Table 2.
Adverse Events by Dose Level
| Grade 1 Adverse Event | N (%) | 2.5 μg | 25 μg | 100 μg |
|---|---|---|---|---|
| Number of patients | 36 | 11 | 16 | 9 |
| Nausea | 8 (22) | 2 (18) | 3 (19) | 3 (33) |
| Fatigue | 7 (19) | 3 (27) | 2* (12) | 2 (22) |
| Headache | 7 (19) | 3 (27) | 2 (12) | 2 (22) |
| Constipation | 5 (14) | 2 (18) | 2 (12) | 1 (11) |
| Asthenia | 4 (11) | 1 (9) | 1 (6) | 2 (22) |
| Pyrexia | 4 (11) | 1 (9) | 1 (6) | 1 (11) |
| Visual change | 3 (8) | 1** (6) | 2** (12) | |
| Zoster reactivation | 1 (3) | 1 (11) |
* Grade 2, one patient
** Fleeting, not associated with abnormal ophthalmologic exam