Table 4:
Safety Results from 20120215 Consolidation Cycle
| Adverse Reaction * | Blinatumomab N=54 | Chemotherapy N=52 | Risk Difference (%) |
|---|---|---|---|
| N (%) | N (%) | ||
| All Grade with Risk Difference ≥ 10% | |||
| Pyrexia | 41 (76) | 10 (19) | 57 |
| Headache | 20 (37) | 8 (15) | 22 |
| Hypogammaglobulinemia | 13 (24) | 6 (12) | 12 |
| Rash | 12 (22) | 6 (12) | 12 |
| Nausea | 23 (43) | 16 (31) | 12 |
| Abdominal pain | 7 (13) | 12 (23) | −10 |
| Hemorrhage | 6 (11) | 12 (23) | −12 |
| Infection | 7 (13) | 15 (29) | −16 |
| Neutropenia | 10 (19) | 18 (35) | −16 |
| Liver function test abnormal | 5 (9) | 14 (27) | −20 |
| Musculoskeletal pain | 5 (9) | 15 (29) | −20 |
| Anemia | 13 (24) | 24 (46) | −22 |
| Febrile neutropenia | 1 (2) | 13 (25) | −23 |
| Thrombocytopenia | 8 (15) | 20 (39) | −24 |
| Stomatitis | 6 (11) | 31 (60) | −49 |
| Grade ≥ 3 with Risk Difference ≥ 5% | |||
| Pyrexia | 3 (6) | 0 | 6 |
| Aplasia | 0 | 4 (8) | −8 |
| Liver function test abnormal | 3 (6) | 9 (17) | −13 |
| Neutropenia | 9 (17) | 16 (31) | −14 |
| Thrombocytopenia | 8 (15) | 18 (35) | −20 |
| Febrile neutropenia | 1 (2) | 13 (25) | −23 |
| Stomatitis | 2 (4) | 15 (29) | −25 |
| Anaemia | 8 (15) | 22 (42) | −27 |
Source: FDA Analysis
*
Assessed from the start of study therapy through 30 days from the end of the assigned treatment cycle, or until the start of the allo-HSCT preparative regimen, whichever occurred first.
Includes Grouped Terms (see Supplementary Table S5).