Table 2.
GVHD characteristics for the group
| N (%) | |||
|---|---|---|---|
| MMF | Placebo | Total | |
| Total enrolled | 116 | 119 | 235 |
| Grade of de novo aGVHD at diagnosis | |||
| Grade I | 11 (9.5) | 16 (13.4) | 27 (11.5) |
| Grade II | 68 (58.6) | 62 (52.1) | 130 (55.3) |
| Grade III | 30 (25.9) | 34 (28.6) | 64 (27.2) |
| Grade IV | 7 (6) | 7 (5.9) | 14 (6) |
| Cutaneous involvement at onset | |||
| No rash | 31 (26.7) | 36 (30.3) | 67 (28.5) |
| Maculopapular rash, <25% of body surface | 11 (9.5) | 14 (11.8) | 25 (10.6) |
| Maculopapular rash, 25%-50% of body surface | 27 (23.3) | 21 (17.6) | 48 (20.4) |
| Generalized erythroderma | 46 (39.7) | 44 (37) | 90 (38.3) |
| Generalized erythroderma with bullae formation and desquamation | 1 (0.9) | 4 (3.4) | 5 (2.1) |
| Upper GI abnormalities at diagnosis | |||
| No protracted nausea and vomiting | 85 (73.3) | 82 (68.9) | 167 (71.1) |
| Persistent nausea, vomiting, or anorexia | 31 (26.7) | 37 (31.1) | 68 (28.9) |
| Lower GI abnormalities at diagnosis | |||
| No diarrhea | 57 (49.1) | 66 (55.5) | 123 (52.3) |
| Diarrhea ≤500 mL/d or <280 mL/m2 | 21 (18.1) | 19 (16) | 40 (17) |
| Diarrhea >500 but ≤1000 mL/d or 280-555 mL/m2 | 21 (18.1) | 14 (11.8) | 35 (14.9) |
| Diarrhea >1000 but ≤1500 mL/d or 556-833 mL/m2 | 8 (6.9) | 9 (7.6) | 17 (7.2) |
| Diarrhea >1500 mL/d or >833 mL/m2 | 7 (6) | 11 (9.2) | 18 (7.7) |
| Severe abdominal pain with or without ileus, or stool with frank blood or melena | 2 (1.7) | 0 (0) | 2 (0.9) |
| Liver abnormalities at diagnosis, bilirubin, mg/dL | |||
| <2 | 106 (91.4) | 110 (92.4) | 216 (91.9) |
| 2-3 | 1 (0.9) | 5 (4.2) | 6 (2.6) |
| 3.1-6 | 6 (5.2) | 4 (3.4) | 10 (4.3) |
| 6.1-15 | 2 (1.7) | 0 (0) | 2 (0.9) |
| >15 | 1 (0.9) | 0 (0) | 1 (0.4) |