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 %) |