Table 1.
Summary of treatment-emergent adverse events by frequency and preferred term
| Single ascending dose study | |||||||
| Lucerastat 100 mg (n = 6) | Lucerastat 300 mg (n = 6) | Lucerastat 500 mg (n = 6) | Lucerastat 1000 mg (n = 6) | Lucerastat 2 x 1000 mg (n = 6) | Placebo Overall (n = 9) | Lucerastat Overall (n = 24) | |
| Number of subjects with at least one AE | 2 | 2 | 0 | 1 | 4 | 1 | 9 |
| Total number of AEs | 2 | 2 | 0 | 1 | 9 | 1 | 14 |
| Preferred term | |||||||
| Fatigue | - | - | - | - | 1 | - | 1 |
| Influenza like illness | 1 | - | - | - | - | - | 1 |
| Constipation | - | - | - | 1 | - | - | 1 |
| Abdominal upper pain | - | - | - | - | 1 | - | 1 |
| Back pain | - | - | - | - | 1 | - | 1 |
| Neck stiffness | - | - | - | - | 1 | - | 1 |
| Cough | - | - | - | - | 2 | - | 2 |
| Hot flushes | - | - | - | - | - | 1 | - |
| Headache | - | - | - | - | 2 | - | 2 |
| Paresthesia | 1 | - | - | - | - | - | 1 |
| Somnolence | - | - | - | - | 1 | - | 1 |
| Rash NOS | - | 2 | - | - | - | - | 2 |
| Multiple ascending dose study | |||||||
| Lucerastat 200 mg (n = 6) | Lucerastat 500 mg (n = 12) | Lucerastat 1000 mg (n = 6) | Placebo Overall (n = 13) | Lucerastat Overall (n = 24) | |||
| Number of subjects with at least one AE | 3 | 6 | 1 | 5 | 10 | ||
| Total number of AEs | 3 | 7 | 3 | 5 | 13 | ||
| Preferred term | |||||||
| Lymphadenitis submandibular | - | 1 | - | - | 1 | ||
| Aphthous stomatitis | - | - | 1 | - | 1 | ||
| Constipation | 1 | - | - | - | 1 | ||
| Diarrhea | - | 1 | - | - | 1 | ||
| Dyspepsia | 1 | - | - | 2 | 1 | ||
| Toothache | 1 | - | - | - | 1 | ||
| Nasopharyngitis | - | 1 | - | - | 1 | ||
| ALT increased | - | 3 | - | 1 | 3 | ||
| AST increased | - | 1 | - | - | 1 | ||
| Dizziness | - | - | - | 1 | - | ||
| Headache | - | - | 1 | - | 1 | ||
| Rash NOS | - | - | 1 | 1 | 1 | ||
AE Adverse Events, Coding details according to MedDRA version 14.0; NOS Not otherwise specified