Analysis of Subjects With Specific Adverse Events
(Incidence > 5 Subjects in One or More Treatment Groups)
ASaT


Placebo

Drug High Dose

Drug Low Dose


n

(%)

n

(%)

n

(%)

APPLICATION SITE PRURITUS

6

8.7

22

27.85

22

28.57

DIARRHOEA

9

13.04

0

0

0

0

ERYTHEMA

9

13.04

14

17.72

15

19.48

HEADACHE

7

10.14

6

7.59

0

0

PRURITUS

8

11.59

26

32.91

23

29.87

UPPER RESPIRATORY TRACT INFECTION

6

8.7

0

0

0

0

APPLICATION SITE DERMATITIS

0

0

7

8.86

9

11.69

APPLICATION SITE ERYTHEMA

0

0

15

18.99

12

15.58

APPLICATION SITE IRRITATION

0

0

9

11.39

9

11.69

APPLICATION SITE VESICLES

0

0

6

7.59

0

0

DIZZINESS

0

0

12

15.19

8

10.39

HYPERHIDROSIS

0

0

8

10.13

0

0

NASOPHARYNGITIS

0

0

6

7.59

0

0

NAUSEA

0

0

6

7.59

0

0

RASH

0

0

11

13.92

13

16.88

SINUS BRADYCARDIA

0

0

8

10.13

7

9.09

VOMITING

0

0

7

8.86

0

0

COUGH

0

0

0

0

6

7.79

SKIN IRRITATION

0

0

0

0

6

7.79

This is footnote 1
This is footnote 2

Source: xxx