Table 2.
Mean Absolute and Percent Change From Baseline in Menstrual Blood Loss Over Time by Treatment Group and Nonresponder Classification
| Met both MBL criteria but discontinued prematurely |
Met 1 MBL criterion |
Met neither MBL criterion |
All nonresponders |
|||||
|---|---|---|---|---|---|---|---|---|
| Placebo | Elagolix+add-back therapy | Placebo | Elagolix+add-back therapy | Placebo | Elagolix +add-back therapy | Placebo | Elagolix+add-back therapy | |
| Baseline | n = 4 | n = 17 | n = 17 | n = 23 | n = 145 | n = 49 | n = 166 | n = 89 |
| Mean (mL) | 227.1 ± 161.4 | 238.8 ± 176.8 | 258.2 ± 183.4 | 328.9 ± 173.8 | 264.3 ± 181.6 | 253.7 ± 168.6 | 262.8 ± 180.4 | 270.3 ± 173.2 |
| Change from baseline | ||||||||
| 1 month | n = 3 | n = 13 | n = 17 | n = 21 | n = 141 | n = 45 | n = 161 | n = 79 |
| Change (mL) | –66.3 ± 50.4 | –183.1 ± 23.5 | –95.3 ± 38.3 | –59.0 ± 34.3 | –11.0 ± 14.4 | –49.7 ± 25.8 | –19.1 ± 13.3 | –79.5 ± 19.0 |
| Change (%) | –39.2 ± 20.5 | –80.3 ± 9.6 | –25.1 ± 10.8 | –16.1 ± 9.7 | –5.6 ± 4.8 | –14.8 ± 8.7 | –8.0 ± 4.4 | –26.2 ± 6.2 |
| 3 months | — | n = 6 | n = 16 | n = 18 | n = 128 | n = 33 | n = 144 | n = 57 |
| Change (mL) | –280.8 ± 6.6 | –80.7 ± 30.7 | –210.0 ± 28.6 | –0.8 ± 13.1 | –90.8 ± 26.0 | –7.1 ± 12.9 | –157.8 ± 20.7 | |
| Change (%) | –86.2 ± 5.1 | –28.7 ± 9.4 | –72.9 ± 8.7 | –2.8 ± 4.3 | –41.3 ± 8.6 | –5.5 ± 4.0 | –57.0 ± 6.3 | |
| 6 months | — | — | n = 13 | n = 16 | n = 110 | n = 19 | n = 123 | n = 35 |
| Change (mL) | –138.4 ± 17.8 | –180.5 ± 16.1 | 24.4 ± 17.2 | 12.0 ± 41.4 | 9.4 ± 16.0 | –77.0 ± 30.2 | ||
| Change (%) | –43.9 ± 6.9 | –62.7 ± 6.3 | 13.0 ± 6.2 | 1.1 ± 14.9 | 7.2 ± 5.7 | –27.2 ± 10.7 | ||
Baseline values are expressed as mean ± SD. Changes from baseline are presented as LS mean ± SE or mean percent ± SE obtained from an analysis of covariance model with treatment and study as the main effects and baseline MBL volume as a covariate.
LS, least-squares; MBL, menstrual blood loss.