Table 4.
Exposure-adjusted event rates for grade ≥3 treatment-emergent AEs of clinical interest
| Blinatumomab, N = 267 (total treatment exposure, 89.0 y) | SOC chemotherapy, N = 109 (total treatment exposure, 14.8 y) | ||||
|---|---|---|---|---|---|
| No. of events | Exposure-adjusted event rate* | No. of events | Exposure-adjusted event rate* | P† | |
| Cytokine release syndrome | 14 | 0.16 | 0 | 0 | .038‡ |
| Cytokine release syndrome | 9 | 0.10 | 0 | 0 | .096 |
| Hematophagic histiocytosis | 5 | 0.06 | 0 | 0 | — |
| Cytokine storm | 0 | 0 | 0 | 0 | — |
| Tumor lysis syndrome | 8 | 0.09 | 1 | 0.07 | .780 |
| Acute pancreatitis | 1 | 0.01 | 1 | 0.07 | .232 |
| Neurologic events | 34 | 0.38 | 14 | 0.95 | .008§ |
| Headache | 1 | 0.01 | 3 | 0.20 | .006§ |
| Insomnia | 1 | 0.01 | 0 | 0 | — |
| Tremor | 1 | 0.01 | 0 | 0 | — |
| Dizziness | 1 | 0.01 | 0 | 0 | — |
| Somnolence | 3 | 0.03 | 0 | 0 | — |
| Seizure | 2 | 0.02 | 3 | 0.20 | .018§ |
| Gastrointestinal disorders | 25 | 0.28 | 22 | 1.49 | <.001§ |
| Diarrhea | 3 | 0.03 | 1 | 0.07 | .572 |
| Nausea | 0 | 0 | 3 | 0.20 | — |
| Constipation | 0 | 0 | 0 | 0 | — |
| Vomiting | 0 | 0 | 1 | 0.07 | — |
| Stomatitis | 4 | 0.05 | 2 | 0.14 | .240 |
| Abdominal pain | 4 | 0.05 | 5 | 0.34 | .004§ |
| Dyspepsia | 0 | 0 | 0 | 0 | — |
| Infections | 145 | 1.63 | 96 | 6.49 | <.001§ |
| Cytopenias | 324 | 3.64 | 297 | 20.07 | <.001§ |
| Febrile neutropenia | 71 | 0.80 | 48 | 3.24 | <.001§ |
| Neutropenia | 77 | 0.87 | 41 | 2.77 | <.001§ |
| Thrombocytopenia | 71 | 0.80 | 97 | 6.55 | <.001§ |
| Decreased platelets | 33 | 0.37 | 64 | 4.32 | <.001§ |
| Decreased white blood cells | 20 | 0.23 | 8 | 0.54 | .051 |
| Decreased neutrophils | 17 | 0.19 | 22 | 1.49 | <.001§ |
| Leukopenia | 18 | 0.20 | 5 | 0.34 | .335 |
| Decreased lymphocytes | 3 | 0.03 | 4 | 0.27 | .008§ |
| Lymphopenia | 1 | 0.01 | 0 | 0 | — |
| Elevated liver enzymes | 58 | 0.65 | 28 | 1.89 | <.001§ |
| Progressive multifocal leukoencephalopathy | 3 | 0.03 | 0 | 0 | — |
| Decreased immunoglobulins | 7 | 0.08 | 0 | 0 | — |
| Other AEs of interest | |||||
| Pyrexia | 22 | 0.25 | 8 | 0.54 | .076 |
| Anemia | 100 | 1.12 | 81 | 5.47 | <.001§ |
—, not estimable.
*
Per patient-year.
†
P value comparing blinatumomab vs SOC from a Poisson regression model using number of AEs as the dependent variable and log(exposure time) as offset.
‡
Favors SOC.
§
Favors blinatumomab arm.