Table 2.
Summary of reasons for premature withdrawal from treatment (intention-to-treat population)
| Parameter | MMF (n = 185; n [%]) | IVC (n = 185; n [%]) |
|---|---|---|
| Completed 24-wk open-label induction phase | 150 (81.1) | 156 (84.3) |
| Total no. of patients withdrawn prematurely | 35 (18.9) | 29 (15.7) |
| Reasons for withdrawal from induction phase | ||
| adverse event | 21 (60.0) | 12 (41.4) |
| deterioration with respect to serum creatinine after 12 and 16 wk of treatment | 0 (0.0) | 2 (6.9) |
| dosage reduction of MMF <2 g/d for >14 d | 1 (2.9) | 0 (0.0) |
| lost to follow-up | 1 (2.9) | 2 (6.9) |
| patient died | 3 (8.6) | 1 (3.4) |
| patient withdrew consent | 6 (17.1) | 5 (17.2) |
| physician decision | 1 (2.9) | 3 (10.3) |
| sponsor decision | 2 (5.7) | 1 (3.4) |
| noncompliance | 0 (0.0) | 1 (3.4) |
| reason not noted | 0 (0.0) | 2 (6.9) |