Table 4

GVHD-related outcomes

EndpointMMF
Placebo
HR (95% CI)*P
No. of eventsCumulative incidence at 2 yNo. of eventsCumulative 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 0.09 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 
EndpointMMF
Placebo
HR (95% CI)*P
No. of eventsCumulative incidence at 2 yNo. of eventsCumulative 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 0.09 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.

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