TABLE 7.
Treatment-emergent adverse events in >1 patient (safety population)
| TEAE | No. (%) of patients in groupa: |
|||
|---|---|---|---|---|
| 1 (i.v. 200 mg p.o. 300 mg [n = 11]) |
2 (p.o. 300 mg [n = 10]) |
3 (p.o. 450 mg [n = 10]) |
All patients (n = 31) |
|
| Any TEAEb | 9 (81.8) | 9 (90.0) | 8 (80.0) | 26 (83.9) |
| Nausea | 8 (72.7) | 6 (60.0) | 6 (60.0) | 20 (64.5) |
| Vomiting | 4 (36.4) | 4 (40.0) | 2 (20.0) | 10 (32.3) |
| Headache | 3 (27.3) | 2 (20.0) | 1 (10.0) | 6 (19.4) |
| Amylase increased | 0 | 3 (30.0) | 1 (10.0) | 4 (12.9) |
| Vulvovaginal mycotic infection | 1 (9.1) | 1 (10.0) | 2 (20.0) | 4 (12.9) |
| Diarrhea | 0 | 2 (20.0) | 1 (10.0) | 3 (9.7) |
| Gastroesophageal reflux disease | 1 (9.1) | 0 | 1 (10.0) | 2 (6.5) |
| Pruritus | 2 (18.2) | 0 | 0 | 2 (6.5) |
a
Omadacycline doses are given in parentheses after each group. i.v., intravenous; p.o., oral.
b
TEAE, treatment-emergent adverse event.