|
Total no. patients included in analysis
|
786
|
253
|
123
|
1162
|
|
Total no. (%) of patients in whom one or more adverse event reported
|
140 (18)
|
24 (9)
|
30 (24)
|
194
|
|
Total no. of adverse events:
|
196
|
43
|
67
|
306
|
|
Classification (aetiology):
| | | | |
|
Possibly drug-related
|
37
|
14
|
27
|
78
|
|
Not likely to be drug related
|
105
|
28
|
40
|
173
|
|
Unable to be classified
|
54
|
1
|
0
|
55
|
|
Classification of possibly drug-related events according to body system:
| | | | |
|
Generalised
|
11
|
1
|
0
|
12
|
|
Neurological
|
1
|
1
|
7
|
9
|
|
Digestive
|
18
|
10
|
8
|
36
|
|
Urogenital
|
1
|
1
|
0
|
2
|
|
Haemopoetic
|
3
|
1
|
4
|
8
|
|
Special senses (hearing)
|
3
|
0
|
5
|
8
|
|
Other
|
0
|
0
|
3
|
3
|
