Table 3. Adverse Events in a Study of the Effect of Postreinduction Consolidation With Blinatumomab vs Chemotherapy in Children, Adolescents, and Young Adults With First Relapse of B-Cell Acute Lymphoblastic Leukemia.
| Adverse event | No. (%) | |||||||
|---|---|---|---|---|---|---|---|---|
| Cycle 1 | Cycle 2 | |||||||
| Blinatumomab (n = 102) | Chemotherapy (n = 97) | Blinatumomab (n = 88) | Chemotherapy (n = 62) | |||||
| Any grade | Grade ≥3a | Any grade | Grade ≥3a | Any grade | Grade ≥3a | Any grade | Grade ≥3a | |
| Patients with any adverse event | 99 (97) | 77 (76) | 89 (92) | 88 (91) | 81 (92) | 49 (56) | 55 (89) | 52 (84) |
| Anemia | 77 (76) | 15 (15) | 63 (65) | 51 (53) | 39 (44) | 4 (5) | 36 (58) | 35 (57) |
| White blood cell decreased | 67 (66) | 25 (25) | 59 (61) | 55 (57) | 50 (57) | 13 (15) | 30 (48) | 30 (48) |
| Alanine aminotransferase increased | 65 (64) | 12 (12) | 62 (64) | 38 (39) | 37 (42) | 6 (7) | 27 (44) | 8 (13) |
| Fever | 54 (53) | 6 (6) | 24 (25) | 5 (5) | 20 (23) | 2 (2) | 20 (32) | 6 (10) |
| Neutrophil count decreased | 51 (50) | 34 (33) | 58 (60) | 57 (59) | 43 (49) | 25 (28) | 32 (52) | 31 (50) |
| Aspartate aminotransferase increased | 49 (48) | 9 (9) | 51 (53) | 14 (14) | 26 (30) | 1 (1) | 24 (39) | 3 (5) |
| Hypoalbuminemia | 47 (46) | 0 | 43 (44) | 6 (6) | 18 (21) | 0 | 23 (37) | 1 (2) |
| Lymphocyte count decreased | 43 (42) | 37 (36) | 32 (33) | 30 (31) | 33 (38) | 18 (21) | 16 (26) | 15 (24) |
| Platelet count decreased | 43 (42) | 8 (8) | 63 (65) | 56 (58) | 18 (21) | 3 (3) | 37 (60) | 34 (55) |
| Hyperglycemia | 32 (31) | 2 (2) | 24 (25) | 6 (6) | 31 (35) | 2 (2) | 19 (31) | 8 (13) |
| Hypocalcemia | 31 (30) | 2 (2) | 36 (37) | 6 (6) | 12 (14) | 0 | 18 (29) | 0 |
| Hypokalemia | 28 (28) | 7 (7) | 36 (37) | 19 (20) | 21 (24) | 2 (2) | 28 (45) | 14 (23) |
| Hypophosphatemia | 18 (18) | 0 | 18 (19) | 5 (5) | 8 (9) | 0 | 7 (11) | 2 (3) |
| Hypotension | 16 (16) | 1 (1) | 11 (11) | 7 (7) | 12 (14) | 3 (3) | 7 (11) | 4 (7) |
| Blood bilirubin increased | 15 (15) | 2 (2) | 31 (32) | 7 (7) | 4 (5) | 0 | 16 (26) | 2 (3) |
| Infectionb,c | 15 (15) | 10 (10) | 48 (49) | 39 (40) | 20 (23) | 9 (10) | 42 (68) | 38 (61) |
| Vomiting | 14 (14) | 0 | 20 (21) | 2 (2) | 15 (17) | 1 (1) | 13 (21) | 4 (7) |
| GGT increased | 12 (12) | 4 (4) | 9 (9) | 5 (5) | 5 (6) | 1 (1) | 3 (5) | 1 (2) |
| Anorexia | 11 (11) | 4 (5) | 15 (16) | 12 (12) | 6 (7) | 2 (2) | 8 (13) | 4 (7) |
| Febrile neutropeniab | 6 (6) | 5 (5) | 43 (44) | 43 (44) | 0 | 0 | 28 (45) | 28 (45) |
| Mucositis oralb | 4 (4) | 0 | 44 (45) | 25 (26) | 2 (2) | 1 (1) | 16 (26) | 5 (8) |
| Sepsisb | 1 (1) | 1 (1) | 13 (13) | 13 (13) | 2 (2) | 2 (2) | 14 (23) | 14 (23) |
| Typhlitis | 0 | 0 | 1 (1) | 1 (1) | 0 | 0 | 4 (7) | 4 (7) |
| Blinatumomab-related adverse event | ||||||||
| Cytokine release syndromed | 22 (22) | 1 (1) | NA | NA | 1 (1) | 0 | NA | NA |
| Encephalopathy | 11 (11) | 2 (2) | NA | NA | 7 (8) | 2 (2) | NA | NA |
| Seizure | 4 (4) | 1 (1) | NA | NA | 1 (1) | 0 | NA | NA |
Abbreviation: NA, not applicable.
Grading was performed according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (version 4.0). Grading ranges from 1 to 5, with 3 indicating severe or medically significant but not immediately life-threatening; 4, life-threatening and indicating urgent intervention; and 5, death. Grades were assigned by the treating physician and select serious adverse events, as defined in the protocol, are reported per federal guidelines.
These 4 adverse events of special interest were identified based on their known association with life-threatening complications.
Includes catheter-related, lung, skin, upper respiratory tract, and urinary tract infections.
Cytokine release syndrome is a toxicity caused by rapid release of cytokines into the blood known to occur with immunotherapies including blinatumomab. Signs and symptoms of cytokine release syndrome include fever, nausea, headache, rash, tachycardia, hypotension, and tachypnea.