| |
Age group 1 (6 months to <2 years)
|
Age group 2 (2 to <6 years)
|
Age group 3 (6 to ≤ 12years)
|
Total (n = 141)
|
|---|
|
No. of patients with at least one adverse event
|
22 (100 %)
|
49 (100 %)
|
68 (97.1 %)
|
139 (98.6 %)
|
|
Clinical adverse events
|
|
Vomiting
|
9 (40.9 %)
|
21 (42.9 %)
|
5 (7.1 %)
|
35 (24.8 %)
|
|
Anaemia
|
1 (4.5 %)
|
7 (14.3 %)
|
13 (18.6 %)
|
21 (14.9 %)
|
|
Cough
|
2 (9.1 %)
|
4 (8.2 %)
|
2 (2.9 %)
|
8 (5.7 %)
|
|
Pyrexia
|
0 (0.0 %)
|
2 (4.1 %)
|
2 (2.9 %)
|
4 (2.8 %)
|
|
Diarrhoea
|
1 (4.5 %)
|
1 (2.0 %)
|
0 (0.0 %)
|
2 (1.4 %)
|
|
Otitis media
|
1 (4.5 %)
|
0 (0.0 %)
|
1 (1.4 %)
|
2 (1.4 %)
|
|
Headache
|
0 (0.0 %)
|
0 (0.0 %)
|
2 (2.9 %)
|
2 (1.4 %)
|
|
Hyperhidrosis
|
0 (0.0 %)
|
2 (4.1 %)
|
0 (0.0 %)
|
2 (1.4 %)
|
|
Abdominal pain
|
0 (0.0 %)
|
1 (2.0 %)
|
0 (0.0 %)
|
1 (0.7 %)
|
|
Nausea
|
0 (0.0 %)
|
1 (2.0 %)
|
0 (0.0 %)
|
1 (0.7 %)
|
|
Asthenia
|
0 (0.0 %)
|
1 (2.0 %)
|
0 (0.0 %)
|
1 (0.7 %)
|
|
Rhinitis
|
0 (0.0 %)
|
1 (2.0 %)
|
0 (0.0 %)
|
1 (0.7 %)
|
|
Varicella
|
0 (0.0 %)
|
1 (2.0 %)
|
0 (0.0 %)
|
1 (0.7 %)
|
|
Productive cough
|
1 (4.5 %)
|
0 (0.0 %)
|
0 (0.0 %)
|
1 (0.7 %)
|
|
Decreased appetite
|
0 (0.0 %)
|
1 (2.0 %)
|
0 (0.0 %)
|
1 (0.7 %)
|
