Table 4.
Serious adverse events by treatment group
| Amoxicillin | Placebo | Overall | |
| Serious adverse events per group | 46 | 56 | 102 |
| Serious adverse events (can be multiple events per child) | |||
| Pneumonia-related, n (%)* | 34 (73.9) | 43 (76.8) | 77 (75.5) |
| Chest indrawing pneumonia | 17 (50.0) | 18 (41.9) | 35 (45.5) |
| Fast breathing pneumonia | 7 (20.6) | 12 (27.9) | 19 (24.7) |
| Pneumonia with respiratory distress or WHO general danger signs | 5 (14.7) | 9 (20.9) | 14 (18.1) |
| Chest radiograph confirmed pneumonia† | 4 (11.8) | 4 (9.3) | 8 (10.4) |
| Pneumonia‡ | 1 (3.0) | 0 (0.0) | 1 (1.3) |
| Non-pneumonia related, n (%)* | 12 (26.0) | 13 (23.2) | 25 (24.5) |
| Acute gastroenteritis | 4 (33.3) | 4 (30.8) | 8 (32.0) |
| Fever | 1 (8.3) | 4 (30.8) | 5 (20.0) |
| Malaria | 2 (16.7) | 1 (7.7) | 3 (12.0) |
| Convulsion | 1 (8.3) | 1 (7.7) | 2 (8.0) |
| Urinary tract infection | 0 (0.0) | 2 (15.4) | 2 (8.0) |
| Vomiting | 2 (16.7) | 0 (0.0) | 2 (8.0) |
| Anaemia | 0 (0.0) | 1 (7.7) | 1 (4.0) |
| Epistaxis | 1 (8.3) | 0 (0.0) | 1 (4.0) |
| Febrile convulsion | 1 (8.3) | 0 (0.0) | 1 (4.0) |
*Percentages for ‘Amoxicillin’ and ‘Placebo’ columns reflect total number of children within each category by treatment group. Percentages for ‘Overall’ column reflect total number of serious adverse event cases.
†Chest radiograph performed due to persistent fever leading to identification of pneumonia.
‡Event reported from an outside hospital and hospital records did not specify type of pneumonia.