Table 5.
Adverse events
| Adverse events | Total (N = 355) |
Group I | Group II | |
|---|---|---|---|---|
| Cephalexin CV (n = 174) |
Cefuroxime (n = 87) |
Co-amoxiclav (n = 94) |
||
| Alteration of taste | ||||
| Number of patients (%) | 2 (0.6) | 0 (0.0) | 1 (1.2) | 1 (1.5) |
| Duration | ||||
| Mean ± SD | 4.5 ± 0.7 | 4.0 ± 0.0 | 5.0 ± 0.0 | |
| Median | 5 | 4 | 5 | |
| Range | 4–5 | 4–4 | 5–5 | |
| Ongoing; n (%) | 2 (100.0) | 0 (0.0) | 1 (100.0) | 1 (100.0) |
| Severity; n (%) | ||||
| Mild | 1 (50.0) | 0 (0.0) | 1 (100.0) | 0 (0.0) |
| Moderate | 1 (50.0) | 0 (0.0) | 0 (0.0) | 1 (100.0) |
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Diarrhea | ||||
| Number of patients (%) | 14 (3.9) | 3 (1.7) | 1 (1.2) | 10 (10.6) |
| Duration | ||||
| Mean ± SD | 5.5 ± 1.9 | 5.0 ± 1.7 | 7.0 ± 0.0 | 5.6 ± 2.1 |
| Median | 5 | 4 | 7 | 5 |
| Range | 3–9 | 4–7 | 7–7 | 3–9 |
| Ongoing; n (%) | 4 (28.6) | 0 (0.0) | 0 (0.0) | 4 (40.0) |
| Severity; n (%) | ||||
| Mild | 6 (42.8) | 2 (66.7) | 1 (100.0) | 3 (30.0) |
| Moderate | 6 (42.8) | 0 (0.0) | 0 (0.0) | 6 (60.0) |
| Severe | 2 (14.3) | 1 (33.3) | 0 (0.0) | 1 (10.0) |
| Hyperacidity | ||||
| Number of patients (%) | 2 (0.5) | 2 (1.2) | 0 (0.0) | 0 (0.0) |
| Duration | ||||
| Mean ± SD | 3.0 ± 1.4 | 3.0 ± 1.4 | ||
| Median | 3 | 3 | ||
| Range | 2–4 | 2–4 | ||
| Ongoing; n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Severity; n (%) | ||||
| Mild | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Moderate | 1 (50.0) | 1 (50.0) | 0 (0.0) | 0 (0.0) |
| Severe | 1 (50.0) | 1 (50.0) | 0 (0.0) | 0 (0.0) |
| Nausea | ||||
| Number of patients (%) | 2 (0.5) | 2 (1.2) | 0 (0.0) | 0 (0.0) |
| Duration | ||||
| Mean ± SD | 2.5 ± 0.7 | 2.5 ± 0.7 | ||
| Median | 3 | 3 | ||
| Range | 2–3 | 2–3 | ||
| Ongoing; n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Severity; n (%) | ||||
| Mild | 2 (100.0) | 2 (100.0) | 0 (0.0) | 0 (0.0) |
| Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Skin rashes | ||||
| Number of patients (%) | 1 (0.3) | 1 (0.6) | 0 (0.0) | 0 (0.0) |
| Duration | ||||
| Mean ± SD | 3.0 ± 0.0 | 3.0 ± 0.0 | ||
| Median | 3 | 3 | ||
| Range | 3–3 | 3–3 | ||
| Ongoing; n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Severity; n (%) | ||||
| Mild | 1 (100.0) | 1 (100.0) | 0 (0.0) | 0 (0.0) |
| Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Co-amoxiclav amoxicillin–clavulanic acid, CV clavulanic acid, n number of patients, N total patients, SD standard deviation