A Bioequivalence Study Of AG-013736 Tablets Under Fed Conditions In Healthy Volunteers
Model scores of the 29,894 trials active now.
Model score 2% 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 on 2010-02-28, after 2010-01-31 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 2010-02-28. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: kidneyivheartevidence ofdisease
Phrases that lowered it: healthytabletkgbioequivalencebody -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 15.6% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Primary purpose: not given (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 385 (raises risk) · Sponsor's track record
-
Minimum age: 21 (lowers risk) · Who can join
-
Drug's FAERS reports with a death: 31.6% (raises risk) · Drug's FDA history
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Blinding: none (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor's past trials: 674 (raises risk) · Sponsor's track record
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Responsible party: not given (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Maximum age: 47 (lowers risk) · Who can join
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Disease area, neurology: No (lowers 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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- not given (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- 47 (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
- 674 (typical: 32)
- Sponsor's past termination rate
- 15.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 385 (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
- 19 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 18 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 31.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- axitinib
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
- Food Effect Study Of AG-013736 In Healthy Volunteers NCT00918632 · started 2009 · scored riskier than 2% of active trials completed
- Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy Adults NCT03397329 · started 2017 · scored riskier than 0% of active trials completed
- A Bioequivalence Study Of AG-013736 Tablets In Healthy Volunteers NCT00905814 · started 2009 · scored riskier than 2% of active trials completed
- Clinical Trial to Evaluate the Bioavailability and Safety of AGSAV301 NCT01536353 · started 2012 · scored riskier than 0% of active trials completed
- Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet NCT01256151 · started 2011 · 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.