Table 5. Summary of Treatment-Emergent AEs in Patients with Severe Hepatic VOD after HSCT (Treated Population), Overall and by Treatment Arm.
| AE | Arm A (n = 75) |
Arm B (n = 74 |
All Patients (n = 149) |
P (A vs B) |
|---|---|---|---|---|
| Any AE, n (%) | 71 (95) | 73 (99) | 144 (97) | 0.367 |
| Grade 3-4 | 64 (85) | 68 (92) | 132 (89) | 0.303 |
| Grade 5 | 12 (16) | 14 (19) | 26 (17) | 0.671 |
| Most common grade 3-5 AEs, n (%) | ||||
| Renal failure | 19 (25) | 27 (37) | 46 (31) | 0.159 |
| Hypotension | 20 (27) | 23 (31) | 43 (29) | 0.591 |
| Hypoxia | 13 (17) | 25 (34) | 38 (26) | 0.025 |
| Pulmonary–other | 16 (21) | 17 (23) | 33 (22) | 0.846 |
| Treatment-related AEs, n (%) | 5 (7) | 7 (10) | 12 (8) | 0.563 |
| Grade 3-4 | 2 (3) | 3 (4) | 5 (3) | 0.681 |
| Grade 5 | 0 | 0 | 0 | – |
| Treatment-related bleeding events, n (%) | 0 | 1 (1) | 1 (1) | 0.497 |
| Grade 3-4 | 0 | 1 (1) | 1 (1) | 0.497 |
| Grade 5 | 0 | 0 | 0 | – |
| Expected AEs, n (%) | 56 (75) | 64 (87) | 120 (81) | 0.097 |
| Grade 3-4 | 38 (51) | 43 (58) | 81 (54) | 0.412 |
| Grade 5 | 1 (1) | 1 (1) | 2 (1) | 1.000 |
AEs indicate adverse events; VOD, veno-occlusive disease; HSCT, hematopoietic stem cell transplantation.