Table 3. Number of Patients Experiencing Adverse Eventsa.
| No. of patients (%) | ||
|---|---|---|
| Blinatumomab (n = 54) | Consolidation chemotherapy (n = 51) | |
| Any adverse event (including serious adverse events) | 54 (100.0) | 49 (96.1) |
| Any serious adverse eventb | 13 (24.1) | 22 (43.1) |
| Adverse event leading to discontinuation of trial treatment | 2 (3.7) | 0 |
| Grade ≥3 adverse event | 31 (57.4) | 42 (82.4) |
| Grade ≥3 adverse events in ≥3% of patients in either group | 31 (57.4) | 42 (82.4) |
| Thrombocytopeniac | 10 (18.5) | 18 (35.3) |
| Stomatitisd | 10 (18.5) | 16 (31.4) |
| Neutropeniae | 9 (16.7) | 16 (31.4) |
| Anemia | 8 (14.8) | 21 (41.2) |
| Leukopeniaf | 4 (7.4) | 4 (7.8) |
| Pyrexia | 3 (5.6) | 0 |
| Elevated liver enzyme levelsg | 3 (5.6) | 9 (17.6) |
| Aplasia | 2 (3.7) | 4 (7.8) |
| Febrile neutropenia | 2 (3.7) | 13 (25.5) |
| Hypotension | 2 (3.7) | 1 (2.0) |
| Hypokalemia | 1 (1.9) | 2 (3.9) |
| Epistaxis | 0 | 3 (5.9) |
| Cytopeniah | 0 | 2 (3.9) |
| Hepatotoxicity not otherwise specified | 0 | 2 (3.9) |
Adverse events were coded with MedDRA version 22.1 and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. Patients who experienced the same event multiple times were counted once and their worst grade is reported.
Serious adverse events included events that were fatal; were life threatening; required hospitalization or prolonged hospitalization; resulted in disability or incapacity, congenital anomaly, or birth defect; or were other medically significant events as determined by the reporter. There were no fatal adverse events in either group. Seriousness criteria are defined by regulations. Grading is a measurement of severity against a predefined scale. Although there exists some overlap between seriousness and grading (eg, grade 5 and fatal events), they are not entirely synonymous.
Adverse events for MedDRA-preferred terms “thrombocytopenia” and “platelet count decreased.”
Adverse events for MedDRA-preferred terms “stomatitis” and “mucosal inflammation”; occurred after completion of blinatumomab treatment and considered to be unrelated to blinatumomab treatment.
Adverse events for MedDRA-preferred terms “neutropenia” and “neutrophil count decreased.”
Adverse events for MedDRA-preferred terms “leukopenia” and “white blood cell count decreased.”
Alanine aminotransferase increased, alanine aminotransferase, aspartate aminotransferase increased, aspartate aminotransferase, γ-glutamyltransferase increased, or hypertransaminasemia.
One patient had pancytopenia, and 1 had cytopenia in 2 cell lines.