Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,198 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-02-07, after 2020-01-07 start.
Reason given by the sponsor: “enrollment”
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 2022-02-07. 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
-
Sponsor's past termination rate: 19.0% (raises risk) · Sponsor's track record
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Design: factorial (lowers risk) · Design
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Phase: 2 (raises risk) · Design
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Drug's FAERS reports marked serious: 36.1% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 31 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports with a death: 2.4% (lowers risk) · Drug's FDA history
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Number of arms: 4 (lowers risk) · Design
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Blinding: none (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 6702 (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 123766 (lowers 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
- 2
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- factorial (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 7 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 121 (typical: 32)
- Sponsor's past termination rate
- 19.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 31 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 123766 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6702 (typical: 412.5)
- Drug's FAERS reports marked serious
- 36.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- nicotine, 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
- STARS (Smoking Treatment And Remote Sampling) Study NCT04525755 · started 2021 · scored riskier than 22% of active trials completed
- Combination of Nicotine Replacement Therapy (NRT) and Varenicline to Increase Cessation of Tobacco (CONVICT Study) NCT01184664 · started 2011 · scored riskier than 7% of active trials completed
- EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking NCT03262662 · started 2017 · scored riskier than 6% of active trials completed
- Study to Determine if a New Nicotine Replacement Therapy Can Safely Help Smokers to Quit Smoking NCT01296698 · started 2011 · scored riskier than 16% of active trials terminated
- Quit Smoking Study for People Who Use E-Cigarettes NCT04946825 · started 2021 · scored riskier than 6% 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.