Daclizumab triple 1998.

Methods	Parallel RCT
Participants	International multi centre study: USA (15), Canada (3), Sweden (3) First cadaveric kidney transplant Mean age ± SD Treatment: 47 ± 13 Control: 47 ± 13 Number (treatment/control): 260 (134/126) Sex (M/F) Treatment: 74/52 Control: 81/53
Interventions	Treatment group Daclizumab: Five doses of 1 mg/kg. First dose within 24 h prior to transplant and then at 2, 4, 6 and 8 weeks post‐transplant Control group Placebo: Five doses of 0.2 polysorbate 80/mL. First dose within 24 h prior to transplant and then at 2, 4, 6 and 8 weeks post‐transplant Baseline immunosuppression CSA dose: NS Azathioprine dose: NS Steroid dose: NS
Outcomes	Mortality Graft loss Acute rejection Infection/CMV Delayed graft function Malignancy
Notes	Pooled analysis of Daclizumab double and triple therapy studies published after primary studies. Data used only when presented separately for each study. 3 year follow‐up
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Stated "randomised, double‐blind placebo‐controlled" no further information provided
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding (performance bias and detection bias) Objective outcomes	Unclear risk	Double blind, blinding of outcome assessors not stated
Blinding (performance bias and detection bias) Subjective outcomes	Unclear risk	Double blind, blinding of outcome assessors not stated
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis reported for the primary analyses of efficacy and safety, all patients followed up or accounted for.
Selective reporting (reporting bias)	Low risk	Primary outcomes for this review (death, graft loss and acute rejection) have been reported. No study protocol available to assess secondary outcomes of study
Other bias	High risk	Supported by a grant from Hoffmann‐LaRoche Inc