GVHD characteristics at baseline
| Characteristic . | MMF (n = 74) . | Placebo (n = 77) . |
|---|---|---|
| Onset type, n (%) | ||
| De novo | 29 (39) | 30 (39) |
| Quiescent | 38 (51) | 38 (49) |
| Progressive | 7 (9) | 9 (12) |
| Karnofsky score, n (%) | ||
| 100 | 11 (15) | 16 (21) |
| 80-90 | 48 (65) | 44 (57) |
| 60-70 | 15 (20) | 14 (18) |
| < 60 | 0 (0) | 3 (4) |
| Platelet count < 100 000/μL, n (%) | 17 (23) | 17 (22) |
| Bilirubin > 2 mg/dL, n (%) | 4 (5) | 5 (6) |
| Skin severity, n (%)* | ||
| None | 24 (32) | 11 (14) |
| Mild | 10 (14) | 28 (36) |
| Moderate | 25 (34) | 25 (32) |
| Severe | 15 (20) | 13 (17) |
| Mouth, n (%) | ||
| None | 8 (11) | 20 (26) |
| Mild | 56 (76) | 49 (64) |
| Moderate | 9 (12) | 7 (9) |
| Severe | 1 (1) | 1 (1) |
| Eyes, n (%) | ||
| None | 40 (54) | 41 (53) |
| Mild | 17 (23) | 22 (29) |
| Moderate | 17 (23) | 14 (18) |
| Severe | 0 (0) | 0 (0) |
| Gastrointestinal tract, n (%) | ||
| None | 46 (62) | 49 (64) |
| Mild | 23 (31) | 25 (32) |
| Moderate | 0 (0) | 2 (3) |
| Severe | 5 (7) | 1 (1) |
| Liver, n (%) | ||
| None | 39 (53) | 34 (44) |
| Mild | 22 (30) | 27 (35) |
| Moderate | 10 (14) | 15 (19) |
| Severe | 3 (4) | 1 (1) |
| Joints/fascia, n (%) | ||
| None | 62 (84) | 64 (83) |
| Mild | 7 (9) | 13 (17) |
| Moderate | 5 (7) | 0 (0) |
| Severe | 0 (0) | 0 (0) |
| Female genital tract, n (%)† | ||
| None | 27 (82) | 29 (78) |
| Mild | 2 (6) | 7 (19) |
| Moderate | 4 (12) | 1 (3) |
| Severe | 0 (0) | 0 (0) |
| Eosinophilia, n (%) | 18 (24) | 17 (22) |
| Myositis, n (%) | 2 (3) | 4 (5) |
| Esophageal stricture, n (%) | 1 (1) | 0 (0) |
| No. of involved sites, n (%) | ||
| 1 | 4 (5) | 5 (6) |
| 2 | 18 (24) | 15 (19) |
| 3 | 16 (22) | 19 (25) |
| 4 | 20 (27) | 19 (25) |
| 5-7 | 16 (22) | 19 (25) |
| Overall severity according to NIH algorithm, n (%)* | ||
| Mild | 7 (9) | 9 (12) |
| Moderate | 60 (81) | 65 (84) |
| Severe | 7 (9) | 3 (4) |
| Initial treatment of chronic GVHD, n (%) | ||
| Prednisone | 70 (95) | 73 (95) |
| Cyclosporine | 22 (30) | 23 (30) |
| Tacrolimus | 39 (53) | 39 (51) |
| Sirolimus | 1 (1) | 1 (1) |
| Characteristic . | MMF (n = 74) . | Placebo (n = 77) . |
|---|---|---|
| Onset type, n (%) | ||
| De novo | 29 (39) | 30 (39) |
| Quiescent | 38 (51) | 38 (49) |
| Progressive | 7 (9) | 9 (12) |
| Karnofsky score, n (%) | ||
| 100 | 11 (15) | 16 (21) |
| 80-90 | 48 (65) | 44 (57) |
| 60-70 | 15 (20) | 14 (18) |
| < 60 | 0 (0) | 3 (4) |
| Platelet count < 100 000/μL, n (%) | 17 (23) | 17 (22) |
| Bilirubin > 2 mg/dL, n (%) | 4 (5) | 5 (6) |
| Skin severity, n (%)* | ||
| None | 24 (32) | 11 (14) |
| Mild | 10 (14) | 28 (36) |
| Moderate | 25 (34) | 25 (32) |
| Severe | 15 (20) | 13 (17) |
| Mouth, n (%) | ||
| None | 8 (11) | 20 (26) |
| Mild | 56 (76) | 49 (64) |
| Moderate | 9 (12) | 7 (9) |
| Severe | 1 (1) | 1 (1) |
| Eyes, n (%) | ||
| None | 40 (54) | 41 (53) |
| Mild | 17 (23) | 22 (29) |
| Moderate | 17 (23) | 14 (18) |
| Severe | 0 (0) | 0 (0) |
| Gastrointestinal tract, n (%) | ||
| None | 46 (62) | 49 (64) |
| Mild | 23 (31) | 25 (32) |
| Moderate | 0 (0) | 2 (3) |
| Severe | 5 (7) | 1 (1) |
| Liver, n (%) | ||
| None | 39 (53) | 34 (44) |
| Mild | 22 (30) | 27 (35) |
| Moderate | 10 (14) | 15 (19) |
| Severe | 3 (4) | 1 (1) |
| Joints/fascia, n (%) | ||
| None | 62 (84) | 64 (83) |
| Mild | 7 (9) | 13 (17) |
| Moderate | 5 (7) | 0 (0) |
| Severe | 0 (0) | 0 (0) |
| Female genital tract, n (%)† | ||
| None | 27 (82) | 29 (78) |
| Mild | 2 (6) | 7 (19) |
| Moderate | 4 (12) | 1 (3) |
| Severe | 0 (0) | 0 (0) |
| Eosinophilia, n (%) | 18 (24) | 17 (22) |
| Myositis, n (%) | 2 (3) | 4 (5) |
| Esophageal stricture, n (%) | 1 (1) | 0 (0) |
| No. of involved sites, n (%) | ||
| 1 | 4 (5) | 5 (6) |
| 2 | 18 (24) | 15 (19) |
| 3 | 16 (22) | 19 (25) |
| 4 | 20 (27) | 19 (25) |
| 5-7 | 16 (22) | 19 (25) |
| Overall severity according to NIH algorithm, n (%)* | ||
| Mild | 7 (9) | 9 (12) |
| Moderate | 60 (81) | 65 (84) |
| Severe | 7 (9) | 3 (4) |
| Initial treatment of chronic GVHD, n (%) | ||
| Prednisone | 70 (95) | 73 (95) |
| Cyclosporine | 22 (30) | 23 (30) |
| Tacrolimus | 39 (53) | 39 (51) |
| Sirolimus | 1 (1) | 1 (1) |