Table 3.
Patient incidence of adverse events of interest by category
| Blinatumomab (9‐28 μg/day) | ||
|---|---|---|
|
Phase 1b N = 5 |
Phase 2 N = 21 |
|
| Adverse events of interest, n (%) | 5 (100) | 21 (100) |
| Central nervous system eventsa | 3 (60) | 9 (43) |
| Grade ≥3 | 0 (0) | 1 (5) |
| Cytokine release syndromes | 4 (80) | 8 (38) |
| Grade ≥3 | 0 (0) | 1 (5) |
| Cytopenias | 3 (60) | 19 (91) |
| Grade ≥3 | 3 (60) | 17 (81) |
| Decreased immunoglobulins | 2 (40) | 6 (29) |
| Grade ≥3 | 0 (0) | 0 (0) |
| Elevated liver enzymes | 1 (20) | 6 (29) |
| Grade ≥3 | 0 (0) | 2 (10) |
| Infections | 4 (80) | 15 (71) |
| Grade ≥3 | 2 (40) | 8 (38) |
| Infusion reactions considering durationb | 5 (100) | 15 (71) |
| Grade ≥3 | 0 (0) | 2 (10) |
| Lymphopenia | 1 (20) | 5 (24) |
| Grade ≥3 | 1 (20) | 5 (24) |
| Neurologic events | 3 (60) | 9 (43) |
| Grade ≥3 | 0 (0) | 1 (5) |
| Neutropenia | 3 (60) | 17 (81) |
| Grade ≥3 | 3 (60) | 16 (76) |
| Thromboembolic events | 0 (0) | 7 (33)c |
| Grade ≥3 | 0 (0) | 0 (0) |
| Tumor lysis syndrome | 0 (0) | 1 (5) |
| Grade ≥3 | 0 (0) | 1 (5) |
a
Phase 1b included headache, somnolence and lethargy; phase 2 included headache, insomnia, tremor, aphasia, disorientation, dizziness postural, dysgeusia, extrapyramidal disorder, hypophagia, intention tremor, neuralgia and presyncope.
b
Potential infusion‐related toxicities were identified using a narrow search strategy for infusion reactions with an onset within 48 h of infusion start and no restriction in duration.
c
All grade 2 events: 1 case of grade 2 deep vein thrombosis and 6 cases of grade 2 disseminated intravascular coagulation.