Patients with treatment-emergent adverse EOIs of grade ≥3 among those entering the blinatumomab maintenance phase (N = 36)
| EOI category . | Induction (cycles 1 to 2), n (%) . | Consolidation (cycles 3 to 5), n (%) . | Maintenance (cycles ≥6), n (%) . |
|---|---|---|---|
| Any adverse EOI | 35 (97.2) | 31 (86.1) | 26 (72.2) |
| Event leading to treatment discontinuation | 0 (0) | 0 (0) | 2 (5.6) |
| Serious adverse event | 11 (30.6) | 11 (30.6) | 13 (36.1) |
| Fatal adverse event | 0 (0) | 0 (0) | 1 (2.8) |
| Any adverse event of grade ≥3 | 30 (83.3) | 19 (52.8) | 14 (38.9) |
| Grade ≥3 adverse EOIs reported in at least 3% of patients | |||
| Central neuropsychiatric events due to direct neurotoxicities | 4 (11.1) | 0 (0) | 4 (11.1)* |
| CRS | 2 (5.6) | 0 (0) | 1 (2.8)† |
| Cytopenia | 22 (61.1) | 12 (33.3) | 6 (16.7) |
| Decreased immunoglobulins | 3 (8.3) | 1 (2.8) | 2 (5.6) |
| Infections | 6 (16.7) | 8 (22.2) | 8 (22.2)‡ |
| Lymphopenia | 0 (0) | 1 (2.8) | 2 (5.6) |
| Neutropenia | 16 (44.4) | 12 (33.3) | 2 (5.6) |
| Elevated liver enzyme | 5 (13.9) | 1 (2.8) | 1 (2.8) |
| Infusion reaction considering duration | 3 (8.3) | 0 (0) | 0 (0) |
| EOI category . | Induction (cycles 1 to 2), n (%) . | Consolidation (cycles 3 to 5), n (%) . | Maintenance (cycles ≥6), n (%) . |
|---|---|---|---|
| Any adverse EOI | 35 (97.2) | 31 (86.1) | 26 (72.2) |
| Event leading to treatment discontinuation | 0 (0) | 0 (0) | 2 (5.6) |
| Serious adverse event | 11 (30.6) | 11 (30.6) | 13 (36.1) |
| Fatal adverse event | 0 (0) | 0 (0) | 1 (2.8) |
| Any adverse event of grade ≥3 | 30 (83.3) | 19 (52.8) | 14 (38.9) |
| Grade ≥3 adverse EOIs reported in at least 3% of patients | |||
| Central neuropsychiatric events due to direct neurotoxicities | 4 (11.1) | 0 (0) | 4 (11.1)* |
| CRS | 2 (5.6) | 0 (0) | 1 (2.8)† |
| Cytopenia | 22 (61.1) | 12 (33.3) | 6 (16.7) |
| Decreased immunoglobulins | 3 (8.3) | 1 (2.8) | 2 (5.6) |
| Infections | 6 (16.7) | 8 (22.2) | 8 (22.2)‡ |
| Lymphopenia | 0 (0) | 1 (2.8) | 2 (5.6) |
| Neutropenia | 16 (44.4) | 12 (33.3) | 2 (5.6) |
| Elevated liver enzyme | 5 (13.9) | 1 (2.8) | 1 (2.8) |
| Infusion reaction considering duration | 3 (8.3) | 0 (0) | 0 (0) |
Ataxia (n = 1), progressive multifocal leukoencephalopathy (n = 1), sensory loss (n = 1), somnolence (n = 1).
Grade 3 macrophage activation syndrome in cycle 6, while in MRD + CR.
Device-related infection (n = 2), Clostridium difficile (n = 1), mastoiditis (n = 1), sepsis (n = 1), pneumonia (n = 1), upper respiratory tract infection (n = 1), urinary tract infection (n = 1), varicella zoster infection (n = 1).