Table 7 Incidence of symptomatic UTI with pyuria at 24 weeks by study arm
Low dose group, 2 × 1 mg PAC | High dose group, 2 × 18.5 mg PAC | Incidence rate ratio (95% CI) p value | |
|---|---|---|---|
Symptomatic UTI with pyuria, episodes, n (%)a | n = 73 | n = 72 | |
0 | 50 (68.5) | 53 (73.6) | |
1 | 17 (23.3) | 14 (19.4) | |
2 | 5 (6.8) | 4 (5.6) | |
3 | 0 (0.0) | 0 (0.0) | |
4 | 1 (1.4)) | 1 (1.4) | |
≥ 1 | 23 (31.5) | 19 (26.4) | |
Total symptomatic UTIs with pyuria, episodes | 31 | 26 | |
Total person-days | 10,997 | 11,088 | |
Symptomatic UTI with pyuria, annualized incidence density (95% CI) | 1.03 (0.72–1.46) | 0.86 (0.58–1.26) | 0.83 (0.49–1.40) p = 0.49 |
Symptomatic UTI with pyuria, age adjusted annualized incidence density (95% CI) | 1.24 (0.86–1.77) | 1.21 (0.77–1.89) | 0.98 (0.57–1.68) p = 0.94 |
Subgroup analyses In women with < 5 UTI in past 12 months | n = 46 | n = 51 | |
Symptomatic UTI with pyuria | 21 | 12 | |
Symptomatic UTI with pyuria, annualized incidence density (95% CI) | 1.05 (0.60–1.50) | 0.55 (0.24–0.87) | 0.53 (0.26–1.07) p = 0.08 |
Symptomatic UTI with pyuria, age-adjusted annualized incidence density (95% CI) | 1.27 (0.82–1.95) | 0.83 (0.44–1.54) | 0.65 (0.31–1.37) p = 0.26 |
Symptomatic UTI with pyuria, episodes, n (%)b | n = 73 | n = 72 | |
0 | 39 (53.4) | 45 (62.5) | |
1 | 23 (31.5) | 18 (25.0) | |
2 | 6 (8.2) | 7 (9.7) | |
3 | 4 (5.5) | 1 (1.4) | |
4 | 0 (0.0) | 1 (1.4) | |
5 | 1 (1.4) | 0 (0.0) | |
≥ 1 | 34 (46.6) | 27 (37.5) | |
Total symptomatic UTIs with pyuria, episodes | 52 | 39 | |
Total person-days | 10,997 | 11,088 | |
Symptomatic UTI with pyuria, annualized incidence density (95% CI) | 1.73 (1.32–2.27) | 1.28 (0.94–1.72) | 0.74 (0.49–1.13) p = 0.16 |
Symptomatic UTI with pyuria, age-adjusted annualized incidence density (95% CI) | 2.05 (1.54–2.71) | 1.75 (1.22–2.52) | 0.86 (0.56–1.32) p = 0.48 |
Subgroup analyses In women with < 5 UTI in past 12 months | n = 46 | n = 51 | |
Symptomatic UTI with pyuria | 35 | 17 | |
Symptomatic UTI with pyuria, age-adjusted annualized incidence density (95% CI) | 1.75 (1.26–2.20) | 0.78 (0.41–1.16) | 0.45 (0.25–0.80) p = 0.01 |
Symptomatic UTI with pyuria, age-adjusted annualized incidence density (95% CI) | 2.1 (1.50–2.94) | 1.14 (0.68–1.92) | 0.54 (0.30–0.99) p = 0.047 |