Table 1.
Baseline characteristics of patients in analysis (modified intent-to-treat)a
| Characteristic | N | Placebo | N | Elagolix 150 mg QD | N | Elagolix 200 mg BID |
|---|---|---|---|---|---|---|
| Age, years, mean ± SD | 556 | 32.7 ± 6.5 | 359 | 32.4 ± 6.4 | 355 | 32.4 ± 6.6 |
| BMI, kg/m2, mean ± SD | 553 | 27.5 ± 6.1 | 358 | 27.7 ± 6.6 | 351 | 27.3 ± 6.4 |
|
Dysmenorrhea score, mean ± SD (scale 0–3)b |
556 | 2.1 ± 0.5 | 359 | 2.1 ± 0.5 | 355 | 2.1 ± 0.5 |
| Nonmenstrual pelvic pain score, mean ± SD (scale 0–3)b | 556 | 1.6 ± 0.5 | 359 | 1.6 ± 0.5 | 355 | 1.5 ± 0.5 |
| Dyspareunia score, mean ± SD (scale 0–3, or N/A)c | 456 | 1.5 ± 0.8 | 294 | 1.5 ± 0.9 | 289 | 1.5 ± 0.9 |
| Hours of scheduled employment-based work in previous week, LS mean ± SE | 556 | 33.0 ± 0.5 | 359 | 34.2 ± 0.7 | 355 | 33.0 ± 0.7 |
| Hours of workplace productivity lost, LS mean ± SE | ||||||
| Total hours lost | 556 | 15.7 ± 0.5 | 359 | 16.2 ± 0.6 | 355 | 16.0 ± 0.6 |
| Absenteeism | 556 | 3.2 ± 0.2 | 359 | 3.0 ± 0.3 | 355 | 3.0 ± 0.3 |
| Presenteeism | 552 | 12.6 ± 0.4 | 356 | 13.4 ± 0.5 | 350 | 13.2 ± 0.5 |
| Percentage of workplace productivity lost, LS mean ± SE | ||||||
| Total percentage of hours lost | 556 | 44.0 ± 1.2 | 359 | 44.5 ± 1.4 | 355 | 45.3 ± 1.5 |
| Absenteeism | 556 | 9.8 ± 0.7 | 359 | 8.3 ± 0.9 | 355 | 9.6 ± 0.9 |
| Presenteeism | 552 | 34.4 ± 1.0 | 356 | 36.6 ± 1.2 | 350 | 36.3 ± 1.3 |
| Hours of planned household work in previous week, LS mean ± SE | 681 | 7.7 ± 0.3 | 437 | 8.1 ± 0.4 | 447 | 7.9 ± 0.4 |
| Hours of household productivity lost, LS mean ± SE | ||||||
| Total hours lost | 681 | 8.3 ± 0.3 | 437 | 8.6 ± 0.4 | 447 | 8.1 ± 0.4 |
| Absenteeism | 681 | 4.7 ± 0.2 | 437 | 4.8 ± 0.3 | 447 | 4.7 ± 0.3 |
| Presenteeism | 679 | 3.6 ± 0.2 | 435 | 3.8 ± 0.2 | 443 | 3.4 ± 0.2 |
| Percentage of household productivity lost, LS mean ± SE | ||||||
| Total percentage of hours lost | 681 | 65.6 ± 1.1 | 437 | 63.4 ± 1.4 | 447 | 64.4 ± 1.4 |
| Absenteeism | 681 | 39.1 ± 1.1 | 437 | 37.4 ± 1.4 | 447 | 38.7 ± 1.4 |
| Presenteeism | 679 | 26.6 ± 0.7 | 435 | 26.2 ± 0.9 | 443 | 25.9 ± 0.9 |
aWomen employed full- or part-time with scheduled work hours in the week prior to taking the survey were included in workplace productivity analyses (n = 1270); women with planned household work hours in the week prior to taking the survey, regardless of employment status, were included in household productivity analyses (n = 1565)
bPain responses were none = 0, mild = 1, moderate = 2, and severe = 3; group mean is based on the daily average score over the 35-day interval
cPain responses were none = 0, mild = 1, moderate = 2, severe = 3, and not applicable; group mean is based on the daily average score over the 35-day interval. Subjects responding ‘not applicable’ for the entire 35-day interval are excluded for a total of 1384 subjects with baseline dyspareunia pain responses
BID twice daily, BMI body mass index, LS least squares, N/A not applicable, QD once daily, SD standard deviation, SE standard error