Table 2.
AEs and severe AEs
| Events | n | Grade | Subject(s) |
|---|---|---|---|
| AEs* | |||
| Dizziness | 3 | 1 | 2, 8, 14 |
| Dry mouth | 1 | 1 | 2 |
| Edema, localized | 1 | 2 | 2 |
| Headache | 1 | 2 | 5 |
| Insomnia | 4 | 2 | 5, 9, 14, 15 |
| Mood swings | 2 | 2, 1 | 5, 9 |
| Myalgia | 1 | 1 | 5 |
| Nausea | 1 | 2 | 2 |
| Palpitations | 2 | 1 | 5, 14 |
| Proteinuria | 1 | 1 | 8 |
| Rash | 2 | 1, 2 | 2, 15 |
| Severe AEs | |||
| Squamous cell carcinoma of the skin | 1 | 1 | 7 |
*
All AEs assessed as possibly, probably, or definitely related to study drug are recorded here. These AEs were self-limited, and none led to drug discontinuation. Other AEs are listed in supplemental Table 2.