Most commonly occurring TEAEs by system organ class (>5% patients) and preferred term (Safety Set*)
| ABX464 100 mg (N=19) | ABX464 50 mg (N=21) | Placebo (N=20) | ||||
| N | N (%) | N | N (%) | N | N (%) | |
| Any TEAEs | 93 | 18 (94.7%) | 76 | 18 (85.7%) | 34 | 14 (70.0%) |
| Gastrointestinal disorders | 44 | 16 (84.2%) | 24 | 11 (52.4%) | 2 | 2 (10.0%) |
| Abdominal pain | 1 | 1 (5.3%) | 3 | 2 (9.5%) | 0 | 0 |
| Abdominal pain upper | 10 | 4 (21.1%) | 6 | 5 (23.8%) | 1 | 1 (5.0%) |
| Diarrhoea | 11 | 7 (36.8%) | 7 | 4 (19.0%) | 1 | 1 (5.0%) |
| Dyspepsia | 3 | 3 (15.8%) | 1 | 1 (4.8%) | 0 | 0 |
| Gastrointestinal pain | 1 | 1 (5.3%) | 0 | 0 | 0 | 0 |
| Impaired gastric emptying | 1 | 1 (5.3%) | 0 | 0 | 0 | 0 |
| Nausea | 12 | 9 (47.4%) | 4 | 3 (14.3%) | 0 | 0 |
| Splenic artery aneurysm† | 1 | 1 (5.3%) | 0 | 0 | 0 | 0 |
| Vomiting | 4 | 3 (15.8%) | 2 | 2 (9.5%) | 0 | 0 |
| Nervous system disorders | 19 | 10 (52.6%) | 23 | 8 (38.1%) | 10 | 5 (25.0%) |
| Dizziness | 1 | 1 (5.3%) | 0 | 0 | 1 | 1 (5.0%) |
| Headache | 16 | 10 (52.6%) | 19 | 8 (38.1%) | 6 | 4 (20.0%) |
| Taste disorder | 1 | 1 (5.3%) | 0 | 0 | 0 | 0 |
| Tremor | 1 | 1 (5.3%) | 0 | 0 | 0 | 0 |
| Musculoskeletal and connective tissue disorders | 9 | 6 (31.6%) | 4 | 4 (19.0%) | 8 | 4 (20.0%) |
| Arthralgia | 3 | 2 (10.5%) | 0 | 0 | 1 | 1 (5.0%) |
| Musculoskeletal pain | 1 | 1 (5.3%) | 0 | 0 | 0 | 0 |
| Myalgia | 2 | 1 (5.3%) | 1 | 1 (4.8%) | 0 | 0 |
| Pain in extremity | 2 | 1 (5.3%) | 0 | 0 | 2 | 1 (5.0%) |
| Rheumatoid arthritis | 1 | 1 (5.3%) | 2 | 2 (9.5%) | 1 | 1 (5.0%) |
| Infections and infestations | 5 | 5 (26.3%) | 4 | 3 (14.3%) | 4 | 4 (20.0%) |
| COVID-19 | 0 | 0 | 0 | 0 | 2 | 2 (10.0%) |
| Oral herpes | 1 | 1 (5.3%) | 0 | 0 | 0 | 0 |
| Peritonsillar abscess | 1 | 1 (5.3%) | 0 | 0 | 0 | 0 |
| Rhinitis | 1 | 1 (5.3%) | 0 | 0 | 0 | 0 |
| Sinusitis | 1 | 1 (5.3%) | 0 | 0 | 0 | 0 |
| Urinary tract infection | 1 | 1 (5.3%) | 0 | 0 | 0 | 0 |
Number of events (n) and number and percentage of patients (N(%)).The denominator for each percentage is the number of patients within the column.
*the safety set corresponded to included patients who had received at least one dose of the study treatment.
†Asymptomatic incidental finding, unrelated.
AE, adverse event; TEAE, treatment emergent adverse event.