Table 3.
Adverse events, cytokine release syndrome, and neurologic events.
| N=55 | ||||||
|---|---|---|---|---|---|---|
| n (%)* | Any grade | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
| Any adverse event | 55 (100) | 0 | 3 (5) | 8 (15) | 34 (62) | 10 (18)† |
| Pyrexia | 52 (95) | 8 (15) | 24 (44) | 17 (31) | 3 (5) | 0 |
| Hypotension | 37 (67) | 2 (4) | 19 (35) | 13 (24) | 3 (5) | 0 |
| Anemia | 29 (53) | 0 | 2 (4) | 25 (45) | 2 (4) | 0 |
| Nausea | 21 (38) | 12 (22) | 9 (16) | 0 | 0 | 0 |
| Sinus tachycardia | 21 (38) | 9 (16) | 9 (16) | 3 (5) | 0 | 0 |
| Headache | 20 (36) | 12 (22) | 8 (15) | 0 | 0 | 0 |
| Chills | 18 (33) | 13 (24) | 5 (9) | 0 | 0 | 0 |
| Platelet count decreased | 18 (33) | 1 (2) | 0 | 3 (5) | 14 (25) | 0 |
| Hypoxia | 16 (29) | 1 (2) | 4 (7) | 7 (13) | 4 (7) | 0 |
| Fatigue | 15 (27) | 12 (22) | 3 (5) | 0 | 0 | 0 |
| Hypokalemia | 15 (27) | 5 (9) | 6 (11) | 3 (5) | 1 (2) | 0 |
| Hypophosphatemia | 15 (27) | 2 (4) | 2 (4) | 11 (20) | 0 | 0 |
| Neutrophil count decreased | 15 (27) | 0 | 0 | 1 (2) | 14 (25) | 0 |
| Tremor | 15 (27) | 14 (25) | 0 | 1 (2) | 0 | 0 |
| Confusional state | 14 (25) | 5 (9) | 7 (13) | 2 (4) | 0 | 0 |
| Tachycardia | 14 (25) | 3 (5) | 11 (20) | 0 | 0 | 0 |
| White blood cell count decreased | 14 (25) | 0 | 1 (2) | 4 (7) | 9 (16) | 0 |
| Alanine aminotransferase increased | 12 (22) | 4 (7) | 1 (2) | 6 (11) | 1 (2) | 0 |
| Diarrhea | 12 (22) | 7 (13) | 3 (5) | 2 (4) | 0 | 0 |
| Encephalopathy | 12 (22) | 1 (2) | 7 (13) | 3 (5) | 1 (2) | 0 |
| Hypomagnesemia | 12 (22) | 12 (22) | 0 | 0 | 0 | 0 |
| CRS ‡ | ||||||
| Any | 49 (89) | 11 (20) | 25 (45) | 7 (13) | 6 (11) | 0 |
| Pyrexia | 46 (94) | 7 (14) | 20 (41) | 16 (33) | 3 (6) | 0 |
| Hypotension | 33 (67) | 1 (2) | 16 (33) | 13 (27) | 3 (6) | 0 |
| Sinus tachycardia | 18 (37) | 7 (14) | 8 (16) | 3 (6) | 0 | 0 |
| Chills | 14 (29) | 10 (20) | 4 (8) | 0 | 0 | 0 |
| Hypoxia | 14 (29) | 1 (2) | 2 (4) | 7 (14) | 4 (8) | 0 |
| Tachycardia | 12 (24) | 3 (6) | 9 (18) | 0 | 0 | 0 |
| Fatigue | 10 (20) | 8 (16) | 2 (4) | 0 | 0 | 0 |
| Headache | 10 (20) | 6 (12) | 4 (8) | 0 | 0 | 0 |
| Neurologic events | ||||||
| Any | 33 (60) | 6 (11) | 13 (24) | 13 (24) | 0 | 1 (2) |
| Tremor | 15 (27) | 14 (25) | 0 | 1 (2) | 0 | 0 |
| Confusional state | 14 (25) | 5 (9) | 7 (13) | 2 (4) | 0 | 0 |
| Encephalopathy | 12 (22) | 1 (2) | 7 (13) | 3 (5) | 1 (2) | 0 |
The first row (Any adverse event) shows the worst grade of adverse event. All rows subsequent to the first row show adverse events, CRS symptoms, and neurologic events of any grade occurring in ≥20% of patients. CRS was graded according to the grading system proposed by Lee et al.25 The severity of all adverse events, including neurologic events and symptoms of CRS, was graded with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4·03.
Four patients had grade 5 acute lymphocytic leukemia, and six patients had other grade 5 adverse events (brain herniation [day 8; related to KTE-X19], pneumonia [day 15], septic shock [day 18, related to conditioning chemotherapy and KTE-X19], fungal pneumonia [day 46], sepsis [day 72], and respiratory failure [day 491]).
Percentages for individual CRS symptoms were calculated out of the 49 patients who experienced CRS.
CRS=cytokine release syndrome.