Incidence and timing of serious adverse events* occurring in 2 or more patients
| . | D1 to <NE (N = 59) n (%) . | NE to M12 (N = 53) n (%) . | >M12 to M24 (N = 34) n (%) . | >M24 to M48 (N = 29) n (%) . | D1 to M24 (N = 59) n (%) . | D1 to M48 (N = 59) n (%) . |
|---|---|---|---|---|---|---|
| Nervous system disorders | ||||||
| Neurological decompensation | 2 (3.4) | 5 (9.4) | 0 | 0 | 6 (10.2) | 6 (10.2) |
| Aphasia | 0 | 1 (1.9) | 0 | 1 (3.4) | 1 (1.7) | 2 (3.4) |
| Seizure | 0 | 1 (1.9) | 1 (2.9) | 0 | 2 (3.4) | 2 (3.4) |
| Infections and infestations | ||||||
| Device-related infection | 0 | 4 (7.5) | 0 | 0 | 4 (6.8) | 4 (6.8) |
| BK virus infection | 0 | 3 (5.7) | 0 | 0 | 3 (5.1) | 3 (5.1) |
| Bacteremia | 1 (1.7) | 2 (3.8 | 0 | 0 | 3 (5.1) | 3 (5.1) |
| Staphylococcal infection | 0 | 3 (5.7) | 0 | 0 | 3 (5.1) | 3 (5.1) |
| Clostridium difficile infection | 0 | 2 (3.8) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Epstein-Barr viremia | 0 | 2 (3.8) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Human herpesvirus 6 infection | 1 (1.7) | 1 (1.9) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Lung infection | 1 (1.7) | 1 (1.9) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Sepsis | 0 | 2 (3.8) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Septic shock | 0 | 1 (1.9) | 0 | 1 (3.4) | 1 (1.7) | 2 (3.4) |
| General disorders and administration site conditions | ||||||
| Pyrexia | 0 | 3 (5.7) | 0 | 0 | 3 (5.1) | 3 (5.1) |
| Disease progression | 0 | 2 (3.8) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Ear and labyrinth disorders | ||||||
| Hypoacusis | 0 | 2 (3.8) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Gastrointestinal disorders | ||||||
| Diarrhea | 0 | 2 (3.8) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Immune system disorders | ||||||
| Anaphylactic reaction | 1 (1.7) | 0 | 0 | 1 (3.4) | 1 (1.7) | 2 (3.4) |
| Metabolism and nutrition disorders | ||||||
| Feeding intolerance | 0 | 0 | 2 (5.9) | 0 | 2 (3.4) | 2 (3.4) |
| Renal and urinary disorders | ||||||
| Acute kidney injury | 0 | 1 (1.9) | 1 (2.9) | 0 | 2 (3.4) | 2 (3.4) |
| Respiratory, thoracic, and mediastinal disorders | ||||||
| Hemothorax | 0 | 1 (1.9) | 1 (2.9) | 0 | 2 (3.4) | 2 (3.4) |
| Respiratory failure | 0 | 2 (3.8) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Vascular disorders | ||||||
| Hypertension | 1 (1.7) | 1 (1.9) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| . | D1 to <NE (N = 59) n (%) . | NE to M12 (N = 53) n (%) . | >M12 to M24 (N = 34) n (%) . | >M24 to M48 (N = 29) n (%) . | D1 to M24 (N = 59) n (%) . | D1 to M48 (N = 59) n (%) . |
|---|---|---|---|---|---|---|
| Nervous system disorders | ||||||
| Neurological decompensation | 2 (3.4) | 5 (9.4) | 0 | 0 | 6 (10.2) | 6 (10.2) |
| Aphasia | 0 | 1 (1.9) | 0 | 1 (3.4) | 1 (1.7) | 2 (3.4) |
| Seizure | 0 | 1 (1.9) | 1 (2.9) | 0 | 2 (3.4) | 2 (3.4) |
| Infections and infestations | ||||||
| Device-related infection | 0 | 4 (7.5) | 0 | 0 | 4 (6.8) | 4 (6.8) |
| BK virus infection | 0 | 3 (5.7) | 0 | 0 | 3 (5.1) | 3 (5.1) |
| Bacteremia | 1 (1.7) | 2 (3.8 | 0 | 0 | 3 (5.1) | 3 (5.1) |
| Staphylococcal infection | 0 | 3 (5.7) | 0 | 0 | 3 (5.1) | 3 (5.1) |
| Clostridium difficile infection | 0 | 2 (3.8) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Epstein-Barr viremia | 0 | 2 (3.8) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Human herpesvirus 6 infection | 1 (1.7) | 1 (1.9) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Lung infection | 1 (1.7) | 1 (1.9) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Sepsis | 0 | 2 (3.8) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Septic shock | 0 | 1 (1.9) | 0 | 1 (3.4) | 1 (1.7) | 2 (3.4) |
| General disorders and administration site conditions | ||||||
| Pyrexia | 0 | 3 (5.7) | 0 | 0 | 3 (5.1) | 3 (5.1) |
| Disease progression | 0 | 2 (3.8) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Ear and labyrinth disorders | ||||||
| Hypoacusis | 0 | 2 (3.8) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Gastrointestinal disorders | ||||||
| Diarrhea | 0 | 2 (3.8) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Immune system disorders | ||||||
| Anaphylactic reaction | 1 (1.7) | 0 | 0 | 1 (3.4) | 1 (1.7) | 2 (3.4) |
| Metabolism and nutrition disorders | ||||||
| Feeding intolerance | 0 | 0 | 2 (5.9) | 0 | 2 (3.4) | 2 (3.4) |
| Renal and urinary disorders | ||||||
| Acute kidney injury | 0 | 1 (1.9) | 1 (2.9) | 0 | 2 (3.4) | 2 (3.4) |
| Respiratory, thoracic, and mediastinal disorders | ||||||
| Hemothorax | 0 | 1 (1.9) | 1 (2.9) | 0 | 2 (3.4) | 2 (3.4) |
| Respiratory failure | 0 | 2 (3.8) | 0 | 0 | 2 (3.4) | 2 (3.4) |
| Vascular disorders | ||||||
| Hypertension | 1 (1.7) | 1 (1.9) | 0 | 0 | 2 (3.4) | 2 (3.4) |
D, day 1; M, month; NE, neutrophil engraftment.
Does not include severe adverse events of hematologic events, death, or engraftment failure.