Table 5.
Adverse events
| q1m (n=82) | q2m (n=81) | P value | |||
|---|---|---|---|---|---|
| subjects | events | subjects | events | ||
| Patient deaths, n (%) | 2 (2) | 2 | 0 (0) | 0 | - |
| Graft losses*, n (%) | 0 (0) | 0 | 0 (0) | 0 | - |
| Serious adverse events, n (%) | 10 (12) | 14 | 9 (11) | 10 | 0.40 |
| Infectious | 6 (7) | 8 | 5 (6) | 6 | 0.60 |
| Non-infectious | 4 (5) | 6 | 4 (5) | 4 | 0.53 |
| Adverse events, n (%) | 27 (33) | 34 | 23 (28) | 37 | 0.59 |
| Infectious | 24 (29) | 30 | 19 (23) | 27 | 0.67 |
| Urinary tract | 4 (5) | 5 | 5 (6) | 9 | - |
| Respiratory tract | 15 (18) | 17 | 8 (10) | 9 | - |
| Other infection | 6 (7) | 8 | 8 (10) | 9 | - |
| Malignancy | 1 (1) | 1 | 4 (5) | 5 | 0.09 |
| Skin cancer (nm) | 1 (1) | 1 | 4 (5) | 5 | - |
| Other cancer | 0 (0) | 0 | 0 () | 0 | - |
| Other | 3 (4) | 3 | 4 (5) | 5 | - |
*
, death-censored; nm, non-melanoma