Table 4: Incidence of adverse events.

Total events/total numberRisk ratio
(95% CI)
TreatmentControl

Gastrointestinal reactions6/11099/8950.67(0.25,1.76)
Rash1/11093/8950.33(0.44,3.11)
Weakness2/11092/8951.00(0.15,6.87)
Weight loss0/11091/8950.33(0.01,8.02)
Frequently urination1/11090/8953.00(0.12,72.20)
Tinnitus0/11092/8950.20(0.01,4.08)
Genital swelling0/11091/8950.33(0.11,8.02)
Elevated blood white blood cell0/11091/8950.33(0.11,8.02)
Decreased hemoglobin2/6140/6105.00(0.25,102.0)
Elevated urine white blood cell1/6141/6101.00(0.06,15.62)
Total events1320
Incidence of any adverse eventPooled rate ratio: 0.70 (0.37,1.29)