Table 3. Serious Adverse Events by Treatment Group.
| Serious Adverse Eventa | Children, No. (%) | ||
|---|---|---|---|
| Amoxicillin (n = 564) | Placebo (n = 562) | Overall (n = 1126) | |
| Children with at least 1 serious adverse eventb | 44 (7.8) | 54 (9.6) | 98 (8.7) |
| Pneumoniac | 34 (6.0) | 42 (7.5) | 76 (6.7) |
| Fast-breathing pneumoniad | 7 (1.2) | 12 (2.1) | 19 (1.7) |
| Chest-indrawing pneumonia | 17 (3.0) | 18 (3.2) | 35 (3.1) |
| Danger sign pneumonia | 5 (0.9) | 9 (1.6) | 14 (1.2) |
| Chest radiograph–confirmed pneumoniae | 4 (0.7) | 4 (0.7) | 8 (0.7) |
| Pneumoniaf | 1 (0.2) | 0 | 1 (0.1) |
| Nonrespiratory | 12 (2.1) | 13 (2.3) | 25 (2.2) |
| Acute gastroenteritis | 4 (0.7) | 4 (0.7) | 8 (0.7) |
| Fever | 1 (0.2) | 4 (0.7) | 5 (0.4) |
| Malaria | 2 (0.4) | 1 (0.2) | 3 (0.3) |
| Convulsion | 1 (0.2) | 1 (0.2) | 2 (0.2) |
| Urinary tract infection | 0 | 2 (0.4) | 2 (0.2) |
| Vomiting | 2 (0.4) | 0 | 2 (0.2) |
| Anemia | 0 | 1 (0.2) | 1 (0.1) |
| Epistaxis | 1 (0.2) | 0 | 1 (0.1) |
| Febrile convulsion | 1 (0.2) | 0 | 1 (0.1) |
Children may have more than 1 serious adverse event.
Occurring any time after study drug is administered to child up to 14 days after enrollment.
One child in the placebo group had a danger sign pneumonia serious adverse event before day 4 and a fast-breathing pneumonia serious adverse event after day 4.
Of the 19 fast-breathing pneumonia serious adverse events, 4 were treatment failures (in the placebo group) on day 4 and met additional treatment failure criteria. The remaining 15 serious adverse events were recurrences of fast-breathing pneumonia and, therefore, relapses after day 4.
Chest radiograph–confirmed pneumonia serious adverse events did not demonstrate fast breathing, chest indrawing, or any danger signs; however, pneumonia was diagnosed through positive results on chest radiographs.
For 1 child, no type of pneumonia was specified.