TABLE 3.
Posttreatment Efficacy Summary
| Visit | Group | P* | ||||
|---|---|---|---|---|---|---|
| 2.0 mg/wk | 1.5 mg/wk | 1.0 mg/wk | Placebo | |||
| (n = 121) | (n = 119) | (n = 126) | (n = 122) | |||
| Week 2 | Effective | 15 (12.4%) | 14 (11.8%) | 10 (7.9%) | 6 (4.9%) | 0.0648 |
| Invalid | 106 (87.6%) | 105 (88.2%) | 116 (92.1%) | 116 (95.1%) | ||
| 95% CI | 7.1%–19.6% | 6.6%–19.0% | 3.9%–14.1% | 1.8%–10.4% | ||
| P† | 0.0258 | 0.0528 | 0.2049 | |||
| Week 4 | Effective | 87 (71.9%) | 79 (66.4%) | 85 (67.5%) | 20 (16.4%) | <0.0001 |
| Invalid | 34 (28.1%) | 40 (33.6%) | 41 (32.5%) | 102 (83.6%) | ||
| 95% CI | 63.0%–79.7% | 57.2%–74.8% | 58.5%–75.5% | 10.3%–24.2% | ||
| P† | <0.0001 | <0.0001 | <0.0001 | |||
| Week 6 | Effective | 91 (75.2%) | 90 (75.6%) | 91 (72.2%) | 33 (27.0%) | <0.0001 |
| Invalid | 30 (24.8%) | 29 (24.4%) | 35 (27.8%) | 89 (73.0%) | ||
| 95% CI | 66.5%–82.6% | 66.9% ~ 83.0% | 63.5%–79.8% | 19.4%–35.8% | ||
| P† | <0.0001 | <0.0001 | <0.0001 | |||
| Week 8 | Effective | 98 (81.0%) | 100 (84.0%) | 101 (80.2%) | 34 (27.9%) | <0.0001 |
| Invalid | 23 (19.0%) | 19 (16.0%) | 25 (19.8%) | 88 (72.1%) | ||
| 95% CI | 72.9%–87.6% | 76.2%–90.1% | 72.1%–86.7% | 20.1%–36.7% | ||
| P† | <0.0001 | <0.0001 | <0.0001 | |||
The differences between each test group and placebo groups using the CMH method and their 95% CI were calculated.
*The CMH method was used to compare the difference in treatment efficacy and its 95% CI between the 4 groups at each visit; with the model accounting for center effects, the difference between each test group and placebo groups using CMH method and their 95% CI were calculated.