A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 3% 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 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 2017-02-28, after 2014-09-30 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 2017-02-28. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 5% (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: the subjectsubjectstransplanttransplantationmyocardial
Phrases that lowered it: trialfev1agedefficacyantibiotics -
Drug's FAERS reports with a death: 34.2% (raises risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Phase: 3 (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 94.4% (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Keywords listed: 0 (raises risk) · Design
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Number of arms: 2 (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
- 3 (typical: 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
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 99 (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
- 20 (typical: 32)
- Sponsor's past termination rate
- 5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 1949 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 211 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 34.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory, digestive
- Drugs matched to FDA substances
- mannitol
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
- Crossover Trial Determining the Efficacy of Dry Powder Mannitol to Improve Lung Function in Subjects Aged 6-17 Years NCT01883531 · started 2013 · scored riskier than 21% of active trials completed
- Long Term Administration of Inhaled Mannitol in Cystic Fibrosis NCT00630812 · started 2008 · scored riskier than 33% of active trials completed
- Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis NCT00669331 · started 2009 · scored riskier than 24% of active trials completed
- A Phase IIb Study of OligoG in Subjects With Cystic Fibrosis NCT02157922 · started 2014 · scored riskier than 10% of active trials completed
- Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients NCT00792714 · started 2008 · scored riskier than 65% 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.