Table III.
Efficacy variables for the full analysis set population.
| Variable | Time lapse group (n = 369) | Control group (n = 376) | P-value | Difference between groups Mean (95% CI) | Relative risk (95% CI) |
|---|---|---|---|---|---|
| Primary efficacy variable | |||||
| No. of ongoing pregnancies (%) | 175 (47.4%) | 181 (48.1%) | 0.90 | −0.7 (−8.2, 6.7) | 0.985 (0.848, 1.145) |
| (42.2–52.7%) | (43.0–53.3%) | ||||
| Secondary efficacy variables | |||||
| No. of positive β-hCG pregnancies (%) | 222 (60.2%) | 222 (59.0%) | 0.81 | 1.1 (−6.2, 8.4) | 1.019 (0.905, 1.147) |
| (55.0–65.2%) | (53.9–64.1%) | ||||
| No. of early pregnancy losses (%) | 47 (21.2%) | 41 (18.5%) | 0.55 | 2.7 (−5.2, 10.6) | 1.146 (0.788, 1.668) |
| (16.0–27.1%) | (13.6–24.2%) |
For categorical variables, n (%) and exact 95% CI is presented. For comparison between groups, Fisher’s exact test (lowest one-sided P-value multiplied by 2) was used for dichotomous variables. The CI for dichotomous variables is the unconditional exact confidence limits. If no exact limits can be computed the asymptotic Wald confidence limits with continuity correction are calculated instead.