Study the Effect of Avanafil on the Pharmacodynamics and Pharmacokinetics of Warfarin in Healthy Male Subjects
Model scores of the 29,894 trials active now.
Model score 4% 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 7% of the time (289 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 2010-05-31, after 2010-04-30 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 2010-05-31. 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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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: placebocontrolleddouble blindeffectspressure
Phrases that lowered it: healthythe pharmacokineticsmalescreeningsubjects -
Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 4.2% (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Minimum age: 21 (lowers risk) · Who can join
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Responsible party: not given (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 21 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers 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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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Blinding: double (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Maximum age: 45 (lowers risk) · Who can join
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Sponsor's past trials: 24 (lowers risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 0 (raises risk) · Drug's FDA history
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
- treatment
- Blinding
- double (typical: 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
- 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
- 24 (typical: 32)
- Sponsor's past termination rate
- 4.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 21 (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
- psychiatry, urogenital
- Drugs matched to FDA substances
- avanafil
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
- Assess the Effect of Food on Avanafil Pharmacokinetic (PK), to Compare 2 Oral Formulations of Avanafil,and Investigate Dose Proportionality in Healthy Male Subjects NCT01095601 · started 2010 · scored riskier than 0% of active trials completed
- A Phase I Crossover Study of the Hemodynamic Interactions of Avanafil & Alcohol in Healthy Male Subjects. NCT01054859 · started 2010 · scored riskier than 4% of active trials completed
- To Evaluate The Effect Of Ketoconazole, Ritonavir and Erythromycin on the Safety and Pharmacokinetics of Avanafil NCT00770042 · started 2008 · scored riskier than 2% of active trials completed
- Drug Interaction Study of Avanafil and Enalapril or Amlodipine NCT01117038 · started 2010 · scored riskier than 1% of active trials completed
- Study to Assess Pharmacokinetic Drug-Drug Interaction Between Avatrombopag When Co-Administered With Fluconazole, Itraconazole, or Rifampin in Healthy Subjects NCT02809768 · started 2016 · scored riskier than 3% 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.