The Use of Intranasal Fentanyl for the Treatment of Incident Dyspnea in Congestive Heart Failure: A Prospective Trial
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (446 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-09-15, after 2015-10-31 start.
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 2017-09-15. 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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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patients mustheart failuredyspneacongestiveprimary
Phrases that lowered it: investigatecriteria patientsadministrationperiodpatients who -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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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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Design: single group (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: 23.9% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Blinding: none (raises risk) · Design
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Drug's FAERS reports marked serious: 76.0% (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
-
Has a data monitoring committee: No (lowers risk) · Design
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Collaborators: 0 (raises 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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (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
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 36908 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 9877 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, respiratory
- Drugs matched to FDA substances
- fentanyl
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
- Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea NCT01832402 · started 2013 · scored riskier than 97% of active trials completed
- Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea NCT01856114 · started 2014 · scored riskier than 96% of active trials completed
- Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea NCT02597478 · started 2016 · scored riskier than 97% of active trials completed
- Effect of Sublingual Fentanyl on Breathlessness in COPD NCT04004117 · started 2019 · scored riskier than 17% of active trials terminated
- Breakthrough Dyspnea Fentanyl Study in Cancer Patients NCT01515566 · started 2012 · scored riskier than 85% 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.