Single and Multiple Oral Doses of Dabigatran Etexilate in Healthy Chinese Subjects
Model scores of the 29,894 trials active now.
Model score 6% 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 5% of the time (4,470 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.
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. 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: chronicof studylongadministrationhead
Phrases that lowered it: healthypharmacokineticsmultiplerelevant to18 and -
Has a data monitoring committee: not given (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: 4.7% (lowers risk) · Sponsor's track record
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Blinding: none (lowers risk) · Design
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Drug's FAERS reports with a death: 14.3% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 198 (lowers risk) · Sponsor's track record
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Maximum age: 45 (raises risk) · Who can join
-
Responsible party: sponsor (lowers 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
- 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
- 18
- Maximum age
- 45 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 86 (typical: 32)
- Sponsor's past termination rate
- 4.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 198 (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
- 21 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 8 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- dabigatran etexilate
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
- Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers NCT02044367 · started 2014 · scored riskier than 2% of active trials completed
- Pradaxa Tablet Proton Pump Inhibitor (PPI) Bioavailability (BA) Study in Japan NCT03143166 · started 2017 · scored riskier than 9% of active trials completed
- Bioavailability of Different Applications of Dabigatran in Healthy Volunteers NCT02171611 · started 2009 · scored riskier than 2% of active trials completed
- Bioavailability Study of Five Tablet Formulations of Dabigatran Etexilate Compared to Commercial Capsule Formulation in Healthy Male Subjects NCT02710630 · started 2016 · scored riskier than 2% of active trials completed
- Investigation of the Impact of Concomitant Use of Multiple Doses of Clopidogrel With Multiple Doses of Dabigatran Etexilate on the Pharmacokinetic and Pharmacodynamic Parameters in Healthy Male Subjects NCT02171598 · started 2009 · scored riskier than 1% 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.