Table 4 Treatment-emergent adverse events in ≥3% of mITT subjects
Adverse Event | Tigecycline | Comparator | ||
|---|---|---|---|---|
N = 268 | N = 263 | |||
n (%) | n (%) | |||
Nausea* | 117 | (43.7) | 44 | (16.7) |
Vomiting* | 64 | (23.9) | 14 | (5.3) |
Diarrhea* | 39 | (14.6) | 14 | (5.3) |
Constipation | 17 | (6.3) | 22 | (8.4) |
Dyspepsia | 17 | (6.3) | 7 | (2.7) |
Headache | 20 | (7.5) | 22 | (8.4) |
Pain† | 15 | (5.6) | 18 | (6.8) |
Abdominal pain | 17 | (6.3) | 7 | (2.7) |
Fever | 9 | (3.4) | 6 | (2.3) |
Chest pain | 6 | (2.2) | 8 | (3.0) |
Insomnia | 22 | (8.2) | 17 | (6.5) |
Anxiety | 9 | (3.4) | 7 | (2.7) |
Dizziness | 9 | (3.4) | 6 | (2.3) |
Hypokalemia* | 6 | (2.2) | 17 | (6.5) |
Pruritis | 15 | (5.6) | 16 | (6.1) |
Hypertension | 8 | (3.0) | 9 | (3.4) |
Anemia | 8 | (3.0) | 7 | (2.7) |