Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2015-12-31. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cancerbleedingwomenassociateduncontrolled
  Phrases that lowered it: type diabetesefficacysafety18 toscreening
• Disease area, cancer: Yes (raises risk) · Disease area
• Number of arms: 8 (lowers risk) · Design
• Phase: 2 (raises risk) · Design
• Design: parallel (raises risk) · Design
• Blinding: quadruple (lowers risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: 2.4% (lowers risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: 64.7% (raises risk) · Drug's FDA history
• Sponsor's past trials: 17 (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Drug's FAERS reports before start: 20043 (raises risk) · Drug's FDA history

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

• Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study) NCT02691494 · started 2016 · scored riskier than 14% of active trials completed
• Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women NCT02654054 · started 2015 · scored riskier than 12% of active trials completed
• Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women NCT03271489 · started 2017 · scored riskier than 10% of active trials completed
• Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids NCT01441635 · started 2011 · scored riskier than 11% of active trials completed
• An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids NCT02925494 · started 2016 · scored riskier than 16% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.