Table 4.
Adverse events in treatment groups. Values are No (%)
| Adverse event | Amoxicillin (n=89) | Placebo (n=91) |
|---|---|---|
| Any adverse event: | 75 (84) | 76 (84) |
| Unrelated/unlikely only | 25 (28) | 45 (49) |
| Drug related, any* | 50 (56) | 31 (34) |
| Severity grade ≥2: | 39 (44) | 37 (41) |
| Unrelated/unlikely only | 17 (19) | 32 (35) |
| Drug related, any* | 22 (25) | 5 (5) |
| Any serious adverse event: | 6 (7) | 2 (2) |
| Unrelated/unlikely only | 6 (7) | 2 (2) |
| Drug related, any* | 0 | 0 |
| Reported symptoms or events†: | ||
| Abdominal pain | 11 (12) | 3 (3) |
| Diarrhoea | 17 (19) | 10 (11) |
| Rash | 19 (21) | 5 (5) |
| Vaginal Candida infection‡ | 11 (21) | 0 |
| Oral Candida infection | 1 (1) | 0 |
*
Defined as possible/probable/definite attribution to study drug by care providers. Any patient with both “unrelated/unlikely” and “drug related” adverse events is counted in the group “drug related”. “Unrelated/unlikely” and “drug related” are summed up in their respective title lines above.
†
Terms as defined by care givers (not necessarily identical to Common Terminology Criteria for Adverse Events).
‡
Analysed with only women as denominator (n=52 in each treatment group).