Table 2.
Treatment-emergent AEs of clinical interest grade ≥3: incidence rates
| No. of patients (%) | ||
|---|---|---|
| Event | Blinatumomab, N = 267 | SOC, N = 109 |
| Any AE | 231 (87) | 100 (92) |
| Cytokine release syndrome | 13 (5) | 0 |
| Cytokine release syndrome | 9 (3) | 0 |
| Hematophagic histiocytosis | 4 (1) | 0 |
| Cytokine storm | 0 | 0 |
| Tumor lysis syndrome | 8 (3) | 1 (1) |
| Acute pancreatitis | 1 (<1) | 1 (1) |
| Neurologic events | 25 (9) | 9 (8) |
| Headache | 1 (<1) | 3 (3) |
| Insomnia | 1 (<1) | 0 |
| Tremor | 1 (<1) | 0 |
| Dizziness | 1 (<1) | 0 |
| Somnolence | 3 (1) | 0 |
| Seizure | 2 (1) | 3 (3) |
| Gastrointestinal disorders | 19 (7) | 15 (14) |
| Diarrhea | 3 (1) | 1 (1) |
| Nausea | 0 | 3 (3) |
| Constipation | 0 | 0 |
| Vomiting | 0 | 1 (1) |
| Stomatitis | 4 (1) | 2 (2) |
| Abdominal pain | 4 (1) | 3 (3) |
| Dyspepsia | 0 | 0 |
| Infections | 91 (34) | 57 (52) |
| Cytopenias | 141 (53) | 74 (68) |
| Febrile neutropenia | 57 (21) | 38 (35) |
| Neutropenia | 47 (18) | 29 (27) |
| Thrombocytopenia | 39 (15) | 30 (28) |
| Decreased platelets | 11 (4) | 13 (12) |
| Decreased white blood cells | 12 (4) | 6 (6) |
| Decreased neutrophils | 10 (4) | 11 (10) |
| Leukopenia | 8 (3) | 5 (5) |
| Decreased lymphocytes | 3 (1) | 4 (4) |
| Lymphopenia | 1 (<1) | 0 |
| Elevated liver enzymes | 34 (13) | 16 (15) |
| Progressive multifocal leukoencephalopathy | 2 (1) | 0 |
| Decreased immunoglobulins | 7 (3) | 0 |
| Other AEs of interest | ||
| Pyrexia | 19 (7) | 5 (5) |
| Anemia | 53 (20) | 38 (35) |
Data are summarized for all patients who received at least 1 dose of study treatment.