Trial of Roflumilast in Asthma Management (TRIM)
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 21% of the time (143 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-07-30, after 2018-08-03 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 2021-07-30. 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) (lowers risk) · Wording
Phrases that raised it: greaterpatientuncontrolledtrial oftherapy
Phrases that lowered it: asthmadisorderbmismokingparticipant -
Sponsor's past termination rate: 14.8% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Sponsor's past trials: 547 (raises risk) · Sponsor's track record
-
Blinding: quadruple (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 149 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 10.2% (lowers risk) · Drug's FDA history
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Collaborators: 2 (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 67.8% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (lowers risk) · Who can join
-
Minimum age: 18 (raises risk) · Who can join
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Disease area, neurology: No (lowers risk) · Disease area
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Disease area, respiratory: Yes (raises risk) · Disease area
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (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
- 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
- 547 (typical: 32)
- Sponsor's past termination rate
- 14.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 149 (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
- 3297 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 399 (typical: 412.5)
- Drug's FAERS reports marked serious
- 67.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory, metabolic, immunology
- Drugs matched to FDA substances
- roflumilast
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
- Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma NCT04108377 · started 2019 · scored riskier than 9% of active trials terminated
- Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics NCT00634036 · started 2009 · scored riskier than 33% of active trials completed
- Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics (Glitz Asthma) NCT00787644 · started 2009 · scored riskier than 45% of active trials terminated
- MitoQ for the Treatment of Metabolic Dysfunction in Asthma NCT04026711 · started 2020 · scored riskier than 9% of active trials completed
- Assessment of the Efficacy and Safety of FlutiForm® pMDI 125/5 µg (2 Puffs Bid) Versus Symbicort® Turbohaler® 200/6 µg (2 Puffs Bid) in Adolescent and Adult Subjects With Moderate to Severe Persistent, Reversible Asthma NCT01099722 · started 2010 · scored riskier than 12% 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.