Table 4.
Not done | No infection | Light | Moderate | Total | |
---|---|---|---|---|---|
(N = 44) | (N = 157) | (N = 181) | (N = 14) | (N = 396) | |
n (%) | n (%) | n (%) | n (%) | n (%) | |
Total number of children with adverse events | 2 (5) | 18 (11) | 23 (13) | 1 (7) | 44 (11) |
Diarrhea | 1 (2) | 5 (3) | 4 (2) | 0 | 10 (3) |
Abdominal pain | 0 | 1 (1) | 1 (1) | 0 | 2 (1) |
Abdominal distension | 0 | 0 | 1 (1) | 0 | 1 (<1) |
Aphthous stomatitis | 0 | 1 (1) | 0 | 0 | 1 (<1) |
Nausea | 0 | 1 (1) | 0 | 0 | 1 (<1) |
Oral pain | 0 | 0 | 1 (1) | 0 | 1 (<1) |
Pyrexia | 0 | 4 (3) | 7 (4) | 0 | 11 (3) |
Lymphadenopathy | 0 | 5 (3) | 3 (2) | 0 | 8 (2) |
Cough | 0 | 3 (2) | 2 (1) | 0 | 5 (1) |
Asthma | 0 | 0 | 1 (1) | 0 | 1 (<1) |
Dyspnoea | 0 | 1 (1) | 0 | 0 | 1 (<1) |
Epistaxis | 0 | 1 (1) | 0 | 0 | 1 (<1) |
Rhonchi | 0 | 1 (1) | 0 | 0 | 1 (<1) |
Respiratory rate increased | 0 | 0 | 2 (1) | 0 | 2 (1) |
Cardiac murmur | 1 (2) | 0 | 0 | 0 | 1 (<1) |
Respiratory rate | 0 | 0 | 1 (1) | 0 | 1 (<1) |
Bronchitis | 0 | 2 (1) | 0 | 0 | 2 (1) |
Upper respiratory tract infection | 0 | 1 (1) | 0 | 0 | 1 (<1) |
Urinary tract infection | 0 | 1 (1) | 0 | 0 | 1 (<1) |
Rash popular | 0 | 0 | 3 (2) | 0 | 3 (1) |
Dizziness | 0 | 0 | 0 | 1 (7) | 1 (<1) |
Headache | 0 | 0 | 1 (1) | 0 | 1 (<1) |
Jaundice | 0 | 0 | 1 (1) | 0 | 1 (<1) |
TEAE: treatment-emergent adverse event.