Table 4.
Serious and common non-serious adverse events by treatment group
| 3-day amoxicillin (n=1497) n (%) | 5-day amoxicillin (n=1503) n (%) | Overall (n=3000) n (%) | |
|---|---|---|---|
| Children with at least 1 serious adverse event1,2 | 147 (9.8%) | 132 (8.8%) | 279 (9.3%) |
| Children with at least 1 non-serious adverse event1,2 | 395 (26.3%) | 455 (30.3%) | 849 (28.3%) |
| Serious adverse events (can be multiple events of the same or different type per child) | |||
| Pneumonia | 135 (9%) | 118 (7.9%) | 253 (8.4%) |
| Chest-indrawing pneumonia | 61 (4.1%) | 49 (3.3%) | 110 (3.7%) |
| Danger sign pneumonia | 49 (3.3%) | 51 (3.4%) | 100 (3.3%) |
| Fast-breathing pneumonia3 | 17 (1.1%) | 14 (0.9%) | 31 (1.0%) |
| Chest radiograph-confirmed pneumonia4 | 7 (0.5%) | 3 (0.2%) | 10 (0.3%) |
| Pneumonia not otherwise specified | 1 (0.1%) | 1 (0.1%) | 2 (0.1%) |
| Non-pneumonia | 20 (1.3%) | 15 (1%) | 35 (1.2%) |
| Gastroenteritis | 8 (0.5%) | 6 (0.4%) | 14 (0.5%) |
| Fever | 3 (0.2%) | 5 (0.3%) | 8 (0.3%) |
| Malaria | 1 (0.1%) | 2 (0.1%) | 3 (0.1%) |
| Meningitis | 3 (0.2%) | 0 (0%) | 3 (0.1%) |
| Otitis media | 2 (0.1%) | 0 (0%) | 2 (0.1%) |
| Conjunctivitis | 1 (0.1%) | 0 (0%) | 1 (0%) |
| Edema | 0 (0%) | 1 (0.1%) | 1 (0%) |
| Febrile seizure | 1 (0.1%) | 0 (0%) | 1 (0%) |
| Rectal prolapse | 1 (0.1%) | 0 (0%) | 1 (0%) |
| Vomiting | 0 (0%) | 1 (0.1%) | 1 (0%) |
| Common non-serious adverse events (can be multiple events of the same or different type per child) | |||
| Gastroenteritis | 176 (11.7%) | 223 (14.9%) | 399 (13.3%) |
| Upper respiratory infection | 113 (7.5%) | 114 (7.6%) | 227 (7.6%) |
| Rash | 32 (2.1%) | 50 (3.3%) | 79 (2.6%) |
| Conjunctivitis | 21 (1.4%) | 20 (1.3%) | 41 (1.4%) |
| Rhinitis | 22 (1.5%) | 15 (1%) | 37 (1.2%) |
| Otitis media | 13 (0.9%) | 21 (1.4%) | 34 (1.1%) |
| Eczema | 15 (1.0%) | 17 (1.1%) | 32 (1.1%) |
| Oral candidiasis | 13 (0.9%) | 15 (1.0%) | 28 (0.9%) |
1
Occurring any time after study drug is administered to child up to 14 days after enrollment.
2
Children may have more than 1 serious and/or non-serious adverse event. 337 occurred on or prior to Day 6 and were treatment failures while the remaining occurred after Day 6 and thus were considered relapses. 4The chest radiograph-confirmed pneumonia serious adverse events did not demonstrate fast breathing, chest indrawing, or any danger signs; however, pneumonia was diagnosed through positive chest radiographs.