Phase 1 study of intravenous administration of the chimeric adenovirus enadenotucirev in patients undergoing primary tumor resection

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)
Asthenia^a	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)