Table 4.
Responder Rates for Primary Effectiveness End Points (Evaluable Population)
| End Point | Visit | Result | 95% CI |
|---|---|---|---|
| PR-SMFRS ≥1-grade improvement, n/N (%) | 1 | 27/53 (50.9) | 36.8, 64.9 |
| 2 | 14/22 (63.6) | 40.7, 82.8 | |
| 3 | 6/7 (85.7) | 42.1, 99.6 | |
| 4 | 0/1 (0.0) | NA* | |
| EOT | 54/72 (75.0) | 63.4, 85.4 | |
| SMSLG ≥1-grade improvement, n/N (%) | 1 | 17/52 (32.7) | 20.3, 47.1 |
| 2 | 11/22 (50.0) | 28.2, 71.8 | |
| 3 | 4/7 (57.1) | 18.4, 90.1 | |
| 4 | 0/1 (0.0) | NA* | |
| EOT | 30/72 (41.7) | 30.2, 53.9 | |
| SSRS ≥1-grade improvement, n/N (%) | 1 | 37/53 (69.8) | 55.7, 81.7 |
| 2 | 18/22 (81.8) | 59.7, 94.8 | |
| 3 | 7/7 (100.0) | 59.0, 100.0 | |
| 4 | 0/1 (0.0) | NA* | |
| EOT | 64/73 (87.7) | 77.9, 94.2 | |
| PGQ responder rate for fat under chin, n/N (%) | EOT | ||
| A great deal better | 27/77 (35.1) | ||
| Moderately better | 28/77 (36.4) | ||
| PGQ responder rate for definition between chin and neck, n/N (%) | EOT | ||
| A great deal better | 25/77 (32.5) | ||
| Moderately better | 29/77 (37.7) | ||
| PGQ responder rate for satisfaction with treatment, n/N (%) | EOT | ||
| Extremely satisfied | 35/77 (45.5) | ||
| Moderately satisfied | 23/77 (29.9) |
*
No CIs available because n/N = 0/1.