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Table 1 Adverse events in the safety population following IT injection or IV infusion

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

  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
  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)
  2. bSpecific AEs are listed by occurrence rather than number of patients reporting them (i.e. a patient can have more than one concomitant AE)