Cohen 2002.

Methods	Design: open‐label RCT Duration: not reported Follow up: 1 year
Participants	Setting: multicentre study (US Rapamune‐CSA Study Group) Country: USA Kidney transplant recipients; de novo DD or LD transplants Number (group 1/group 2): 309 randomised; 296 (154/142) Mean age ± SD (years): not reported Sex (M/F): not reported Exclusions: African Americans
Interventions	Treatment group 1 (rSRL/sCSA) SRL: levels 5 to 15 ng/mL (doses not reported) CSA: levels 150 to 300 ng/mL (doses not reported) Treatment group 2 (sSRL/rCSA) SRL: levels 10 to 20 ng/mL (doses not reported) CSA: levels 50 to125 ng/mL (doses not reported) Baseline immunosuppression Steroids (prednisone or prednisolone)
Outcomes	Death (all causes) Graft loss censored for death Graft loss or death with a functioning graft Acute rejection Steroid‐resistant rejection CrCl SCr CAN Infection CMV infection Malignancy Haematological adverse effects Biochemical adverse effects Surgical adverse effects Cosmetic/life style adverse effects
Notes	Comparison: variable dose of TOR‐I and CNI Abstracts only available
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information to permit judgement
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Primary outcome unclear
Incomplete outcome data (attrition bias) All outcomes	Low risk	4% participants did not complete 1 year follow‐up
Selective reporting (reporting bias)	Low risk	Expected outcomes reported
Other bias	Unclear risk	Insufficient information to permit judgement