HCRU by AE type and severity (N = 127)
| Key HCRU . | CRS only* (n = 47) . | NE only* (n = 14) . | Nonconcurrent CRS and NE (n = 21)*† . | Concurrent CRS and NE (n = 45)* . | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade ≥3 . | Grade 1 . | Grade 2 . | Grade ≥3 . | Grade ≤2 CRS and NE . | Grade ≥3 CRS or NE . | Grade ≤2 CRS and NE . | Grade ≥3 CRS or NE . | Grade ≥3 CRS and NE . | |
| n (%)‡ | 33 (26.0) | 13 (10.2) | 1 (0.8) | 4 (3.1) | 3 (2.4) | 7 (5.5) | 16 (12.6) | 5 (3.9) | 29 (22.8) | 12 (9.4) | 4 (3.1) |
| Facility, n (%)§ | |||||||||||
| Standard inpatient | 33 (100.0) | 13 (100.0) | 1 (100.0) | 0 | 3 (100.0) | 7 (100.0) | 16 (100.0) | 5 (100.0) | 29 (100.0) | 11 (91.7) | 3 (75.0) |
| ICU | 0 | 2 (15.4) | 1 (100.0) | 0 | 1 (33.3) | 1 (14.3) | 1 (6.3) | 1 (20.0) | 2 (6.9) | 4 (33.3) | 4 (100.0) |
| Medications, n (%)§ | |||||||||||
| Tocilizumab only | 6 (18.2) | 5 (38.5) | 0 | 0 | 0 | 0|| | 2 (12.5) | 0 | 4 (13.8) | 1 (8.3) | 0 |
| Corticosteroids only | 0 | 2 (15.4) | 0 | 0 | 3 (100.0) | 4 (57.1) | 1 (6.3) | 2 (40.0) | 6 (20.7) | 5 (41.7) | 0 |
| Tocilizumab + corticosteroids | 0 | 2 (15.4) | 1 (100.0) | 0 | 0 | 0 | 6 (37.5) | 3 (60.0) | 11 (37.9) | 6 (50.0) | 4 (100.0) |
| Vasopressor | 0 | 1 (7.7) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.4) | 1 (8.3) | 4 (100.0) |
| Mean (SD) tocilizumab doses | 0.21 (0.5) | 0.77 (0.9) | 2 | 0 | 0 | 0 | 0.63 (0.7) | 0.8 (0.8) | 0.72 (0.8) | 0.83 (0.9) | 1.25 (0.5) |
| Mean (SD) corticosteroids, d | 0 | 0.8 (1.7) | 8 | 0 | 14.7 (22.8) | 1.4 (1.4) | 1.6 (2.3) | 11.6 (11.0) | 3.9 (7.0) | 9.5 (7.5) | 24 (28.9) |
| Procedures, n (%)§ | |||||||||||
| Dialysis | 0 | 0 | 1 (100.0) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) | 2 (50.0) |
| Mean (SD), d | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0.08 (0.3) | 5.75 (10.2) |
| Median (range) | 0 (0-0) | 0 (0-0) | 3 | 0 (0-0) | 0 (0-0) | 0 (0-0) | 0 (0-0) | 0 (0-0) | 0 (0-0) | 0 (0-1) | 0 (0-21) |
| Mechanical ventilation | 0 | 1 (7.7) | 1 (100.0) | 0 | 0 | 1 (14.3) | 1 (6.3) | 0 | 1 (3.4) | 2 (16.7) | 2 (50.0) |
| Mean (SD), d | 0 | 0.08 (0.3) | 4 | 0 | 0 | 0.14 (0.4) | 0.06 (0.25) | 0 | 0.72 (0.2) | 0.75 (2.3) | 6.5 (13) |
| Median (range) | 0 (0-0) | 0 (0-1) | 4 | 0 (0-0) | 0 (0-0) | 0 (0-1) | 0 (0-1) | 0 (0-0) | 0 (0-21) | 0 (0-8) | 4 (0-26) |
| Standard inpatient LOS, d | |||||||||||
| Median (range) | 3 (1-13) | 6 (1-11) | 1 | 0 (0-0) | 6 (1-17) | 6 (2-12) | 7 (2-14) | 21 (12-35) | 11 (2-42) | 14.5 (0-43) | 5 (0-30) |
| Mean (SD) | 4 (2.7) | 6 (2.6) | 1 (NA) | 0 (0) | 8 (8.2) | 6.1 (3.7) | 7.2 (3.4) | 20.2 (9.4) | 12.6 (8.0) | 16.8 (12.0) | 10 (13.6) |
| ICU LOS, d | |||||||||||
| Median (range) | 0 (0-0) | 0 (0-2) | 5 | 0 (0-0) | 0 (0-2) | 0 (0-3) | 0 (0-6) | 0 (0-4) | 0 (0-39) | 0 (0-57) | 15.5 (3-30) |
| Mean (SD) | 0 (0) | 0.2 (0.6) | 5 (NA) | 0 (0) | 0.7 (1.2) | 0.4 (1.1) | 0.4 (1.5) | 0.8 (1.8) | 1.4 (7.2) | 6.9 (16.3) | 16 (14.0) |
| Total LOS, d | |||||||||||
| Median (range) | 3 (1-13) | 6 (1-11) | 6 | 0 (0-0) | 6 (1-19) | 6 (2-12) | 7 (2-14) | 21 (12-35) | 11 (2-81) | 16 (9-57) | 21 (6-56) |
| Mean (SD) | 4 (2.7) | 6.2 (2.6) | 6 (NA) | 0 (0) | 8.7 (9.3) | 6.6 (4.2) | 7.6 (3.4) | 21 (9.7) | 14.1 (14.2) | 23.7 (14.6) | 26.0 (22.4) |
| Key HCRU . | CRS only* (n = 47) . | NE only* (n = 14) . | Nonconcurrent CRS and NE (n = 21)*† . | Concurrent CRS and NE (n = 45)* . | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade ≥3 . | Grade 1 . | Grade 2 . | Grade ≥3 . | Grade ≤2 CRS and NE . | Grade ≥3 CRS or NE . | Grade ≤2 CRS and NE . | Grade ≥3 CRS or NE . | Grade ≥3 CRS and NE . | |
| n (%)‡ | 33 (26.0) | 13 (10.2) | 1 (0.8) | 4 (3.1) | 3 (2.4) | 7 (5.5) | 16 (12.6) | 5 (3.9) | 29 (22.8) | 12 (9.4) | 4 (3.1) |
| Facility, n (%)§ | |||||||||||
| Standard inpatient | 33 (100.0) | 13 (100.0) | 1 (100.0) | 0 | 3 (100.0) | 7 (100.0) | 16 (100.0) | 5 (100.0) | 29 (100.0) | 11 (91.7) | 3 (75.0) |
| ICU | 0 | 2 (15.4) | 1 (100.0) | 0 | 1 (33.3) | 1 (14.3) | 1 (6.3) | 1 (20.0) | 2 (6.9) | 4 (33.3) | 4 (100.0) |
| Medications, n (%)§ | |||||||||||
| Tocilizumab only | 6 (18.2) | 5 (38.5) | 0 | 0 | 0 | 0|| | 2 (12.5) | 0 | 4 (13.8) | 1 (8.3) | 0 |
| Corticosteroids only | 0 | 2 (15.4) | 0 | 0 | 3 (100.0) | 4 (57.1) | 1 (6.3) | 2 (40.0) | 6 (20.7) | 5 (41.7) | 0 |
| Tocilizumab + corticosteroids | 0 | 2 (15.4) | 1 (100.0) | 0 | 0 | 0 | 6 (37.5) | 3 (60.0) | 11 (37.9) | 6 (50.0) | 4 (100.0) |
| Vasopressor | 0 | 1 (7.7) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.4) | 1 (8.3) | 4 (100.0) |
| Mean (SD) tocilizumab doses | 0.21 (0.5) | 0.77 (0.9) | 2 | 0 | 0 | 0 | 0.63 (0.7) | 0.8 (0.8) | 0.72 (0.8) | 0.83 (0.9) | 1.25 (0.5) |
| Mean (SD) corticosteroids, d | 0 | 0.8 (1.7) | 8 | 0 | 14.7 (22.8) | 1.4 (1.4) | 1.6 (2.3) | 11.6 (11.0) | 3.9 (7.0) | 9.5 (7.5) | 24 (28.9) |
| Procedures, n (%)§ | |||||||||||
| Dialysis | 0 | 0 | 1 (100.0) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) | 2 (50.0) |
| Mean (SD), d | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0.08 (0.3) | 5.75 (10.2) |
| Median (range) | 0 (0-0) | 0 (0-0) | 3 | 0 (0-0) | 0 (0-0) | 0 (0-0) | 0 (0-0) | 0 (0-0) | 0 (0-0) | 0 (0-1) | 0 (0-21) |
| Mechanical ventilation | 0 | 1 (7.7) | 1 (100.0) | 0 | 0 | 1 (14.3) | 1 (6.3) | 0 | 1 (3.4) | 2 (16.7) | 2 (50.0) |
| Mean (SD), d | 0 | 0.08 (0.3) | 4 | 0 | 0 | 0.14 (0.4) | 0.06 (0.25) | 0 | 0.72 (0.2) | 0.75 (2.3) | 6.5 (13) |
| Median (range) | 0 (0-0) | 0 (0-1) | 4 | 0 (0-0) | 0 (0-0) | 0 (0-1) | 0 (0-1) | 0 (0-0) | 0 (0-21) | 0 (0-8) | 4 (0-26) |
| Standard inpatient LOS, d | |||||||||||
| Median (range) | 3 (1-13) | 6 (1-11) | 1 | 0 (0-0) | 6 (1-17) | 6 (2-12) | 7 (2-14) | 21 (12-35) | 11 (2-42) | 14.5 (0-43) | 5 (0-30) |
| Mean (SD) | 4 (2.7) | 6 (2.6) | 1 (NA) | 0 (0) | 8 (8.2) | 6.1 (3.7) | 7.2 (3.4) | 20.2 (9.4) | 12.6 (8.0) | 16.8 (12.0) | 10 (13.6) |
| ICU LOS, d | |||||||||||
| Median (range) | 0 (0-0) | 0 (0-2) | 5 | 0 (0-0) | 0 (0-2) | 0 (0-3) | 0 (0-6) | 0 (0-4) | 0 (0-39) | 0 (0-57) | 15.5 (3-30) |
| Mean (SD) | 0 (0) | 0.2 (0.6) | 5 (NA) | 0 (0) | 0.7 (1.2) | 0.4 (1.1) | 0.4 (1.5) | 0.8 (1.8) | 1.4 (7.2) | 6.9 (16.3) | 16 (14.0) |
| Total LOS, d | |||||||||||
| Median (range) | 3 (1-13) | 6 (1-11) | 6 | 0 (0-0) | 6 (1-19) | 6 (2-12) | 7 (2-14) | 21 (12-35) | 11 (2-81) | 16 (9-57) | 21 (6-56) |
| Mean (SD) | 4 (2.7) | 6.2 (2.6) | 6 (NA) | 0 (0) | 8.7 (9.3) | 6.6 (4.2) | 7.6 (3.4) | 21 (9.7) | 14.1 (14.2) | 23.7 (14.6) | 26.0 (22.4) |
Lee et al12 criteria were used to determine CRS toxicity grade, and National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03)17 were used to determine NE toxicity grade.
There were no patients with nonconcurrent CRS and NEs where both events were grade ≥3.
Percentages based on patients who experienced a CRS and/or NE episode.
Percentages calculated within each column as percentage of AE type and severity.
One patient received tocilizumab as prophylaxis for CRS. However, this patient did not have graded CRS and did not receive tocilizumab for CRS management; therefore, this instance was excluded.