CRS and NEs with revised AE management guidelines
| . | AE management and dose level . | |||||||
|---|---|---|---|---|---|---|---|---|
| 2 × 106 (n = 6) . | 1 × 106 original (n = 14) . | 1 × 106 revised (n = 9) . | 0.5 × 106 (n = 16) . | |||||
| Steroids | ||||||||
| For treatment of CRS | 1 (17) | 5 (36) | 5 (56) | 5 (31) | ||||
| For treatment of NEs | 3 (50) | 7 (50) | 5 (56) | 5 (31) | ||||
| Tocilizumab | ||||||||
| For treatment of CRS | 1 (17) | 9 (64) | 9 (100) | 5 (31) | ||||
| For treatment of NEs | 4 (67) | 5 (36) | 4 (44) | 1 (6) | ||||
| Vasopressors for treatment of CRS | 3 (50) | 4 (29) | 2 (22) | 3 (19) | ||||
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| AE | ||||||||
| CRS | 6 (100) | 3 (50) | 14 (100) | 4 (29) | 9 (100) | 3 (33) | 13 (81) | 4 (25) |
| Pyrexia | 6 (100) | 3 (50) | 12 (86) | 5 (36) | 9 (100) | 6 (67) | 10 (77) | 5 (31) |
| Hypotension | 4 (67) | 3 (50) | 11 (79) | 6 (43) | 6 (67) | 3 (33) | 8 (62) | 3 (19) |
| Sinus tachycardia | 2 (33) | 0 | 6 (43) | 0 | 4 (44) | 1 (11) | 2 (15) | 0 |
| Chills | 1 (17) | 0 | 5 (36) | 0 | 4 (44) | 0 | 2 (15) | 0 |
| Tachycardia | 1 (17) | 1 (17) | 4 (29) | 1 (7) | 2 (22) | 0 | 4 (31) | 0 |
| Tachypnea | 0 | 0 | 4 (29) | 1 (7) | 0 | 0 | 0 | 0 |
| Hypoxia | 2 (33) | 1 (17) | 2 (14) | 2 (14) | 3 (33) | 2 (22) | 3 (23) | 2 (15) |
| Nausea | 0 | 0 | 2 (14) | 0 | 0 | 0 | 0 | 0 |
| Fatigue | 0 | 0 | 1 (7) | 0 | 3 (33) | 0 | 1 (8) | 0 |
| Headache | 0 | 0 | 1 (7) | 0 | 2 (22) | 0 | 3 (23) | 0 |
| Hyponatremia | 0 | 0 | 1 (7) | 0 | 1 (11) | 0 | 1 (8) | 0 |
| Any NE | 5 (83) | 3 (50) | 13 (93) | 9 (64) | 7 (78) | 1 (11) | 10 (63) | 4 (25) |
| Confusional state | 2 (33) | 1 (17) | 3 (21) | 0 | 6 (67) | 1 (11) | 5 (31) | 2 (13) |
| Tremor | 1 (17) | 0 | 4 (29) | 0 | 4 (44) | 0 | 4 (25) | 0 |
| Aphasia | 0 | 0 | 6 (43) | 4 (29) | 2 (22) | 1 (11) | 2 (13) | 2 (13) |
| Encephalopathy | 4 (67) | 2 (33) | 9 (64) | 6 (43) | 2 (22) | 0 | 2 (13) | 2 (13) |
| Lethargy | 0 | 0 | 1 (7) | 0 | 2 (22) | 0 | 2 (13) | 0 |
| Mental status changes | 0 | 0 | 0 | 0 | 2 (22) | 0 | 0 | 0 |
| Agitation | 0 | 0 | 4 (29) | 1 (7) | 1 (11) | 1 (11) | 2 (13) | 0 |
| Dysarthria | 0 | 0 | 1 (7) | 1 (7) | 1 (11) | 0 | 0 | 0 |
| Restlessness | 0 | 0 | 1 (7) | 1 (7) | 1 (11) | 1 (11) | 0 | 0 |
| Seizure | 1 (17) | 0 | 2 (14) | 2 (14) | 1 (11) | 0 | 1 (6) | 0 |
| Ataxia | 0 | 0 | 1 (7) | 0 | 1 (11) | 0 | 0 | 0 |
| . | AE management and dose level . | |||||||
|---|---|---|---|---|---|---|---|---|
| 2 × 106 (n = 6) . | 1 × 106 original (n = 14) . | 1 × 106 revised (n = 9) . | 0.5 × 106 (n = 16) . | |||||
| Steroids | ||||||||
| For treatment of CRS | 1 (17) | 5 (36) | 5 (56) | 5 (31) | ||||
| For treatment of NEs | 3 (50) | 7 (50) | 5 (56) | 5 (31) | ||||
| Tocilizumab | ||||||||
| For treatment of CRS | 1 (17) | 9 (64) | 9 (100) | 5 (31) | ||||
| For treatment of NEs | 4 (67) | 5 (36) | 4 (44) | 1 (6) | ||||
| Vasopressors for treatment of CRS | 3 (50) | 4 (29) | 2 (22) | 3 (19) | ||||
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| AE | ||||||||
| CRS | 6 (100) | 3 (50) | 14 (100) | 4 (29) | 9 (100) | 3 (33) | 13 (81) | 4 (25) |
| Pyrexia | 6 (100) | 3 (50) | 12 (86) | 5 (36) | 9 (100) | 6 (67) | 10 (77) | 5 (31) |
| Hypotension | 4 (67) | 3 (50) | 11 (79) | 6 (43) | 6 (67) | 3 (33) | 8 (62) | 3 (19) |
| Sinus tachycardia | 2 (33) | 0 | 6 (43) | 0 | 4 (44) | 1 (11) | 2 (15) | 0 |
| Chills | 1 (17) | 0 | 5 (36) | 0 | 4 (44) | 0 | 2 (15) | 0 |
| Tachycardia | 1 (17) | 1 (17) | 4 (29) | 1 (7) | 2 (22) | 0 | 4 (31) | 0 |
| Tachypnea | 0 | 0 | 4 (29) | 1 (7) | 0 | 0 | 0 | 0 |
| Hypoxia | 2 (33) | 1 (17) | 2 (14) | 2 (14) | 3 (33) | 2 (22) | 3 (23) | 2 (15) |
| Nausea | 0 | 0 | 2 (14) | 0 | 0 | 0 | 0 | 0 |
| Fatigue | 0 | 0 | 1 (7) | 0 | 3 (33) | 0 | 1 (8) | 0 |
| Headache | 0 | 0 | 1 (7) | 0 | 2 (22) | 0 | 3 (23) | 0 |
| Hyponatremia | 0 | 0 | 1 (7) | 0 | 1 (11) | 0 | 1 (8) | 0 |
| Any NE | 5 (83) | 3 (50) | 13 (93) | 9 (64) | 7 (78) | 1 (11) | 10 (63) | 4 (25) |
| Confusional state | 2 (33) | 1 (17) | 3 (21) | 0 | 6 (67) | 1 (11) | 5 (31) | 2 (13) |
| Tremor | 1 (17) | 0 | 4 (29) | 0 | 4 (44) | 0 | 4 (25) | 0 |
| Aphasia | 0 | 0 | 6 (43) | 4 (29) | 2 (22) | 1 (11) | 2 (13) | 2 (13) |
| Encephalopathy | 4 (67) | 2 (33) | 9 (64) | 6 (43) | 2 (22) | 0 | 2 (13) | 2 (13) |
| Lethargy | 0 | 0 | 1 (7) | 0 | 2 (22) | 0 | 2 (13) | 0 |
| Mental status changes | 0 | 0 | 0 | 0 | 2 (22) | 0 | 0 | 0 |
| Agitation | 0 | 0 | 4 (29) | 1 (7) | 1 (11) | 1 (11) | 2 (13) | 0 |
| Dysarthria | 0 | 0 | 1 (7) | 1 (7) | 1 (11) | 0 | 0 | 0 |
| Restlessness | 0 | 0 | 1 (7) | 1 (7) | 1 (11) | 1 (11) | 0 | 0 |
| Seizure | 1 (17) | 0 | 2 (14) | 2 (14) | 1 (11) | 0 | 1 (6) | 0 |
| Ataxia | 0 | 0 | 1 (7) | 0 | 1 (11) | 0 | 0 | 0 |
Data are presented as n (%).