TABLE 5.
Parameter | Value(s) for: |
||||
---|---|---|---|---|---|
Omadacycline dose |
Omadacycline overall (n = 26) | Placebo overall (n = 7) | |||
300 mg (n = 26) | 450 mg (n = 24) | 600 mg (n = 24) | |||
No. (%) with any TEAE | 5 (19.2) | 3 (12.5) | 6 (25.0) | 10 (38.5) | 2 (28.6) |
No. (%) with treatment-related TEAE | 4 (15.4) | 2 (8.3) | 6 (25.0) | 9 (34.6) | 1 (14.3) |
Most frequent TEAEs (seen in >1 study subject), n (%) | |||||
Nausea | 2 (7.7) | 1 (4.2) | 4 (16.7) | 6 (23.1) | 0 |
Vomiting | 2 (7.7) | 0 | 1 (4.2) | 3 (11.5) | 0 |
Diarrhea | 0 | 0 | 2 (8.3) | 2 (7.7) | 0 |
Dizziness | 2 (7.7) | 0 | 1 (4.2) | 3 (11.5) | 0 |
ALT increased | 0 | 1 (4.2) | 1 (4.2) | 2 (7.7) | 0 |
TEAEs leading to early discontinuation of study drug, n (%) | |||||
All | 1 (3.8) | 1 (4.2) | 1 (4.2) | 3 (11.5) | 1 (14.3) |
Nausea | 1 (3.8) | 0 | 0 | 1 (3.8) | 0 |
Vomiting | 1 (3.8) | 0 | 0 | 1 (3.8) | 0 |
ALT increased | 0 | 1 (4.2) | 0 | 1 (3.8) | 0 |
Lipase increased | 0 | 0 | 1 (4.2) | 1 (3.8) | 0 |
Syncope | 0 | 0 | 0 | 0 | 1b (14.3) |
Results for safety population.
Vasovagal syncope following a blood draw.