1. Assessment of harm in non‐randomised controlled studies.
Study | Participants | Study groups | PTLD | Infection | CMV | Other adverse events |
Barlow 2001 | 63 | Muromonab‐CD3: 38 ATG: 25 |
Not reported | No difference between groups | No difference between groups | Not reported |
Borro 2005 | 28 | Daclizumab: 15 Control: 13 |
Not observed |
Fungal Daclizumab: 1 (7%) Control: 2 (15%) Bacterial Daclizumab: 4 (27%) Control: 2 (15%) |
Daclizumab: 4 (27%) Control: 5 (38%) |
Not observed |
Burton 2006 | 335 | ATG: 151 Daclizumab: 151 |
ATG: 8 (5%) Daclizumab: 2 (1%) |
Not reported | No difference between groups | Not reported |
Garrity 2001 | 61 | Daclizumab: 27 Control: 34 |
Daclizumab: 1 (4%) Control: 1 (3%) |
Fungal Daclizumab: 5 (19%) Control: 5 (15%) |
Daclizumab: 5 (19%) Control: 8 (24%) |
Not reported |
Hachem 2005 | 157 | ATG: 75 Basiliximab: 82 |
ATG: 0.53 cases/100 patient‐years Basiliximab: 3 cases/100 patient‐years |
Not reported |
CMV‐viraemia ATG: 15.1 episodes/100 patient‐months Basiliximab: 15.6 episodes/100 patient‐months |
Not reported |
Lischke 2007 | 25 | ATG: 12 Daclizumab: 13 |
No PTLD | ATG: 10 (83%) Daclizumab: 6 (46%) |
No difference between groups | Thrombocytopenia ATG: 9 (75%) Daclizumab: 0 (0%) |
Marom 2001 | 86 | Daclizumab: 43 Control: 43 |
Not observed | Not reported | Not reported | Not reported |
van Loenhout 2010 | 40 | Alemtuzumab: 20 Control: 20 |
Not reported | No difference between groups | Not reported | Not observed |
ATG ‐ antithymocyte globulin; CMV ‐ cytomegalovirus; PTLD ‐ post‐transplant lymphoproliferative disease