Table 2.
Adverse Events, the Cytokine Release Syndrome, and Neurologic Events Associated with Treatment.*
| Event | Any Grade | Grade 1 or 2 number of patients (percent) |
Grade ≥3 |
|---|---|---|---|
| Adverse event | |||
| Any | 101 (100) | 5 (5) | 96 (95) |
| Pyrexia | 86 (85) | 72 (71) | 14 (14) |
| Neutropenia | 85 (84) | 6 (6) | 79 (78) |
| Anemia | 67 (66) | 24 (24) | 43 (43) |
| Hypotension | 60 (59) | 46 (46) | 14 (14) |
| Thrombocytopenia | 59 (58) | 21 (21) | 38 (38) |
| Nausea | 59 (58) | 59 (58) | 0 |
| Fatigue | 52 (51) | 50 (50) | 2 (2) |
| Decreased appetite | 50 (50) | 48 (48) | 2 (2) |
| Headache | 47 (47) | 46 (46) | 1 (1) |
| Diarrhea | 43 (43) | 39 (39) | 4 (4) |
| Hypoalbuminemia | 41 (41) | 40 (40) | 1 (1) |
| Hypocalcemia | 40 (40) | 34 (34) | 6 (6) |
| Chills | 39 (39) | 39 (39) | 0 |
| Tachycardia | 39 (39) | 37 (37) | 2 (2) |
| Febrile neutropenia | 35 (35) | 4 (4) | 31 (31) |
| Encephalopathy | 34 (34) | 13 (13) | 21 (21) |
| Thrombocytopenia | 59 (58) | 21 (21) | 38 (38) |
| Vomiting | 34 (34) | 33 (33) | 1 (1) |
| Hypokalemia | 33 (33) | 30 (30) | 3 (3) |
| Hyponatremia | 33 (33) | 23 (23) | 10 (10) |
| Constipation | 31 (31) | 31 (31) | 0 |
| White-cell count decreased | 31 (31) | 2 (2) | 29 (29) |
| Cytokine release syndrome | |||
| Any | 94 (93) | 81 (80) | 13 (13) |
| Pyrexia | 77 (76) | 66 (65) | 11 (11) |
| Hypotension | 41 (41) | 32 (32) | 9 (9) |
| Hypoxia | 22 (22) | 13 (13) | 9 (9) |
| Tachycardia | 21 (21) | 20 (20) | 1 (1) |
| Chills | 20 (20) | 20 (20) | 0 |
| Sinus tachycardia | 8 (8) | 8 (8) | 0 |
| Headache | 5 (5) | 5 (5) | 0 |
| Neurologic event | |||
| Any | 65 (64) | 37 (37) | 28 (28) |
| Encephalopathy | 34 (34) | 13 (13) | 21 (21) |
| Confusional state | 29 (29) | 20 (20) | 9 (9) |
| Tremor | 29 (29) | 28 (28) | 1 (1) |
| Aphasia | 18 (18) | 11 (11) | 7 (7) |
| Somnolence | 15 (15) | 8 (8) | 7 (7) |
| Agitation | 9 (9) | 5 (5) | 4 (4) |
| Memory impairment | 7 (7) | 6 (6) | 1 (1) |
| Mental-status change | 6 (6) | 4 (4) | 2 (2) |
*
Listed are adverse events that occurred in at least 30% of the patients, along with symptoms of the cytokine release syndrome and neurologic events that occurred in at least 5% of the patients. The cytokine release syndrome was categorized according to a modified grading system proposed by Lee et al.24 Individual symptoms of the cytokine release syndrome and neurologic events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.