Table 2.
Summary of adverse eventsa
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
|---|---|---|---|---|
| Summary by dose | ||||
| 25 ng/ml | 2 | |||
| 50 ng/ml | 1 | 9 | 1 (8)b,c | |
| 100 ng/ml | 1 | 5 | 1 | 1 (15)b |
| Summary by type | ||||
| Neuropathy—motor (hemiparesis) | 2 | 1 (8)b,c | ||
| Headache | 1 | 5 | 1 | |
| Ocular/visual | 2 | |||
| Speech | 3 | |||
| Seizured | 1 | |||
| Constitutional | 1 | 1 | 1 (15)b | |
a
Events that were related to catheter placement (before TP-38 delivery) are not included. All adverse events resolved with the exception of the grade 3 and 4 events shown. For events occurring more than once, only the highest grade event for each patient is recorded. Some patients had more than one event.
b
Dose-limiting toxicities; patient numbers are shown in parentheses.
c
May have been related to recurrent tumor.
d
Overall, 5 of 20 patients (25%) had seizures prior to TP-38 therapy. These were not included as adverse events unless there was an increase in frequency.