Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
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 14% of the time (493 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 2013-05-31, after 2008-11-30 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 2013-05-31. 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.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: doublestrokeatrialblindfibrillation
Phrases that lowered it: moderateand safetyefficacy andgroupindividuals -
Accepts healthy volunteers: No (raises risk) · Who can join
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Primary purpose: prevention (lowers risk) · Design
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Minimum age: 21 (lowers risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Sponsor's past termination rate: 6.3% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 12.0% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 22 (lowers risk) · Sponsor's track record
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Number of arms: 3 (lowers risk) · Design
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Sponsor's past trials: 63 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 85.9% (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 3164 (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.
The trial
Design
- Phase
- 3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 63 (typical: 32)
- Sponsor's past termination rate
- 6.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 22 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 13269 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3164 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, neurology
- Drugs matched to FDA substances
- edoxaban, warfarin
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
- Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF) NCT02072434 · started 2014 · scored riskier than 42% of active trials completed
- Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation NCT02942576 · started 2017 · scored riskier than 44% of active trials completed
- A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke NCT05643573 · started 2022 · scored riskier than 54% of active trials terminated
- Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin NCT00742859 · started 2008 · scored riskier than 54% of active trials completed
- Resolution of Left Atrial-Appendage Thrombus - Effects of Dabigatran in Patients With AF NCT02256683 · started 2014 · scored riskier than 61% of active trials terminated
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.