|
Adverse eventsa
|
Round 1
|
Round 2
|
Round 3
|
Round 4
|
Total
|
|---|
|
n/N
|
%
|
(n = 206)
|
(n = 202)
|
(n = 212)
|
(n = 831)
|
|---|
|
Diarrhea
|
15/211
|
7.1
|
14/206
|
6.8
|
19/202
|
9.4
|
17/212
|
8.0
|
65/831
|
7.8
|
|
Vomiting
|
15/211
|
7.1
|
5/206
|
2.4
|
11/202
|
5.4
|
10/212
|
4.7
|
41/831
|
4.9
|
|
Fatigue/weakness
|
2/211
|
0.9
|
2/206
|
1.0
|
6/202
|
3.0
|
3/212
|
1.4
|
13/831
|
1.6
|
|
Abdominal pain
|
1/211
|
0.5
|
2/206
|
1.0
|
1/202
|
0.5
|
1/212
|
0.5
|
5/831
|
0.6
|
|
Itching
|
1/211
|
0.5
|
5/206
|
2.4
|
6/202
|
3.0
|
2/212
|
0.9
|
14/831
|
1.7
|
|
Jaundice
|
1/211
|
0.5
|
2/206
|
1.0
|
4/202
|
2.0
|
0/212
|
0.0
|
7/831
|
0.8
|
|
Headaches
|
0/211
|
0.0
|
0/206
|
0.0
|
0/202
|
0.0
|
1/212
|
0.5
|
1/831
|
0.1
|
|
Urine discoloration
|
0/211
|
0.0
|
1/206
|
0.5
|
0/202
|
0.0
|
0/212
|
0.0
|
1/831
|
0.1
|
-
aA child can have more than one adverse event
