Table 2.
Incidence of treatment-emergent adverse events occurring in at least 2 participants in any treatment group in SAD and MAD studies
| n (%) | Single ascending dose (Part A) | Multiple ascending dose (Part E) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Placebo (N = 14) |
Dersimelagon |
Placebo (N = 12) |
Dersimelagon | ||||||||||||
|
1 mg (N = 6) |
3 mg (N = 6) |
10 mg (N = 6) |
30 mg (N = 6) |
100 mg (N = 6) |
300 mg (N = 6) |
600 mg (N = 6) |
Total (N = 42) |
30 mg (N = 9) |
150 mg (N = 9) |
300 mg (N = 9) |
450 mg (N = 9) |
Total (N = 36) |
|||
| Any TEAE | 3 (21.4%) | 2 (33.3%) | 0 (0.0%) | 2 (33.3%) | 3 (50.0%) | 1 (16.7%) | 2 (33.3%) | 3 (50.0%) | 13 (31.0%) | 4 (33.3%) | 8 (88.9%) | 8 (88.9%) | 9 (100.0%) | 9 (100.0%) | 34 (94.4%) |
| Nasopharyngitis | - | - | - | - | - | - | - | - | - | - | 1 (11.1%) | 2 (22.2%) | - | - | 3 (8.3%) |
| Melanocytic naevus | - | - | - | - | - | - | - | - | - | - | - | 4 (44.4%) | 6 (66.7%) | - | 10 (27.8%) |
| Dizziness | - | - | - | - | - | - | - | - | - | - | 1 (11.1%) | - | - | 1 (11.1%) | 2 (5.6%) |
| Headache | - | - | - | - | 1 (16.7%) | - | - | 1 (16.7%) | 2 (4.8%) | 1 (8.3%) | 3 (33.3%) | - | 2 (22.2%) | 4 (44.4%) | 9 (25.0%) |
| Nausea | - | - | - | - | - | - | - | 2 (33.3%) | 2 (4.8%) | - | - | - | - | - | - |
| Constipation | - | - | - | - | - | - | - | - | - | 2 (16.7%) | - | - | 1 (11.1%) | - | 1 (2.8%) |
| Tongue pigmentation | - | - | - | - | - | - | - | - | - | - | - | - | - | 2 (22.2%) | 2 (5.6%) |
| Dermatitis contact | - | 1 (16.7%) | - | - | 1 (16.7%) | - | - | 1 (16.7%) | 3 (7.1%) | - | - | - | 1 (11.1%) | 1 (11.1%) | 2 (5.6%) |
| Dermatitis acneiform | - | - | - | - | - | - | - | - | - | - | - | - | - | 3 (33.3%) | 3 (8.3%) |
| Dry skin | - | - | - | - | - | - | - | - | - | - | - | - | - | 3 (33.3%) | 3 (8.3%) |
| Ephelides | - | - | - | - | - | - | - | - | - | - | - | - | 6 (66.7%) | - | 6 (16.7%) |
| Hair color changes | - | - | - | - | - | - | - | - | - | - | - | - | 2 (22.2%) | - | 2 (5.6%) |
| Lentigo | - | - | - | - | - | - | - | - | - | 1 (8.3%) | 6 (66.7%) | 7 (77.8%) | 6 (66.7%) | - | 19 (52.8%) |
| Skin hyperpigmentation | - | - | - | - | - | - | - | - | - | 1 (8.3%) | 2 (22.2%) | 2 (22.2%) | 7 (77.8%) | 7 (77.8%) | 18 (50.0%) |
| Arthralgia | - | - | - | - | - | - | - | - | - | - | 1 (11.1%) | - | - | 2 (22.2%) | 3 (8.3%) |
| Back pain | - | - | - | - | - | - | - | - | - | - | - | 1 (11.1%) | - | 2 (22.2%) | 3 (8.3%) |
| Vessel puncture site bruise | - | - | - | - | - | - | - | - | - | 1 (8.3%) | - | 1 (11.1%) | 1 (11.1%) | - | 2 (5.6%) |
| Procedural pain | - | - | - | - | - | - | - | - | - | - | - | - | 1 (11.1%) | 1 (11.1%) | 2 (5.6%) |
TEAEs are defined as events that started on or after the date of first dose of study drug. Total column includes all active dose levels. A dash (-) indicates there were no TEAEs reported
n number of participants meeting specified criteria, N number of participants in treatment group, TEAE treatment-emergent adverse event