Table 4.
Incidence of adverse events.
| Total events/total number | Risk ratio (95% CI) |
||
|---|---|---|---|
| Treatment | Control | ||
| Gastrointestinal reactions | 6/1109 | 9/895 | 0.67(0.25,1.76) |
| Rash | 1/1109 | 3/895 | 0.33(0.44,3.11) |
| Weakness | 2/1109 | 2/895 | 1.00(0.15,6.87) |
| Weight loss | 0/1109 | 1/895 | 0.33(0.01,8.02) |
| Frequently urination | 1/1109 | 0/895 | 3.00(0.12,72.20) |
| Tinnitus | 0/1109 | 2/895 | 0.20(0.01,4.08) |
| Genital swelling | 0/1109 | 1/895 | 0.33(0.11,8.02) |
| Elevated blood white blood cell | 0/1109 | 1/895 | 0.33(0.11,8.02) |
| Decreased hemoglobin | 2/614 | 0/610 | 5.00(0.25,102.0) |
| Elevated urine white blood cell | 1/614 | 1/610 | 1.00(0.06,15.62) |
| Total events | 13 | 20 | |
| Incidence of any adverse event | Pooled rate ratio: 0.70 (0.37,1.29) | ||