Randomization population1 | On-treatment population2 | |||||||
---|---|---|---|---|---|---|---|---|
MMF group3 | Control group4 | Group I5 | Group II6 | |||||
Patients under MMF 2g/day |
Mean MMF dose/day |
Patients under MMF treatment |
Mean MMF dose/day |
Patients under MMF 2 g/day |
Mean MMF dose/day | Patients under MMF treatment |
Mean MMF dose/day |
|
M30 | 36 (75.0%) | 1844 ± 295 mg | 2 (9.0%) | 125 ± 448 mg | 36 (64.3%) | 1549 ± 741 mg | 3 (21.4%) | 321 ± 668 mg |
M48 | 31 (70.5%) | 1773 ± 424 mg | 6 (33.4%) | 500 ± 786 mg | 33 (66.0%) | 1650 ± 600 mg | 3 (25.0%) | 375 ± 711 mg |
M60 | 26 (60.5%) | 1628 ± 608 mg | 9 (47.4%) | 711 ± 822 mg | 29 (59.2%) | 1704 ± 432 mg | 0 | — |
1Patients randomized to receive either MMF or CsA treatment in the initial study phase.
2Determined by the treatment patients received at the end of the post-trial phase (mycophenolic acid derivative or not).
3Patients who received 2 g MMF per day and 50% of the initial CsA dose.
4Patients who received the usual CsA dose
5Patients who received a treatment with a mycophenolic acid derivative at the end of the follow up phase.
6Patients without a mycophenolic acid derivative at the end of the follow up phase.