Table 4 Incidence of symptomatic UTI at 24 weeks by study arm
Low dose group, 2 × 1 mg PAC (n = 73) | High dose group, 2 × 18.5 mg PAC (n = 72) | Incidence rate ratio (95% CI) | p value | |
|---|---|---|---|---|
Subjects reporting symptomatic UTI, episodes, n (%) | ||||
0 | 34 (46.6) | 41 (57.0) | ||
1 | 26 (35.6) | 21 (29.2) | ||
2 | 8 (11.0) | 7 (9.7) | ||
3 | 4 (5.5) | 2 (2.8) | ||
4 | 0 (0.0) | 1 (1.4) | ||
5 | 1 (1.4) | 0 (0.0) | ||
≥ 1 | 39 (53.4) | 31 (43.1) | ||
Total symptomatic UTIs, episodes | 59 | 45 | ||
Follow-up, days (mean ± SD) | 151 ± 43 | 154 ± 39 | ||
Total person-days | 10,997 | 11,088 | ||
UTI, annualized incidence density (95% CI)a | 1.96 (1.52–2.53) | 1.48 (1.11–1.99) | 0.76 (0.51–1.11) | 0.16 |
UTI, age-adjusted annualized incidence density (95% CI)b | 2.28 (1.74–2.98) | 1.93 (1.36–2.72) | 0.85 (0.57–1.26) | 0.42 |