Table 1.
Adverse events in the safety population following IT injection or IV infusion
| CRC (IT injection, n = 5) | CRC, NSCLC, UCC, RCC (IV infusion, n = 12) | |
|---|---|---|
| Any AE, n (%)a | 5 (100.0) | 12 (100.0)b |
| Treatment-related AE, n (%) | 0 (0) | 10 (83.3) |
| Astheniaa | 0 | 4 |
| Chills | 0 | 3 |
| Neutropenia | 0 | 3 |
| Pyrexia | 0 | 3 |
| Any SAE, n (%) | 1 (20.0) | 3 (25.0) |
| Abdominal abscess | 1 | 0 |
| Enteritis | 0 | 1 |
| Subcutaneous emphysema | 0 | 1 |
| Wound dehiscence | 0 | 1 |
| Treatment-related SAE | 0 (0.0) | 0 (0.0) |
| Any grade 3 or 4 AEs, n (%) | 2 (40.0) | 3 (25.0) |
| Abdominal abscess | 1 | 0 |
| Anemia | 2 | 0 |
| Asthenia | 0 | 1 |
| Enteritis | 0 | 1 |
| Gastrointestinal hemorrhage | 1 | 0 |
| Hypertension | 0 | 1 |
| Hypocalcemia | 1 | 0 |
| Hypokalemia | 1 | 0 |
| Oliguria | 0 | 1 |
| Wound dehiscence | 0 | 1 |
| Treatment-related grade 3 or 4 AEs, n (%) | 0 (0.0) | 0 (0.0) |
| AE leading to study discontinuation, n (%) | 0 (0.0) | 1 (8.3) |
| Stoma site infection | 0 | 1 |
aThe most commonly reported AEs following IV infusion were pyrexia (58.3% of patients), asthenia (51.7% of patients), abdominal pain (33.3% of patients), and neutropenia (33.3% of patients)
bSpecific AEs are listed by occurrence rather than number of patients reporting them (i.e. a patient can have more than one concomitant AE)