Table 5

Serious adverse event by age and treatment group

Age group (months)AmoxicillinPlacebo
2–67–1112–2324–592–67–1112–2324–59
Serious adverse events, n97191114101715
Fast breathing pneumonia, n (%)0 (0.0%)1 (0.2%)4 (0.7%)2 (0.4%)3 (0.5%)1 (0.2%)5 (0.9%)3 (0.5%)
Chest indrawing pneumonia, n (%)6 (1.1%)1 (0.2%)7 (1.2%)3 (0.5%)10 (1.8%)1 (0.2%)6 (1.1%)1 (0.2%)
Pneumonia with respiratory distress or general danger signs, n (%)0 (0.0%)1 (0.2%)3 (0.5%)1 (0.2%)1 (0.2%)3 (0.5%)3 (0.5%)2 (0.4%)
Chest radiograph confirmed pneumonia, n (%)*1 (0.2%)1 (0.2%)2 (0.4%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)4 (0.7%)
Pneumonia, n (%)1 (0.2%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)
Acute gastroenteritis, n (%)1 (0.2%)1 (0.2%)2 (0.4%)0 (0.0%)0 (0.0%)3 (0.5%)1 (0.2%)0 (0.0%)
Fever, n (%)0 (0.0%)1 (0.2%)0 (0.0%)0 (0.0%)0 (0.0%)2 (0.4%)0 (0.0%)2 (0.4%)
Malaria, n (%)0 (0.0%)1 (0.2%)0 (0.0%)1 (0.2%)0 (0.0%)0 (0.0%)1 (0.2%)0 (0.0%)
Convulsion, n (%)0 (0.0%)0 (0.0%)0 (0.0%)1 (0.2%)0 (0.0%)0 (0.0%)1 (0.2%)0 (0.0%)
Urinary tract infection, n (%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)2 (0.4%)
Vomiting, n (%)0 (0.0%)0 (0.0%)1 (0.2%)1 (0.2%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)
Anaemia, n (%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)1 (0.2%)
Epistaxis, n (%)0 (0.0%)0 (0.0%)0 (0.0%)1 (0.2%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)
Febrile convulsion, n (%)0 (0.0%)0 (0.0%)0 (0.0%)1 (0.2%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)

  • *Chest radiograph performed due to persistent fever leading to identification of pneumonia.