Table 6.
Faceseal Leakage (FSL) and change in weight by visit.
| Visit 2 (Month 6) | |||||||
|---|---|---|---|---|---|---|---|
| Acceptable Fit |
Unacceptable Fit |
||||||
| n | Mean | SD | n | Mean | SD | ||
| Weight V1 (lb) | 168 | 181 | 41 | Weight V1 (lb) | 27 | 194 | 44 |
| Δ Weight (V2-V1) (lb) | 167 | 3 | 10 | Δ Weight (V2-V1) (lb) | 27 | −2 | 13 |
| n | GM | GSD | n | GM | GSD | ||
| FSL V1 (%) | 168 | 0.6%a | 2.1 | FSL V1 (%) | 27 | 0.9%a | 2.0 |
| FSL V2 (%) | 168 | 0.6%b | 2.2 | FSL V2 (%) | 27 | 2.5%b | 2.9 |
| Visit 3 (Month 12) | |||||||
| Acceptable Fit |
Unacceptable Fit |
||||||
| |
n |
Mean |
SD |
|
n |
Mean |
SD |
| Weight V1 (lb) | 164 | 180 | 40 | Weight V1 (lb) | 19 | 206 | 54 |
| Δ Weight (V3-V1) (lb) | 163 | 0 | 13 | Δ Weight (V3-V1) (lb) | 19 | −8 | 23 |
| n | GM | GSD | n | GM | GSD | ||
| FSL V1 (%) | 164 | 0.6%a | 2.2 | FSL V1 (%) | 19 | 0.8%a | 2.1 |
| FSL V3 (%) | 164 | 0.6%b | 2.2 | FSL V3 (%) | 19 | 2.2%b | 3.4 |
| Visit 4 (Month 18) | |||||||
| Acceptable Fit |
Unacceptable Fit |
||||||
| |
n |
Mean |
SD |
|
n |
Mean |
SD |
| Weight V1 (lb) | 161 | 181 | 41 | Weight V1 (lb) | 12 | 213 | 58 |
| Δ Weight (V4-V1) (lb) | 160 | −2 | 14 | Δ Weight (V4-V1) (lb) | 12 | −11 | 32 |
| n | GM | GSD | n | GM | GSD | ||
| FSL V1 (%) | 161 | 0.6%a | 2.2 | FSL V1 (%) | 12 | 0.9%a | 1.9 |
| FSL V4 (%) | 161 | 0.6%b | 2.3 | FSL V4 (%) | 12 | 2.6%b | 2.6 |
| Visit 5 (Month 24) | |||||||
| Acceptable Fit |
Unacceptable Fit |
||||||
| |
n |
Mean |
SD |
|
n |
Mean |
SD |
| Weight V1 (lb) | 143 | 182 | 42 | Weight V1 (lb) | 20 | 183 | 52 |
| Δ Weight (V5-V1) (lb) | 143 | −2 | 15 | Δ Weight (V5-V1) (lb) | 20 | −6 | 16 |
| n | GM | GSD | n | GM | GSD | ||
| FSL V1 (%) | 143 | 0.5%a | 2.2 | FSL V1 (%) | 20 | 1.0%a | 2.1 |
| FSL V5 (%) | 143 | 0.6%b | 2.6 | FSL V5 (%) | 20 | 2.2%b | 2.5 |
| Visit 6 (Month 30) | |||||||
| Acceptable Fit |
Unacceptable Fit |
||||||
| |
n |
Mean |
SD |
|
n |
Mean |
SD |
| Weight V1 (lb) | 131 | 182 | 43 | Weight V1 (lb) | 23 | 179 | 46 |
| Δ Weight (V6-V1) (lb) | 131 | 0 | 16 | Δ Weight (V6-V1) (lb) | 22 | −13 | 38 |
| n | GM | GSD | n | GM | GSD | ||
| FSL V1 (%) | 131 | 0.5%a | 2.2 | FSL V1 (%) | 23 | 0.8%a | 2.3 |
| FSL V6 (%) | 131 | 0.6%b | 2.0 | FSL V6 (%) | 23 | 2.8%b | 2.8 |
| Visit 7 (Month 36) | |||||||
| Acceptable Fit |
Unacceptable Fit |
||||||
| |
n |
Mean |
SD |
|
n |
Mean |
SD |
| Weight V1 (lb) | 113 | 179 | 39 | Weight V1 (lb) | 21 | 204 | 62 |
| Δ Weight (V7-V1) (lb) | 113 | 2 | 16 | Δ Weight (V7-V1) (lb) | 20 | −11 | 27 |
| n | GM | GSD | n | GM | GSD | ||
| FSL V1 (%) | 113 | 0.5%a | 2.2 | FSL V1 (%) | 21 | 0.8%a | 2.2 |
| FSL V7 (%) | 113 | 0.6%b | 2.1 | FSL V7 (%) | 21 | 2.4%b | 2.7 |
Notes:
aindicates GM FSL values are statistically significant between fit acceptability categories for subjects on Visit 1.
bindicates GM FSL values are statistically significant between fit acceptability categories for subjects on the indicated visit.
n indicates the number of subjects which have data on the indicated visit.
Weight data is missing for one test subject for Visits 2, 3, and 4 who, due to a medical condition, was unable to step onto the scale for these visits; however, weight data was available for this subject on Visit 1. Thus for Visits 2, 3, and 4 for subjects with acceptable fit, the “Δ Weight” category has one fewer subject than the “Weight V1” category.