Table 2.
Summary of treatment-emergent adverse events, by system organ class and severity according to treatment allocation
| System organ class | Severity | ABX464 50 mg
Total=6 |
ABX464 150 mg
Total=16 |
Placebo
Total=8 |
|||
|---|---|---|---|---|---|---|---|
| TEAEs
n |
Participants
na (%) |
TEAEs
n |
Participants
na (%) |
TEAEs
n |
Participants
na (%) |
||
| Any treatment-emergent adverse events | All | 10 | 4 (66.7) | 58 | 15 (93.8) | 13 | 3 (37.5) |
| Mild | 9 | 3 (50.0) | 38 | 6 (37.5) | 11 | 2 (25.0) | |
| Moderate | 1 | 1 (16.7) | 19 | 8 (50.0) | 2 | 1 (12.5) | |
| Severe | 0 | 0 (0.0) | 1 | 1 (6.3) | 0 | 0 (0.0) | |
| Blood and lymphatic system disorders | All | 2 | 1 (16.7) | 0 | 0 (0.0) | 0 | 0 (0.0) |
| Mild | 2 | 1 (16.7) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Moderate | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Severe | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Gastrointestinal disorders | All | 2 | 1 (16.7) | 23 | 13 (81.3) | 1 | 1 (12.5) |
| Mild | 2 | 1 (16.7) | 16 | 7 (43.8) | 1 | 1 (12.5) | |
| Moderate | 0 | 0 (0.0) | 7 | 6 (37.5) | 0 | 0 (0.0) | |
| Severe | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| General disorders and administration site conditions | All | 2 | 1 (16.7) | 10 | 6 (37.5) | 1 | 1 (12.5) |
| Mild | 1 | 0 (0.0) | 4 | 3 (18.8) | 1 | 1 (12.5) | |
| Moderate | 1 | 1 (16.7) | 5 | 2 (12.5) | 0 | 0 (0.0) | |
| Severe | 0 | 0 (0.0) | 1 | 1 (6.3) | 0 | 0 (0.0) | |
| Infections and infestations | All | 0 | 0 (0.0) | 3 | 3 (18.8) | 7 | 3 (37.5) |
| Mild | 0 | 0 (0.0) | 2 | 2 (12.5) | 5 | 2 (25.0) | |
| Moderate | 0 | 0 (0.0) | 1 | 1 (6.3) | 2 | 1 (12.5) | |
| Severe | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Injury, poisoning and procedural complications | All | 2 | 2 (33.3) | 0 | 0 (0.0) | 0 | 0 (0.0) |
| Mild | 2 | 2 (33.3) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Moderate | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Severe | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Investigations | All | 0 | 0 (0.0) | 2 | 2 (12.5) | 1 | 1 (12.5) |
| Mild | 0 | 0 (0.0) | 1 | 1 (6.3) | 1 | 1 (12.5) | |
| Moderate | 0 | 0 (0.0) | 1 | 1 (6.3) | 0 | 0 (0.0) | |
| Severe | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Metabolism and nutrition disorders | All | 0 | 0 (0.0) | 1 | 1 (6.3) | 0 | 0 (0.0) |
| Mild | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Moderate | 0 | 0 (0.0) | 1 | 1 (6.3) | 0 | 0 (0.0) | |
| Severe | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Musculoskeletal and connective tissue disorders | All | 0 | 0 (0.0) | 10 | 8 (50.0) | 2 | 2 (25.0) |
| Mild | 0 | 0 (0.0) | 7 | 5 (31.3) | 2 | 2 (25.0) | |
| Moderate | 0 | 0 (0.0) | 3 | 3 (18.8) | 0 | 0 (0.0) | |
| Severe | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Nervous system disorders | All | 2 | 2 (33.3) | 7 | 5 (31.3) | 0 | 0 (0.0) |
| Mild | 2 | 2 (33.3) | 6 | 4 (25.0) | 0 | 0 (0.0) | |
| Moderate | 0 | 0 (0.0) | 1 | 1 (6.3) | 0 | 0 (0.0) | |
| Severe | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Psychiatric disorders | All | 0 | 0 (0.0) | 1 | 1 (6.3) | 0 | 0 (0.0) |
| Mild | 0 | 0 (0.0) | 1 | 1 (6.3) | 0 | 0 (0.0) | |
| Moderate | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Severe | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Renal and urinary disorders | All | 0 | 0 (0.0) | 1 | 1 (6.3) | 0 | 0 (0.0) |
| Mild | 0 | 0 (0.0) | 1 | 1 (6.3) | 0 | 0 (0.0) | |
| Moderate | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Severe | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Skin and subcutaneous tissue disorders | All | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (12.5) |
| Mild | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (12.5) | |
| Moderate | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
| Severe | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | |
a
If a subject experienced multiple adverse events categorised under the same system organ class, this subject is shown only once within the highest severity grading. n: number of participants