Table 2. Primary and Secondary Outcomes by Treatment Group Through 28 Daysa.
| Outcome | No./Total No. (%) | Relative Risk (95% CI) | P Value | |
|---|---|---|---|---|
| Tamsulosin | Placebo | |||
| Primary outcome | ||||
| Stone passed by patient report | 128/258 (49.6) | 113/239 (47.3) | 1.05 (0.87-1.27)b | .60 |
| Secondary outcomes | ||||
| Stone passed on follow-up computed tomographyc | 102/122 (83.6) | 90/116 (77.6) | 1.08 (0.95-1.22) | .24 |
| Crossover to open label tamsulosinc | 15/214 (7.0) | 14/189 (7.4) | 0.95 (0.47-1.91) | .88 |
| Surgery for urinary stoned | 14/214 (6.5) | 13/189 (6.9) | 0.95 (0.46-1.97) | .89 |
| Hospitalization(s) due to stone | 2/226 (0.9) | 1/210 (0.5) | 1.88 (0.17-20.34) | >.99e |
| Return to work (if employed) | 202/204 (99.0) | 185/188 (98.2) | 1.00 (0.98-1.03) | .67e |
| Return emergency department visit(s) due to stone | 5/226 (2.2) | 5/210 (2.4) | 0.93 (0.27-3.16) | >.99e |
a
Data presented as n/N (%) or median (interquartile range).
b
95.8% CI adjusted for age and clinical center.
c
Phase 2 participants with follow-up computed tomographic scans.
d
Phase 2 only.
e
Fisher exact test.