TABLE 2.
PGIC and CGIC Responder Rates
| Condoliase (n=169) n (%) | Sham (n=172) n (%) | Treatment effect % (95% CI)a | P b | |
|---|---|---|---|---|
| PGIC respondersc | ||||
| Week 2 | 54 (32.0) | 43 (25.0) | 7 (−2.6, 16.5) | 0.1548 |
| Week 4 | 69 (40.8) | 63 (36.6) | 4.2 (−6.1, 14.5) | 0.4259 |
| Week 6 | 95 (56.2) | 70 (40.7) | 15.5 (5.0, 26.0) | 0.0042 |
| Week 13 | 103 (60.9) | 81 (47.1) | 13.9 (3.4, 24.3) | 0.0103 |
| Week 26 | 101 (59.8) | 85 (49.4) | 10.3 (−0.2, 20.9) | 0.0551 |
| Week 39 | 97 (57.4) | 81 (47.1) | 10.3 (−0.2, 20.8) | 0.0569 |
| Week 52 | 103 (60.9) | 82 (47.7) | 13.3 (2.8, 23.8) | 0.0139 |
| CGIC respondersc | ||||
| Week 2 | 56 (33.1) | 44 (25.6) | 7.6 (−2.1, 17.2) | 0.1255 |
| Week 4 | 73 (43.2) | 61 (35.5) | 7.7 (−2.6, 18.1) | 0.1439 |
| Week 6 | 90 (53.3) | 67 (39.0) | 14.3 (3.8, 24.8) | 0.0081 |
| Week 13 | 104 (61.5) | 74 (43.0) | 18.5 (8.1, 28.9) | 0.0006 |
| Week 26 | 106 (62.7) | 83 (48.3) | 14.5 (4.0, 24.9) | 0.0072 |
| Week 39 | 101 (59.8) | 82 (47.7) | 12.1 (1.6, 22.6) | 0.0252 |
| Week 52 | 107 (63.3) | 82 (47.7) | 15.6 (5.2, 26.1) | 0.0037 |
a
Wald CI is reported.
b
P value is based on the difference-in-proportions Z test. Analyses were not alpha-controlled.
c
Responders included “very much improved” and “much improved” categories.
CGIC indicates Clinical Global Impression of Change; CI, confidence interval; PGIC, Patient Global Impression of Change.