Table 2.
Adverse events (safety analysis set).
| Parameter, n (%) | Placebo |
Tropifexor |
|||
|---|---|---|---|---|---|
| 30 μg |
60 μg |
90 μg |
150 μg |
||
| n = 21 | n = 11 | n = 9 | n = 12 | n = 8 | |
| At least 1 AE | 16 (76.2) | 9 (81.8) | 8 (88.9) | 11 (91.7) | 8 (100) |
| Incidence ≥15% in any group | |||||
| Pruritus | 6 (28.6) | 3 (27.3) | 6 (66.7) | 5 (41.7) | 7 (87.5) |
| Grade 1 | 2 (9.5) | 2 (18.2) | 2 (22.2) | 2 (16.7) | 2 (25.0) |
| Grade 2 | 3 (14.3) | 1 (9.1) | 4 (44.4) | 3 (25.0) | 2 (25.0) |
| Grade 3 | 1 (4.8) | – | – | – | 3 (37.5) |
| Nausea | 3 (14.3) | 1 (9.1) | 1 (11.1) | 2 (16.7) | 0 (0.0) |
| Headache | 3 (14.3) | – | – | 2 (16.7) | 1 (12.5) |
| Dyspepsia | – | 1 (9.1) | 2 (22.2) | – | 1 (12.5) |
| Nasopharyngitis | 1 (4.8) | 2 (18.2) | – | 1 (8.3) | – |
| Lower abdominal pain | – | 2 (18.2) | – | – | – |
| Increased ALT | – | – | – | – | 2 (25.0) |
| Arthropod bite | – | 2 (18.2) | – | – | – |
| Muscle spasms | – | 2 (18.2) | – | – | – |
| Urinary tract infection | – | – | – | 2 (16.7) | – |
| Incidence of SAEs | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Incidence of study drug-related AEs | 9 (42.9) | 4 (36.4) | 6 (66.7) | 8 (66.7) | 8 (100.0) |
| Incidence of study drug-related AEs leading to treatment discontinuation | – | – | – | – | 3 (37.5)∗ |
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; SAE, serious adverse event.
∗
One patient owing to both insomnia and proteinuria; 1, increased AST; 2, pruritus.