporin 2 mg/kg bodyweight/day, IV
Outcomes	Length of intervention and follow‐up points: 14 days of remission induction therapy, followed up for 12 months Primary outcomes Definition of remission or clinical improvement by study authors: participants who achieved a CAI score ≥ 3 were considered to have achieved remission. A decrease in CAI by ≥ 4 points was considered clinical improvement Number of participants who achieved remission: IG: 15; CG: 24 Number of participants who achieved clinical improvement: IG: 23; CG: 62 Secondary outcomes Number of participants who required other rescue medication: NR Number of participants who underwent surgery: NR Adverse events: NR Withdrawal due to adverse events: NR Serious adverse events: NR Time to adverse events from beginning of study: NR
Notes	Author contact details: no details found Conflict of interest: NR Sponsor: NR
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	RCT but randomisation method not specified.
Allocation concealment (selection bias)	Unclear risk	No information provided.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information provided. Likely high as tacrolimus was provided orally and ciclosporin IV.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information provided.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants reached end of study.
Selective reporting (reporting bias)	Low risk	Authors stated outcomes in their methods were reflected in their results.
Other bias	High risk	Major differences in numbers randomised between groups. Also, the ratio of M:F in the CG was 1:1 (40 M and 40 F); however, in the IG, the ratio was about 2:1 (23 M and 10 F).