RIvoraxaban in Mitral Stenosis
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (381 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-08-14, after 2019-05-22 start.
Reason given by the sponsor: “enrollment”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2021-08-14. 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: mrimsimagingleftmitral
Phrases that lowered it: participantspatientsefficacyconsent formgroup -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 13.8% (lowers risk) · Drug's FDA history
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Blinding: single (lowers risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
-
Collaborators: 2 (lowers risk) · Design
-
Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports before start: 262866 (lowers risk) · Drug's FDA history
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
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Maximum age: 75 (lowers risk) · Who can join
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 262866 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 39404 (typical: 412.5)
- Drug's FAERS reports marked serious
- 82.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, infectious disease
- Drugs matched to FDA substances
- rivaroxaban, 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
- RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial NCT02303795 · started 2015 · scored riskier than 77% of active trials completed
- INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Non-Inferiority NCT02832544 · started 2016 · scored riskier than 56% of active trials completed
- A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy NCT01729871 · started 2013 · scored riskier than 22% of active trials completed
- Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve. NCT02128841 · started 2012 · scored riskier than 72% of active trials terminated
- A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention NCT01830543 · started 2013 · scored riskier than 63% 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.