Table 2 Summary of TEAEs by system organ class and preferred term in patients with CHB (safety population)
TEAE, n (%) system organ class preferred term | Treatment-naïve | On-NA | ||||
|---|---|---|---|---|---|---|
Bepirovirsen 150 mg (n = 6) | Bepirovirsen 300 mg (n = 12) | Total (n = 18) | Placebo (n = 6) | Bepirovirsen 300 mg (n = 5) | Placebo (n = 2) | |
Patients with ≥1 TEAE | 5 (83.3) | 6 (50.0) | 11 (61.1) | 3 (50.0) | 3 (60.0) | 1 (50.0) |
General disorders and administration site conditions | 4 (66.7) | 5 (41.7) | 9 (50.0) | 2 (33.3) | 3 (60.0) | 0 |
Chest discomfort | 0 | 1 (8.3) | 1 (5.6) | 0 | 0 | 0 |
Influenza-like illness | 0 | 0 | 0 | 1 (16.7) | 0 | 0 |
Injection site bruising | 1 (16.7) | 0 | 1 (5.6) | 0 | 1 (20.0) | 0 |
Injection site erythema | 0 | 3 (25.0) | 3 (16.7) | 0 | 1 (20.0) | 0 |
Injection site pain | 1 (16.7) | 1 (8.3) | 2 (11.1) | 0 | 0 | 0 |
Injection site pruritus | 2 (33.3) | 1 (8.3) | 3 (16.7) | 0 | 0 | 0 |
Injection site rash | 1 (16.7) | 0 | 1 (5.6) | 0 | 0 | 0 |
Injection site swelling | 0 | 2 (16.7) | 2 (11.1) | 0 | 1 (20.0) | 0 |
Pyrexia | 1 (16.7) | 3 (25.0) | 4 (22.2) | 1 (16.7) | 1 (20.0) | 0 |
Gastrointestinal disorders | 2 (33.3) | 3 (25.0) | 5 (27.8) | 1 (16.7) | 0 | 0 |
Abdominal discomfort | 1 (16.7) | 0 | 1 (5.6) | 0 | 0 | 0 |
Abdominal pain upper | 0 | 1 (8.3) | 1 (5.6) | 0 | 0 | 0 |
Gastritis | 0 | 0 | 0 | 1 (16.7) | 0 | 0 |
Mouth swelling | 1 (16.7) | 0 | 1 (5.6) | 0 | 0 | 0 |
Nausea | 1 (16.7) | 2 (16.7) | 3 (16.7) | 1 (16.7) | 0 | 0 |
Investigations | 0 | 3 (25.0) | 3 (16.7) | 0 | 0 | 0 |
ALT increased | 0 | 2 (16.7) | 2 (11.1) | 0 | 0 | 0 |
CRP increased | 0 | 1 (8.3) | 1 (5.6) | 0 | 0 | 0 |
Blood and lymphatic system disorders | 1 (16.7) | 1 (8.3) | 2 (11.1) | 0 | 0 | 0 |
Anemia | 1 (16.7) | 1 (8.3) | 2 (11.1) | 0 | 0 | 0 |
Infections and infestations | 0 | 2 (16.7) | 2 (11.1) | 0 | 0 | 0 |
Hand-foot-and-mouth disease | 0 | 1 (8.3) | 1 (5.6) | 0 | 0 | 0 |
Influenza | 0 | 1 (8.3) | 1 (5.6) | 0 | 0 | 0 |
Musculoskeletal and connective tissue disorders | 0 | 2 (16.7) | 2 (11.1) | 0 | 0 | 0 |
Myalgia | 0 | 2 (16.7) | 2 (11.1) | 0 | 0 | 0 |
Nervous system disorders | 0 | 2 (16.7) | 2 (11.1) | 1 (16.7) | 0 | 1 (50.0) |
Headache | 0 | 2 (16.7) | 2 (11.1) | 1 (16.7) | 0 | 1 (50.0) |
Skin and subcutaneous tissue disorders | 0 | 2 (16.7) | 2 (11.1) | 1 (16.7) | 0 | 0 |
Post inflammatory pigmentation change | 0 | 1 (8.3) | 1 (5.6) | 0 | 0 | 0 |
Pruritus generalized | 0 | 1 (8.3) | 1 (5.6) | 0 | 0 | 0 |
Rash maculo-papular | 0 | 0 | 0 | 1 (16.7) | 0 | 0 |
Urticaria | 0 | 1 (8.3) | 1 (5.6) | 0 | 0 | 0 |
Injury, poisoning, and procedural complications | 0 | 1 (8.3) | 1 (5.6) | 0 | 0 | 0 |
Contusion | 0 | 1 (8.3) | 1 (5.6) | 0 | 0 | 0 |
