Baseline Burden of Endometriosis-Associated Pain among Women in Two Phase 3 Elagolix Studies [10Q]
Bibliographic record
Abstract
INTRODUCTION: Few data exist on the extent of symptoms in women with endometriosis. This analysis examined baseline pain burden among women with moderate to severe endometriosis pain in two phase 3 studies of elagolix (an oral, non-peptide GnRH antagonist) for the management of endometriosis-associated pain. METHODS: Elaris EM-I and Elaris EM-II were two double-blind, randomized, 6-month, placebo-controlled phase 3 studies evaluating two elagolix doses (150 mg once daily and 200 mg twice daily) in women with endometriosis-associated pain. This analysis included randomized women pooled across studies and treatment groups. Dysmenorrhea (DYS) and non-menstrual pelvic pain (NMPP) scores were recorded in a daily electronic-diary and characterized as ‘none’, ‘mild’, ‘moderate’, and ‘severe’, with definitions that incorporated daily functioning. Days with DYS or NMPP and severity of pain are summarized. Baseline was defined as the average of the last 35 days during the screening period. RESULTS: At baseline, the mean [SD] number of days women reported DYS and NMPP was 8.0 [3.0] days (97.6% of menstruating days) and 20.5 days [5.4] (90.3% of non-menstruating days), respectively (N=1686 for the combined studies). Enrolled women reported moderate/severe DYS and NMPP most days during the baseline phase (mean [SD]: DYS, 80.5% [21.2] of menstruating days; NMPP, 57% [29.0] of non-menstruating days). CONCLUSION: On average in these two phase 3 studies, women with endometriosis-associated pain experienced DYS or NMPP > 90% of days during the baseline phase and moderate/severe pain was reported for a majority of the days when pain was reported.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.015 | 0.012 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.006 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".