Table S1.
Summary of AEs
| Dose group | Drug-related AEs | Common drug-related AEs* |
|---|---|---|
| Single-dose study | ||
| DWP05195 | ||
| 10 mg (n=8) | 1 (1) | Feeling hot (12.5%) |
| 20 mg (n=8) | 0 (0) | |
| 50 mg (n=8) | 2 (2) | Feeling cold (25.0%) |
| 100 mg (n=8) | 0 (0) | |
| 150 mg (n=8) | 2 (2) | Feeling cold (12.5%) |
| 250 mg (n=8) | 11 (7) | Feeling cold (50.0%), feeling hot (37.5%) |
| 400 mg (n=8) | 13 (7) | Feeling cold (62.5%), paresthesia (37.5%), pyrexia (25.0%), headache (25.0%), feeling hot (12.5%) |
| 600 mg (n=8) | 17 (8) | Feeling cold (100.0%), pyrexia (37.5%), headache (25.0%), feeling hot (12.5%), paresthesia (12.5%) |
| Placebo (n=16) | 4 (5) | Headache (12.5%), feeling hot (6.25%) |
| Multiple-dose study | ||
| DWP05195 | ||
| 100 mg (n=8) | 8 (8) | Feeling cold (37.5%), feeling hot (25.0%) |
| 200 mg (n=9) | 71 (9) | Feeling cold (100.0%), feeling hot (55.6%), headache (22.2%) |
| 300 mg (n=8) | 83 (8) | Feeling cold (100.0%), headache (37.5%), hyperhidrosis (25.0%), feeling hot (25.0%) |
| 400 mg (n=8) | 115 (8) | Feeling cold (100.0%), feeling hot (50.0%) |
| Hyperhidrosis (50.0%), headache (25.0%) | ||
| Placebo (n=8) | 16 (5) | Peripheral coldness (25.0%), headache (25.0%) |
Notes: All values are presented as the number of AEs (number of subjects with AEs). The AE was countered as drug related when its causality assessment was certain, probable, or possible.
*
Common AEs (>5% incidence for single-dose study and >20% incidence for multiple-dose study) were presented with incidence, (number of subjects with AEs/number of subjects) ×100, in each dosage group.
Abbreviation: AEs, adverse events.