Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 4% 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
Terminated on 2011-09-30, after 2010-07-31 start.
Reason given by the sponsor: “safety”
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 2011-09-30. 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: heartstrokepatientfailuremyocardial
Phrases that lowered it: the efficacycardiovascularagedperiodparallel -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports with a death: 5.6% (lowers risk) · Drug's FDA history
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Blinding: triple (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Sponsor's past termination rate: 12.7% (raises risk) · Sponsor's track record
-
Minimum age: 65 (lowers risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 173 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: 97.3% (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Responsible party: sponsor (lowers risk) · Design
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Drug's FAERS reports in the prior 12 months: 692 (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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 65 (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
- 496 (typical: 32)
- Sponsor's past termination rate
- 12.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 173 (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
- 692 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 692 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- dronedarone
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
- Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation NCT01213368 · started 2010 · scored riskier than 53% of active trials completed
- Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation NCT01522651 · started 2012 · scored riskier than 47% of active trials completed
- Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF) NCT02072434 · started 2014 · scored riskier than 42% of active trials completed
- Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes NCT02618577 · started 2016 · scored riskier than 44% of active trials terminated
- A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation NCT04582409 · started 2020 · scored riskier than 78% 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.