50 mg ABX-464
(n=6) |
150 mg ABX-464
(n=16) |
Placebo
(n=8) |
||||
---|---|---|---|---|---|---|
E | n (%) | E | n(%) | E | n (%) | |
Any treatment-emergent adverse events | 10 | 4 (66.7%) | 58 | 15 (93.8%) | 13 | 3 (37.5%) |
Blood and lymphatic system disorders | 2 | 1 (16.7%) | 0 | 0 | 0 | 0 |
Lymphadenopathy | 2 | 1 (16.7%) | 0 | 0 | 0 | 0 |
Gastrointestinal disorders | 2 | 1 (16.7%) | 23 | 13 (81.3%) | 1 | 1 (12.5%) |
Abdominal pain | 0 | 0 | 4 | 3 (18.8%) | 0 | 0 |
Abdominal pain upper | 0 | 0 | 5 | 4 (25.0%) | 0 | 0 |
Diarrhoea | 2 | 1 (16.7%) | 5 | 3 (18.8%) | 0 | 0 |
Epigastric discomfort | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Gastric disorder | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Gastro-oesophageal reflux disease | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Nausea | 0 | 0 | 2 | 2 (12.5%) | 1 | 1 (12.5%) |
Rectal haemorrhage | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Salivary gland disorder | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Tooth infection | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Toothache | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
General disorders and administration site conditions | 2 | 1 (16.7%) | 10 | 6 (37.5%) | 1 | 1 (12.5%) |
Fatigue | 0 | 0 | 5 | 3 (18.8%) | 0 | 0 |
Inflammation | 1 | 1 (16.7%) | 0 | 0 | 0 | 0 |
Influenza like illness | 1 | 1 (16.7%) | 1 | 1 (6.3%) | 0 | 0 |
Malaise | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Oedema peripheral | 0 | 0 | 2 | 1 (6.3%) | 0 | 0 |
Peripheral swelling | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Pyrexia | 0 | 0 | 0 | 0 | 1 | 1 (12.5%) |
Infections | 0 | 0 | 3 | 3 (18.8%) | 7 | 3 (37.5%) |
Bronchitis | 0 | 0 | 0 | 0 | 1 | 1 (12.5%) |
Eye infection | 0 | 0 | 0 | 0 | 1 | 1 (12.5%) |
Nasopharyngitis | 0 | 0 | 0 | 0 | 2 | 2 (25.0%) |
Pharyngitis | 0 | 0 | 0 | 0 | 1 | 1 (12.5%) |
Rhinitis | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Sinusitis | 0 | 0 | 1 | 1 (6.3%) | 1 | 1 (12.5%) |
Syphilis | 0 | 0 | 0 | 0 | 1 | 1 (12.5%) |
Upper respiratory tract infection | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Injury, poisoning and procedural complications | 2 | 2 (33.3%) | 0 | 0 | 0 | 0 |
Contusion | 1 | 1 (16.7%) | 0 | 0 | 0 | 0 |
Scar | 1 | 1 (16.7%) | 0 | 0 | 0 | 0 |
Investigations | 0 | 0 | 2 | 2 (12.5%) | 1 | 1 (12.5%) |
Activated partial thromboplastin time prolonged | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
C-reactive protein increased | 0 | 0 | 1 | 1 (6.3%) | 1 | 1 (12.5%) |
Metabolism and nutrition disorders | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Gout | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Musculoskeletal and connective tissue disorders | 0 | 0 | 10 | 8 (50.0%) | 2 | 2 (25.0%) |
Arthralgia | 0 | 0 | 3 | 2 (12.5%) | 1 | 1 (12.5%) |
Back pain | 0 | 0 | 6 | 5 (31.3%) | 0 | 0 |
Myalgia | 0 | 0 | 0 | 0 | 1 | 1 (12.5%) |
Pain in extremity | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Nervous system disorders | 2 | 2 (33.3%) | 7 | 5 (31.3%) | 0 | 0 |
Headache | 2 | 2 (33.3%) | 7 | 5 (31.3%) | 0 | 0 |
Psychiatric disorders | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Insomnia | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Renal and urinary disorders | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Dysuria | 0 | 0 | 1 | 1 (6.3%) | 0 | 0 |
Skin and subcutaneous tissue disorders | 0 | 0 | 0 | 0 | 1 | 1 (12.5%) |
Rash | 0 | 0 | 0 | 0 | 1 | 1 (12.5%) |
E: events; n: number of participants