Table 2.
Neurotoxicity outcomes by protocol
| Protocol | Total (N = 890) |
|||
|---|---|---|---|---|
| 58741 (N = 60) |
58831/2 (N = 199) |
58881 (N = 631) |
||
| N (%) | N (%) | N (%) | N (%) | |
| Cognitive disturbance | ||||
| N available data | 29 (48.3) | 111 (55.8) | 444 (70.4) | 584 (65.6) |
| No | 10 (34.5) | 93 (83.8) | 376 (84.7) | 479 (82.0) |
| Yes, all CTCAE grades | 19 (65.5) | 18 (16.2) | 68 (15.3) | 105 (18.0) |
| Yes, CTCAE grade 1 | 6 (20.7) | 9 (8.1) | 47 (10.6) | 62 (10.6) |
| Yes, CTCAE grade 2 | 7 (24.1) | 5 (4.5) | 20 (4.5) | 32 (5.5) |
| Yes, CTCAE grade 3 | 6 (20.7) | 4 (3.6) | 1 (0.2) | 11 (1.9) |
| Seizures status | ||||
| N available data | 50 (83.3) | 189 (95.0) | 596 (94.5) | 835 (93.8) |
| No event | 24 (48.0) | 156 (82.5) | 520 (87.2) | 700 (83.8) |
| Seizures | 23 (46.0) | 27 (14.3) | 45 (7.6) | 95 (11.4) |
| Death without seizures | 3 (6.0) | 6 (3.2) | 31 (5.2) | 40 (4.8) |
| Stroke status | ||||
| N available data | 36 (60.0) | 172 (86.4) | 583 (92.4) | 791 (88.9) |
| No event | 26 (72.2) | 161 (93.6) | 537 (92.1) | 724 (91.5) |
| Stroke | 7 (19.4) | 4 (2.3) | 12 (2.1) | 23 (2.9) |
| Death without stroke | 3 (8.3) | 7 (4.1) | 34 (5.8) | 44 (5.6) |
| Leukoencephalopathy status | ||||
| N available data | 18 (30.0) | 129 (64.8) | 479 (75.9) | 626 (70.3) |
| No event | 4 (22.2) | 115 (89.1) | 438 (91.4) | 557 (89.0) |
| Leukoencephalopathy | 12 (66.7) | 8 (6.2) | 16 (3.3) | 36 (5.8) |
| Death without leukoencephalopathy | 2 (11.1) | 6 (4.7) | 25 (5.2) | 33 (5.3) |
CTCAE, Common Toxicity Criteria for Adverse Events.