Safety and Efficacy of Bosentan in Patients With Diastolic Heart Failure and Secondary Pulmonary Hypertension
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 9% 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 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 2014-06-30, after 2009-01-31 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 2014-06-30. 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: heartfractionejectioncancerlung
Phrases that lowered it: with normalmmhgrelevantml30 -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports with a death: 30.0% (raises risk) · Drug's FDA history
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Phase: 3 (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Responsible party: principal investigator (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Maximum age: 75 (lowers risk) · Who can join
-
Number of arms: 2 (raises risk) · Design
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Disease area, respiratory: Yes (raises risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Drug's FAERS reports marked serious: 86.3% (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
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 4 (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
- 0 (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
- 2480 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 456 (typical: 412.5)
- Drug's FAERS reports marked serious
- 86.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 30.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, respiratory
- Drugs matched to FDA substances
- bosentan
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
- Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure (The RELAX Study) NCT00763867 · started 2008 · scored riskier than 84% of active trials completed
- Inhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial NCT02885636 · started 2016 · scored riskier than 84% of active trials completed
- Impact of Multiple Doses of BAY63-2521 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Interstitial Lung Disease (ILD) Associated Pulmonary Hypertension (PH) NCT00694850 · started 2008 · scored riskier than 57% of active trials completed
- Sildenafil in HFpEF (Heart Failure With Preserved Ejection Fraction) and PH NCT01726049 · started 2011 · scored riskier than 56% of active trials completed
- The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART) NCT06062966 · started 2024 · scored riskier than 79% 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.