TABLE 1.
Cumulative adverse events: severity and causality
| Maximum Severity | Any Relationship (n = 54) | Attribution to Study Procedure (n = 21) | Attribution to Study Drug (n = 16) | Unrelated to Study (n = 17) | Resolved (n = 39) | Unresolved (n = 15) |
|---|---|---|---|---|---|---|
| Grade 1 | 29 (54%) | 13 | 8 | 8 | 27 | 2 |
| Grade 2 | 23 (43%) | 8 | 8 | 7 | 11 | 12 |
| Grade 3 | 2 (3%) | 0 | 0 | 2 | 1 | 1 |
| Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Grade 5* | 0 | 0 | 0 | 0 | 0 | 0 |
All patients ultimately died from progression of the underlying disease (documented MRI progression of disease process beyond its extent at the time of infusion).