|
pro re nata dosing groupĀ n = 57 |
scheduled dosing group n = 56 |
Somnolence |
51 (89 %) |
39 (70%) |
Vomiting |
7 (12 %) |
13 (23%) |
Nausea |
12 (21 %) |
16 (29%) |
Epigastric pain |
7 (12 %) |
5 (9%) |
Abdominal pain |
7 (12 %) |
10 (18%) |
Headache |
11 (19 %) |
13 (23%) |
Dizziness |
18 (32 %) |
18 (32%) |
Fever |
5 (9 %) |
4 (7%) |
Other* |
1 (1 %) |
7 (13%) |
Total number of adverse-events |
120 |
125 |
Number of children with one or more adverse events |
52 (91%) |
44 (79%) |
Data are presented as number of cases (%), n=113.
*diplopia (n=3), diarrhoea (n=2), throat sore (n=2), upper respiratory track infection
(n=1), nervousness (n=1).
|