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.