Table 4.
Endpoint | MMF |
Placebo |
HR (95% CI)* | P | ||
---|---|---|---|---|---|---|
No. of events | Cumulative incidence at 2 y | No. of events | Cumulative incidence at 2 y | |||
Treatment success | 11 | 0.23 | 13 | 0.18 | 1.66 (0.7-3.7) | .22 |
Treatment failure | 43 | 0.70 | 38 | 0.64 | 1.65 (1.1-2.6) | .03 |
Secondary systemic treatment† | 24 | 0.38 | 25 | 0.44 | 1.19 (0.7-2.1) | .55 |
Bronchiolitis obliterans† | 5 | 0.09 | 4 | 0.07 | 1.61 (0.4-6.0) | .48 |
Withdrawal of prednisone† | 30 | 0.44 | 33 | 0.41 | 1.28 (0.8-2.1) | .34 |
End of systemic treatment† | 15 | 0.23 | 15 | 0.18 | 1.51 (0.7-3.2) | .28 |
Hazard ratio for MMF arm relative to placebo arm; stratified on the number of sites affected by chronic GVHD at onset (1 vs > 1) and the type of conditioning regimen (myeloablative vs nonmyeloablative).
Competing risks are limited to recurrent malignancy and death.