Table 2. Characteristics of VOD at Baseline (Treated Population) among All Patients and by Treatment Arm.
| Characteristic | Arm A (n = 75) | Arm B (n = 74) | All Patients (n = 149) |
|---|---|---|---|
| Days since total bilirubin ≥2 mg/dL, median (range)* | 6 (−10 to 40) | 4.5 (1-30) | 5 (−10 to 40) |
| Total bilirubin, mg/dL, median (range) | 6.4 (0.5-52.5) | 6.3 (0.9-30.1) | 6.4 (0.5-52.5) |
| Days since VOD diagnosis, median (range)* | 2 (1-30) | 2 (1-26) | 2 (1-30) |
| Signs and symptoms, n (%) | |||
| Jaundice | 70 (93) | 73 (99) | 143 (96) |
| Ascites | 54 (72) | 55 (74) | 109 (73) |
| >5% weight gain | 60 (80) | 55 (74) | 115 (77) |
| RUQ pain | 53 (71) | 47 (64) | 100 (67) |
| Hepatomegaly | 56 (75) | 49 (66) | 105 (70) |
| Underwent liver biopsy, n (%) | 16 (21) | 10 (14) | 26 (17) |
| WHVPG on liver biopsy, mm Hg, median (range) | 23 (10-43) | 18.5 (11-27) | 23 (10-43) |
| SGOT/AST at hospital admission, U/L, median (range) | 28 (8–233) | 24 (9–836) | 26 (8-836) |
| AST elevation at hospital admission, n (%) | 17 (23) | 14 (19) | 31 (21) |
| SGPT/ALT at hospital admission, U/L, median (range) | 26 (6-432) | 28 (5-383) | 27 (5-432) |
| Creatinine, mg/dL, median (range) | 1.7 (0.2-5.0) | 1.5 (0.2-5.5) | 1.6 (0.2-5.5) |
| Abnormal creatinine, n (%) | 53 (71) | 48 (65) | 101 (68) |
| Abnormal portal flow, n (%) | 38 (51) | 29 (39) | 67 (45) |
| Requiring oxygen, n (%) | 41 (55) | 51 (69) | 92 (62) |
| Ventilator-dependent, n (%) | 6 (8) | 4 (5) | 10 (7) |
| Receiving dialysis, n (%) | 3 (4) | 4 (5) | 7 (5) |
| Encephalopathy, n (%) | 18 (24) | 11 (15) | 29 (19) |
| Organ systems compromised, n (%) | |||
| 1 | 1 (1) | 2 (3) | 3 (2) |
| 2 | 37 (49) | 39 (53) | 76 (51) |
| 3 | 34 (45) | 30 (41) | 64 (43) |
| 4 | 3 (4) | 3 (4) | 6 (4) |
AST indicates aspartate aminotransferase; RUQ, right upper quadrant; SGOT/AST, aspartate aminotransferase; SGPT/ALT, alanine aminotransferase; WHVPG, wedged transhepatic venous pressure gradient.
*
At randomization. Negative values represent patients who did not have total bilirubin ≥2 mg/dL until after randomization (VOD diagnosed by liver biopsy rather than based on clinical criteria).