Table 3:
Safety Results from E1910 Consolidation Cycles
| Adverse Reaction * | Blinatumomab + Chemotherapy N=111 | Chemotherapy N=112 | Risk Difference (%) |
|---|---|---|---|
| N (%) | N (%) | ||
| All Grade with Risk Difference ≥ 10% | |||
| Tremor | 25 (23) | 3 (3) | 20 |
| Musculoskeletal pain | 25 (23) | 6 (5) | 17 |
| Cytokine release syndrome | 18 (16) | 0 | 16 |
| Diarrhoea | 32 (29) | 17 (15) | 14 |
| Infection | 39 (35) | 25 (22) | 13 |
| Headache | 46 (41) | 33 (30) | 12 |
| Nausea | 36 (32) | 25 (22) | 10 |
| Pyrexia | 17 (15) | 6 (5) | 10 |
| Aphasia | 11 (10) | 0 | 10 |
| Leukopenia | 48 (43) | 64 (57) | −14 |
| Grade ≥ 3 with Risk Difference ≥ 5% | |||
| Infection | 34 (31) | 23 (21) | 10 |
| Aphasia | 9 (8) | 0 | 8 |
| Hypertension | 11 (10) | 3 (3) | 7 |
| Lymphopenia | 33 (30) | 26 (23) | 7 |
| Febrile neutropenia | 21 (19) | 28 (25) | −6 |
| Anaemia | 32 (29) | 43 (38) | −11 |
| Neutropenia | 85 (77) | 100 (89) | −13 |
| Thrombocytopenia | 63 (57) | 79 (71) | −14 |
| Leukopenia | 45 (41) | 63 (56) | −16 |
Source: FDA Analysis
*
Includes Grouped Terms (see Supplementary Table S5)