Table 5.
Any-grade adverse reactions occurring in ≥ 10% or grade ≥ 3 occurring in ≥ 5% of the blinatumomab-treated adults in first cycle of therapy (TOWER)
| Adverse reaction | Blinatumomab (N = 267) | Standard-of-care chemotherapy (N = 109) | ||
|---|---|---|---|---|
| Any grade, n (%) | Grade ≥ 3, n (%) | Any grade, n (%) | Grade ≥ 3, n (%) | |
| Blood and lymphatic system disorders | ||||
| Neutropeniaa | 84 (31) | 76 (28) | 67 (61) | 61 (56) |
| Anemiab | 68 (25) | 52 (19) | 45 (41) | 37 (34) |
| Thrombocytopeniac | 57 (21) | 47 (18) | 42 (39) | 40 (37) |
| Leukopeniad | 21 (8) | 18 (7) | 9 (8) | 9 (8) |
| Cardiac disorders | ||||
| Arrhythmiae | 37 (14) | 5 (2) | 18 (17) | 0 (0) |
| General disorders and administration-site conditions | ||||
| Pyrexia | 147 (55) | 15 (6) | 43 (39) | 4 (4) |
| Edemaf | 48 (18) | 3 (1) | 20 (18) | 1 (1) |
| Immune system disorders | ||||
| Cytokine release syndromeg | 37 (14) | 8 (3) | 0 (0) | 0 (0) |
| Infections | ||||
| Infections—pathogen unspecified | 74 (28) | 40 (15) | 50 (46) | 35 (32) |
| Bacterial infectious disorders | 38 (14) | 19 (7) | 35 (32) | 21 (19) |
| Viral infectious disorders | 30 (11) | 4 (1) | 14 (13) | 0 (0) |
| Fungal infectious disorders | 27 (10) | 13 (5) | 15 (14) | 9 (8) |
| Injury, poisoning, and procedural complications | ||||
| Infusion-related reactionh | 79 (30) | 9 (3) | 9 (8) | 1 (1) |
| Investigations | ||||
| Hypertransaminasemiai | 40 (15) | 22 (8) | 13 (12) | 7 (6) |
| Nervous system disorders | ||||
| Headache | 61 (23) | 1 (< 1) | 30 (28) | 3 (3) |
| Skin and subcutaneous tissue disorders | ||||
| Rashj | 31 (12) | 2 (1) | 21 (19) | 0 (0) |
BLINCYTO® (blinatumomab) package insert. Thousand Oaks, CA: Amgen Inc.; 2018
Severity grading based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
aNeutropenia includes agranulocytosis, febrile neutropenia, neutropenia, and neutrophil count decrease
bAnemia includes anemia and hemoglobin decrease
cThrombocytopenia includes platelet count decrease and thrombocytopenia
dLeukopenia includes leukopenia and white blood cell count decrease
eArrhythmia includes arrhythmia, atrial fibrillation, atrial flutter, bradycardia, sinus bradycardia, sinus tachycardia, supraventricular tachycardia, and tachycardia
fEdema includes face edema, fluid retention, edema, edema peripheral, peripheral swelling, and swelling face
gCytokine release syndrome includes cytokine release syndrome and cytokine storm
hInfusion-related reaction is a composite term that includes the term infusion-related reaction and the following events occurring within the first 48 hours of infusion and the event lasting ≤ 2 days: pyrexia, cytokine release syndrome, hypotension, myalgia, acute kidney injury, hypertension, and rash erythematous
iHypertransaminasemia includes alanine aminotransferase increase, aspartate aminotransferase increase, hepatic enzyme increase, and transaminases increase
jRash includes erythema, rash, rash erythematous, rash generalized, rash macular, rash maculo-papular, rash pruritic, skin exfoliation, and toxic skin eruption