Table 2.
Treatment-emergent adverse events (AEs)
| Adverse event (AE) | Placebo No. of events (no. of events/patient) |
NR No. of events (no. of events/patient) |
|---|---|---|
| Headache | 4 (1) | 0 (0) |
| Nausea | 0 (0) | 1 (1) |
| Skin rash | 1 (1) | 1 (1) |
| Flushing/Hot flashes | 2 (1) | 1 (1) |
| Fainting | 1 (1) | 0 (0) |
| Drowsiness | 1 (1) | 0 (0) |
| Leg cramps | 0 (0) | 1 (1) |
| Increased bruising | 0 (0) | 1 (1) |
Data represent number (n) of times AE was reported. Number of subjects reporting AEs (n = 7); Number of subjects reporting ≥2 AE (n = 5)
Obtained from self-report during bi-weekly check-in visits over each phase. Based on N = 30 randomized subjects