Table 3.
Summary of the most common AEs†
| Cohort 1 | Cohort 2 | Cohort 3 | ||||
|---|---|---|---|---|---|---|
| XEN-D0501 | XEN-D0501 | XEN-D0501 | ||||
| 1 mg twice daily | Placebo | 2.5 mg twice daily | Placebo | 5 mg twice daily | Placebo | |
| Total subjects | 12 | 12 | 11 | 12 | 12 | 11 |
| Subjects with AEs | 8 | 6 | 10 | 8 | 11 | 7 |
| AE (Preferred term) | ||||||
| Headache | 0 | 0 | 4 (4) | 1 (1) | 7 (7) | 4 (3) |
| Feeling cold | 0 | 0 | 3 (3) | 0 | 5 (5) | 0 |
| Dizziness | 0 | 0 | 1 (1) | 0 | 4 (4) | 2 (0) |
| Oropharyngeal pain | 1 (0) | 1 (0) | 1 (0) | 2 (0) | 0 | 2 (0) |
| Feeling hot | 0 | 0 | 3 (3) | 0 | 1 (1) | 1 (1) |
| Abnormal dreams | 0 | 0 | 1 (0) | 2 (0) | 0 | 1 (0) |
| Nasal congestion | 0 | 1 (0) | 1 (0) | 2 (0) | 0 | 0 |
| Nausea | 0 | 0 | 0 | 0 | 2 (2) | 2 (1) |
| Night sweats | 1 (1) | 0 | 1 (1) | 0 | 2 (2) | 0 |
| Paraesthesia | 0 | 0 | 1 (1) | 0 | 3 (3) | 0 |
| Dry throat | 0 | 0 | 3 (2) | 0 | 0 | 0 |
| Dysgeusia | 0 | 0 | 0 | 0 | 3 (3) | 0 |
| Hot flush | 0 | 0 | 0 | 0 | 3 (3) | 0 |
| Nasal pharyngitis | 0 | 2 (0) | 1 (0) | 0 | 0 | 0 |
| Burning sensation | 0 | 0 | 0 | 0 | 2 (2) | 0 |
| Erythema | 0 | 0 | 0 | 0 | 2 (0) | 0 |
| Hyperhidrosis | 0 | 0 | 0 | 0 | 2 (2) | 0 |
†
Most common is defined as any adverse event that occurred in more than one subject in any treatment group. Values are the number of subjects with all causality AEs (treatment-related AEs).