Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD
Model scores of the 29,894 trials active now.
Model score 6% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (528 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-11-25, after 2017-03-27 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 2017-11-25. 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) (lowers risk) · Wording
Phrases that raised it: subject hassubjects within subjectssubject isdisease
Phrases that lowered it: once dailysmokingcopdcomparelung -
Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports marked serious: 40.6% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Minimum age: 40 (lowers risk) · Who can join
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Drug's FAERS reports with a death: 7.0% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past termination rate: 4.8% (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 90213 (lowers risk) · Drug's FDA history
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Blinding: quadruple (lowers risk) · Design
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Maximum age: not given (lowers risk) · Who can join
-
Drug's FAERS reports in the prior 12 months: 13306 (lowers 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
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 40 (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
- 21 (typical: 32)
- Sponsor's past termination rate
- 4.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 13 (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
- 90213 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 13306 (typical: 412.5)
- Drug's FAERS reports marked serious
- 40.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory
- Drugs matched to FDA substances
- revefenacin, tiotropium
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
- A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD NCT03573817 · started 2018 · scored riskier than 4% of active trials completed
- Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients NCT01969721 · started 2013 · scored riskier than 3% of active trials completed
- Revefenacin in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease(COPD) NCT05046795 · started 2021 · scored riskier than 6% of active trials completed
- Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness NCT03137992 · started 2017 · scored riskier than 2% of active trials completed
- A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD) NCT01706328 · started 2012 · scored riskier than 4% 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.