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) |
*Significant between-group difference (p < 0.05). †Pain was a general category for any pain without a more specific category (e.g., abdominal pain). mITT, modified intent-to-treat.