Adverse events by treatment arm
| 1-year AE . | Inolimomab, n (%) (n = 49) . | Usual care, n (%) (n = 51) . |
|---|---|---|
| At least one serious AE | 47 (96) | 46 (90) |
| At least one grade 3, 4, or 5 AE | 49 (100) | 50 (98) |
| At least one AE related to treatment | 7 (14) | 21 (41) |
| At least one AE resulting in treatment discontinuation | 7 (14) | 2 (4) |
| At least one AE resulting in death | 26 (53) | 30 (59) |
| At least one viral infection | 38 (78) | 47 (92) |
| CMV reactivation | 21 (42.9) | 17 (33.3) |
| EBV reactivation | 24 (49.0) | 27 (52.9) |
| Other viral infection | 22 (44.9) | 34 (66.7) |
| At least one bacterial infection | 40 (82) | 43 (84) |
| At least one fungal infection | 17 (35) | 19 (37) |
| At least one parasitic infection | 3 (6) | 4 (8) |
| Sepsis | 7 (14) | 12 (24) |
| Septic shock | 2 (4) | 8 (16) |
| 1-year AE . | Inolimomab, n (%) (n = 49) . | Usual care, n (%) (n = 51) . |
|---|---|---|
| At least one serious AE | 47 (96) | 46 (90) |
| At least one grade 3, 4, or 5 AE | 49 (100) | 50 (98) |
| At least one AE related to treatment | 7 (14) | 21 (41) |
| At least one AE resulting in treatment discontinuation | 7 (14) | 2 (4) |
| At least one AE resulting in death | 26 (53) | 30 (59) |
| At least one viral infection | 38 (78) | 47 (92) |
| CMV reactivation | 21 (42.9) | 17 (33.3) |
| EBV reactivation | 24 (49.0) | 27 (52.9) |
| Other viral infection | 22 (44.9) | 34 (66.7) |
| At least one bacterial infection | 40 (82) | 43 (84) |
| At least one fungal infection | 17 (35) | 19 (37) |
| At least one parasitic infection | 3 (6) | 4 (8) |
| Sepsis | 7 (14) | 12 (24) |
| Septic shock | 2 (4) | 8 (16) |
AE, adverse event; CMV, cytomegalovirus; EBV, Epstein-Barr virus.