Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap
Model scores of the 29,894 trials active now.
Model score 8% for any early termination, 1% 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.
How it ended
Completed on 2016-05-04, after 2014-05-15 start.
The score above never used this outcome: 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.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2016-05-04. 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.
What moved the score
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: dlbleedingin subjectsplacebo controlledsubjects with
Phrases that lowered it: visitand safetythe efficacyscreeningefficacy and -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 6.5% (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Blinding: quadruple (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 100 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Maximum age: 50 (lowers risk) · Who can join
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Number of arms: 5 (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Disease area, neurology: No (lowers risk) · Disease area
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Sponsor's past trials: 511 (lowers risk) · Sponsor's track record
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Responsible party: sponsor (lowers risk) · Design
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.
The trial
Design
- Phase
- 2
- Number of arms
- 5 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 50 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 511 (typical: 32)
- Sponsor's past termination rate
- 6.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 100 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- none matched
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids NCT02465814 · started 2015 · scored riskier than 12% of active trials completed
- Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids NCT01452659 · started 2011 · scored riskier than 17% of active trials completed
- A Study to Test Whether Study Drug BAY1128688 Brings Pain Relief to Women With Endometriosis and if so to Get a First Idea Which Dose(s) Work Best NCT03373422 · started 2017 · scored riskier than 17% of active trials terminated
- Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670 NCT01816815 · started 2011 · scored riskier than 2% of active trials completed
- Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids NCT03070899 · started 2017 · scored riskier than 14% 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.