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 (%)a5 (100.0)12 (100.0)b
Treatment-related AE, n (%)0 (0)10 (83.3)
Any SAE, n (%)1 (20.0)3 (25.0)
 Abdominal abscess10
 Subcutaneous emphysema01
 Wound dehiscence01
Treatment-related SAE0 (0.0)0 (0.0)
Any grade 3 or 4 AEs, n (%)2 (40.0)3 (25.0)
 Abdominal abscess10
 Gastrointestinal hemorrhage10
 Wound dehiscence01
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 infection01

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)