Treatment-emergent AEs of clinical interest grade ≥3: incidence rates in cycles 1 and 2
| . | Blinatumomab, N = 267 . | SOC, N = 109 . | ||
|---|---|---|---|---|
| Cycle 1, n = 267 . | Cycle 2, n = 151 . | Cycle 1, n = 109 . | Cycle 2, n = 28 . | |
| Any AE | 202 (76) | 56 (37) | 98 (90) | 20 (71) |
| Cytokine release syndrome | 11 (4) | 1 (1) | 0 | 0 |
| Cytokine release syndrome | 8 (3) | 1 (1) | 0 | 0 |
| Hematophagic histiocytosis | 3 (1) | 0 | 0 | 0 |
| Cytokine storm | 0 | 0 | 0 | 0 |
| Tumor lysis syndrome | 8 (3) | 0 | 1 (1) | 0 |
| Acute pancreatitis | 1 (<1) | 0 | 0 | 1 (4) |
| Neurologic events | 19 (7) | 4 (3) | 9 (8) | 1 (4) |
| Headache | 1 (<1) | 0 | 3 (3) | 0 |
| Insomnia | 1 (<1) | 0 | 0 | 0 |
| Tremor | 1 (<1) | 0 | 0 | 0 |
| Dizziness | 1 (<1) | 0 | 0 | 0 |
| Somnolence | 3 (1) | 0 | 0 | 0 |
| Seizure | 2 (1) | 0 | 3 (3) | 0 |
| Gastrointestinal disorders | 11 (4) | 3 (2) | 12 (11) | 3 (11) |
| Diarrhea | 2 (1) | 1 (1) | 1 (1) | 0 |
| Nausea | 0 | 0 | 3 (3) | 0 |
| Constipation | 0 | 0 | 0 | 0 |
| Vomiting | 0 | 0 | 0 | 1 (4) |
| Stomatitis | 0 | 2 (1) | 2 (2) | 0 |
| Abdominal pain | 3 (1) | 0 | 2 (2) | 1 (4) |
| Dyspepsia | 0 | 0 | 0 | 0 |
| Infections | 61 (23) | 17 (11) | 52 (48) | 8 (29) |
| Cytopenias | 118 (44) | 24 (16) | 74 (68) | 17 (61) |
| Febrile neutropenia | 52 (19) | 5 (3) | 36 (33) | 9 (32) |
| Neutropenia | 28 (10) | 14 (9) | 28 (26) | 7 (25) |
| Thrombocytopenia | 37 (14) | 0 | 29 (27) | 9 (32) |
| Decreased platelets | 10 (4) | 1 (1) | 11 (10) | 3 (11) |
| Decreased white blood cells | 10 (4) | 2 (1) | 5 (5) | 1 (4) |
| Decreased neutrophils | 7 (3) | 1 (1) | 9 (8) | 5 (18) |
| Leukopenia | 8 (3) | 2 (1) | 4 (4) | 1 (4) |
| Decreased lymphocytes | 2 (1) | 0 | 4 (4) | 0 |
| Lymphopenia | 1 (<1) | 0 | 0 | 0 |
| Elevated liver enzymes | 32 (12) | 2 (1) | 14 (13) | 3 (11) |
| Progressive multifocal leukoencephalopathy | 1 (<1) | 0 | 0 | 0 |
| Decreased immunoglobulins | 0 | 3 (2) | 0 | 0 |
| Other AEs of interest | ||||
| Pyrexia | 15 (6) | 2 (1) | 4 (4) | 1 (4) |
| Anemia | 51 (19) | 1 (1) | 37 (34) | 9 (32) |
| . | Blinatumomab, N = 267 . | SOC, N = 109 . | ||
|---|---|---|---|---|
| Cycle 1, n = 267 . | Cycle 2, n = 151 . | Cycle 1, n = 109 . | Cycle 2, n = 28 . | |
| Any AE | 202 (76) | 56 (37) | 98 (90) | 20 (71) |
| Cytokine release syndrome | 11 (4) | 1 (1) | 0 | 0 |
| Cytokine release syndrome | 8 (3) | 1 (1) | 0 | 0 |
| Hematophagic histiocytosis | 3 (1) | 0 | 0 | 0 |
| Cytokine storm | 0 | 0 | 0 | 0 |
| Tumor lysis syndrome | 8 (3) | 0 | 1 (1) | 0 |
| Acute pancreatitis | 1 (<1) | 0 | 0 | 1 (4) |
| Neurologic events | 19 (7) | 4 (3) | 9 (8) | 1 (4) |
| Headache | 1 (<1) | 0 | 3 (3) | 0 |
| Insomnia | 1 (<1) | 0 | 0 | 0 |
| Tremor | 1 (<1) | 0 | 0 | 0 |
| Dizziness | 1 (<1) | 0 | 0 | 0 |
| Somnolence | 3 (1) | 0 | 0 | 0 |
| Seizure | 2 (1) | 0 | 3 (3) | 0 |
| Gastrointestinal disorders | 11 (4) | 3 (2) | 12 (11) | 3 (11) |
| Diarrhea | 2 (1) | 1 (1) | 1 (1) | 0 |
| Nausea | 0 | 0 | 3 (3) | 0 |
| Constipation | 0 | 0 | 0 | 0 |
| Vomiting | 0 | 0 | 0 | 1 (4) |
| Stomatitis | 0 | 2 (1) | 2 (2) | 0 |
| Abdominal pain | 3 (1) | 0 | 2 (2) | 1 (4) |
| Dyspepsia | 0 | 0 | 0 | 0 |
| Infections | 61 (23) | 17 (11) | 52 (48) | 8 (29) |
| Cytopenias | 118 (44) | 24 (16) | 74 (68) | 17 (61) |
| Febrile neutropenia | 52 (19) | 5 (3) | 36 (33) | 9 (32) |
| Neutropenia | 28 (10) | 14 (9) | 28 (26) | 7 (25) |
| Thrombocytopenia | 37 (14) | 0 | 29 (27) | 9 (32) |
| Decreased platelets | 10 (4) | 1 (1) | 11 (10) | 3 (11) |
| Decreased white blood cells | 10 (4) | 2 (1) | 5 (5) | 1 (4) |
| Decreased neutrophils | 7 (3) | 1 (1) | 9 (8) | 5 (18) |
| Leukopenia | 8 (3) | 2 (1) | 4 (4) | 1 (4) |
| Decreased lymphocytes | 2 (1) | 0 | 4 (4) | 0 |
| Lymphopenia | 1 (<1) | 0 | 0 | 0 |
| Elevated liver enzymes | 32 (12) | 2 (1) | 14 (13) | 3 (11) |
| Progressive multifocal leukoencephalopathy | 1 (<1) | 0 | 0 | 0 |
| Decreased immunoglobulins | 0 | 3 (2) | 0 | 0 |
| Other AEs of interest | ||||
| Pyrexia | 15 (6) | 2 (1) | 4 (4) | 1 (4) |
| Anemia | 51 (19) | 1 (1) | 37 (34) | 9 (32) |
Values are n (%).