Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 19% of the time (731 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 2009-01-31, after 2008-01-31 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 2009-01-31. 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: patientschronicsyndrometo randomizationpatient
Phrases that lowered it: singlesubjectsrelevantkgcontain all -
Accepts healthy volunteers: No (raises risk) · Who can join
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Has a data monitoring committee: Yes (raises risk) · Design
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Phase: 2 (raises risk) · Design
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Design: parallel (raises risk) · Design
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Responsible party: not given (raises risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Number of arms: 5 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 214 (raises risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Disease area, neurology: Yes (raises risk) · Disease area
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Sponsor's past trials: 281 (raises risk) · Sponsor's track record
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Sponsor's past termination rate: 7.8% (lowers risk) · Sponsor's track record
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Maximum age: 75 (raises risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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
- 5 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 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
- industry (typical: academic or other)
- Sponsor's past trials
- 281 (typical: 32)
- Sponsor's past termination rate
- 7.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 214 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, respiratory
- Drugs matched to FDA substances
- none matched
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
- AD109 Dose Finding in Mild to Moderate OSA NCT04631107 · started 2020 · scored riskier than 6% of active trials completed
- Trial of AD036 in Obstructive Sleep Apnea NCT03845023 · started 2019 · scored riskier than 15% of active trials completed
- Crossover Trial of AD109 in Obstructive Sleep Apnea NCT04580394 · started 2020 · scored riskier than 5% of active trials completed
- Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study) NCT05813275 · started 2023 · scored riskier than 29% of active trials completed
- Study of AD128 Versus Placebo in Obstructive Sleep Apnea NCT04449133 · started 2020 · scored riskier than 18% 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.