To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers
Model scores of the 29,894 trials active now.
Model score 5% for any early termination, 0% 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 (776 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-03-29, after 2018-03-01 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 2018-03-29. 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: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: riskevidenceulndiseasemg dl
Phrases that lowered it: healthybodykgvolunteerssingle dose -
Sponsor's past trials: 2474 (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Minimum age: 21 (lowers risk) · Who can join
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Has a data monitoring committee: not given (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 14.4% (lowers risk) · Drug's FDA history
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Sponsor's past termination rate: 6.3% (lowers risk) · Sponsor's track record
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Drug's FAERS reports before start: 460799 (lowers risk) · Drug's FDA history
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Blinding: none (lowers risk) · Design
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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: 206 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 69.5% (lowers risk) · Drug's FDA history
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Maximum age: 45 (lowers risk) · Who can join
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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- 45 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 2474 (typical: 32)
- Sponsor's past termination rate
- 6.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 206 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 5 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 460799 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 82429 (typical: 412.5)
- Drug's FAERS reports marked serious
- 69.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, respiratory
- Drugs matched to FDA substances
- acetaminophen, acetaminophen dextromethorphan phenylephrine, cold, dextromethorphan, phenylephrine
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
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- Bioequivalence Study of Esomeprazole 20 Milligram (mg) Delayed-Release Capsules in Healthy Adult Participants NCT05265247 · started 2022 · scored riskier than 2% of active trials completed
- A Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance and Metabolism of PF-07265803 NCT05286281 · started 2022 · scored riskier than 7% of active trials completed
- Evaluate the Effects of Famotidine or Rabeprazole on the PK of Nirogacestat NCT07171619 · started 2025 · scored riskier than 2% of active trials completed
- Excretion Balance, Pharmacokinetics, and Metabolism Following of [14C]-Venglustat Administration in Healthy Male Subjects NCT05238714 · started 2020 · scored riskier than 2% 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.