A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Solution And A Varenicline Patch Applied To The Skin
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 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 2008-12-31, after 2008-12-31 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 2008-12-31. 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: the skintolerabilityphasedose studymedical
Phrases that lowered it: healthythe pharmacokineticssmokerssingle dosepharmacokinetics of -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 15.1% (raises risk) · Sponsor's track record
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Primary purpose: not given (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 303 (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports in the prior 12 months: 5864 (raises risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Sponsor's past trials: 485 (raises risk) · Sponsor's track record
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Responsible party: not given (raises risk) · Design
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Drug's FAERS reports before start: 8835 (raises risk) · Drug's FDA history
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Drug's FAERS reports with a death: 2.9% (lowers risk) · Drug's FDA history
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Maximum age: 55 (lowers risk) · Who can join
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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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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 89.1% (raises risk) · Drug's FDA history
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Disease area, psychiatry: 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
- non randomized (typical: randomized)
- Design
- 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
- 18
- Maximum age
- 55 (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
- 485 (typical: 32)
- Sponsor's past termination rate
- 15.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 303 (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
- 8835 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5864 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- base, varenicline
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
- A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Patch Applied To The Skin NCT01013454 · started 2009 · scored riskier than 4% of active trials completed
- A Study Evaluating the Absorption Of Varenicline Through The Skin Following Once Daily Application Of A Patch For 14 Days NCT01234142 · started 2010 · scored riskier than 10% of active trials completed
- A Single Dose Study Investigating the Absorption and Elimination as Well as the Tolerability of Varenicline Transdermal Delivery System (e.g., a Patch) as Compared to Oral Varenicline in Adult Smokers. NCT00661765 · started 2008 · scored riskier than 1% of active trials completed
- An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation NCT00731562 · started 2008 · scored riskier than 1% of active trials completed
- Nicotine Patch Bioequivalence Study NCT01658202 · started 2012 · 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.