Table 5.
AEs by Diagnostic Criteria
| VOD/SOS Diagnosed by: | ||||
|---|---|---|---|---|
| n (%) | All VOD/SOS Criteria (N = 803) | Baltimore Criteria (n = 449) | Modified Seattle Criteria (n = 331) | Biopsy (n = 23) |
| Treatment-emergent AEs | 565 (70) | 333 (74) | 215 (65) | 17 (74) |
| Most common (>5% in all patients) | ||||
| Multiorgan failure | 87 (11) | 62 (14) | 23 (7) | 2 (9) |
| Hypotension | 86 (11) | 55 (12) | 28 (8) | 3 (13) |
| Respiratory failure | 67 (8) | 38 (8) | 27 (8) | 2 (9) |
| Diarrhea | 55 (7) | 29 (6) | 23 (7) | 3 (13) |
| Veno-occlusive liver disease* | 53 (7) | 40 (9) | 8 (2) | 5 (22) |
| Pulmonary hemorrhage | 51 (6) | 34 (8) | 17 (5) | 0 |
| Pyrexia | 49 (6) | 29 (6) | 19 (6) | 1 (4) |
| Vomiting | 44 (5) | 16 (4) | 23 (7) | 5 (22) |
| Renal failure | 41 (5) | 25 (6) | 15 (5) | 1 (4) |
| Serious AEs | 421 (52) | 273 (61) | 135 (41) | 13 (57) |
| Treatment-related AEs | 167 (21) | 90 (20) | 74 (22) | 3 (13) |
| Leading to discontinuation | 100 (12) | 58 (13) | 41 (12) | 1 (4) |
| Leading to death | 23 (3) | 16 (4) | 7 (2) | 0 |
| Hemorrhage | 229 (29) | 139 (31) | 83 (25) | 7 (30) |
| Hypotension | 87 (11) | 56 (12) | 28 (8) | 3 (13) |
*
AEs were reported by investigators; by definition, all patients had veno-occlusive liver disease.