Table III.
Summary of during-treatment AEs (safety population)
| AE type | Placebo (n = 82) | GSK3772847 (n = 83) |
|---|---|---|
| AE category, no. (%) | ||
| Any AE | 37 (45) | 32 (39) |
| Treatment-related AE | 3 (4) | 8 (10) |
| AEs leading to permanent discontinuation of study treatment∗ | 4 (5) | 4 (5) |
| AEs leading to study withdrawal | 1 (1) | 0 |
| SAEs | 1 (1) | 2 (2) |
| Treatment-related SAEs | 0 | 0 |
| Fatal AEs | 0 | 0 |
| AEs by system organ class, no. (%) | ||
| Infections and infestations | 16 (20) | 15 (18) |
| Nervous system disorders | 9 (11) | 11 (13) |
| Gastrointestinal disorders | 5 (6) | 7 (8) |
| Musculoskeletal and connective tissue disorders | 3 (4) | 7 (8) |
| Respiratory, thoracic, and mediastinal disorders | 6 (7) | 4 (5) |
| Cardiac disorders | 6 (7) | 3 (4) |
| Injury, poisoning and procedural complications | 4 (5) | 3 (4) |
| Skin and subcutaneous tissue disorders | 2 (2) | 5 (6) |
| General disorders and administration site conditions | 0 | 5 (6) |
| Ear and labyrinth disorders | 2 (2) | 2 (2) |
| Investigations | 2 (2) | 2 (2) |
| Vascular disorders | 1 (1) | 1 (1) |
| Blood and lymphatic system disorders | 0 | 1 (1) |
| Eye disorders | 0 | 1 (1) |
| Immune system disorders | 0 | 1 (1) |
| Psychiatric disorders | 0 | 1 (1) |
| Reproductive system and breast disorders | 0 | 1 (1) |
| Treatment-related AEs by system organ class and preferred term, no. (%) | ||
| Cardiac disorders | 3 (4) | 3 (4) |
| Ventricular tachycardia | 2 (2) | 1 (1) |
| Rhythm idioventricular | 1 (1) | 1 (1) |
| Ventricular extrasystoles | 0 | 1 (1) |
| Musculoskeletal and connective tissue disorders | 0 | 3 (4) |
| Arthralgia | 0 | 2 (2) |
| Muscle spasms | 0 | 1 (1) |
| General disorders and administration site conditions | 0 | 2 (2) |
| Asthenia | 0 | 2 (2) |
| Chills | 0 | 1 (1) |
| Nervous system disorders | 0 | 1 (1) |
| Autonomic nervous system imbalance | 0 | 1 (1) |
| Respiratory, thoracic, and mediastinal disorders | 0 | 1 (1) |
| Bronchospasm | 0 | 1 (1) |
| Skin and subcutaneous tissue disorders | 0 | 1 (1) |
| Urticaria | 0 | 1 (1) |
During-treatment AE is defined as an AE the onset of which occurs from the date of initiation of the study treatment to 28 days after the study treatment has been stopped.
∗
Participants who discontinued the study treatment could either be withdrawn from the study or continue to complete the remaining study visits.