Table 3 Changes in quantity and quality of ADR reports

ADR

116

100.0

288

100.0

ICH classification ( P = 0.566)

Serious

8

6.9

14

4.9

Non-serious

108

93.1

274

95.1

WHO-ART classification ( P = 0.015*)

Grade 1 = mild

50

43.1

107

37.2

Grade 2 = moderate

46

39.7

157

54.5

Grade 3 = severe

18

15.5

22

7.6

Grade 4 = life threatening

2

1.7

2

0.7

Causality ( P < 0.001*)

Certain

64

55.2

51

17.7

Probable/likely

24

20.7

98

34.0

Possible

19

16.4

128

44.4

Unlikely

4

3.4

5

1.7

Conditional/unclassified

0

0.0

0

0.0

Unassessable/unclassifiable

5

4.3

6

2.1