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Table 6 Treatment-Emergent Adverse Events that Occurred in ≥ 3% of Patients (mITT Population), Number of Patients (%)

From: Efficacy and safety of tigecycline versus levofloxacin for community-acquired pneumonia

Body System

Tigecycline

Levofloxacin

Total

Fisher Exact

Adverse Event

(n = 216)

N (%)

(n = 212)

n (%)

(N = 428)

N (%)

P-Value

Any adverse event

135

62.5

100

47.2

235

54.9

0.002*

Body as a whole

29

13.4

26

12.3

55

12.9

0.774

   Headache

10

4.6

4

1.9

14

3.3

0.173

Digestive system

82

38.0

44

20.8

126

29.4

<0.001*

   Diarrhoea

16

7.4

17

8.0

33

7.7

0.858

   Nausea

58

26.9

18

8.5

76

17.8

<0.001*

   Vomiting

36

16.7

14

6.6

50

11.7

0.001*

Haemic and lymphatic system

31

14.4

11

5.2

42

9.8

0.002*

   Leukocytosis

15

6.9

2

0.9

17

4.0

0.002*

   Thrombocythaemia

11

5.1

4

1.9

15

3.5

0.112

Metabolic and nutritional

20

9.3

26

12.3

46

10.7

0.351

   ALT/SGPT increased

4

1.9

9

4.2

13

3.0

0.169

   AST/SGOT increased

4

1.9

7

3.3

11

2.6

0.378

   Hypokalaemia

1

0.5

8

3.8

9

2.1

0.019*

  1. Abbreviation: ALT/SGPT = alanine aminotransferase (serum glutamic pyruvic transaminase); AST/SGOT = aspartate aminotransferase/serum glutamic oxaloacaetic transaminase.
  2. Some subjects had more than 1 treatment-emergent adverse event.
  3. *Significant between-group difference at 0.05 level.