Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-05-31, after 2015-08-31 start.
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 2018-05-31. 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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Sponsor's past termination rate: 17.0% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Disease area, cancer: Yes (raises risk) · Disease area
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Minimum age: 35 (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: braincancerchemotherapyunstabledisease
Phrases that lowered it: nicotineparticipantsevaluate theto evaluatedrugs -
Phase: 2 (raises risk) · Design
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Drug's FAERS reports marked serious: 29.2% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 29 (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 53 (lowers risk) · Sponsor's track record
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 2.7% (lowers risk) · Drug's FDA history
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Disease area, dermatology: Yes (raises risk) · Disease area
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Responsible party: principal investigator (lowers risk) · Design
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Keywords listed: 7 (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Number of arms: 2 (raises risk) · Design
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Collaborators: 0 (raises 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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 7 (typical: 1)
Who can join
- Minimum age
- 35 (typical: 18)
- Maximum age
- 80 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 53 (typical: 32)
- Sponsor's past termination rate
- 17.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 29 (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
- 27541 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4653 (typical: 412.5)
- Drug's FAERS reports marked serious
- 29.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, psychiatry, dermatology
- Drugs matched to FDA substances
- nicotine
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
- Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction NCT01466270 · started 2012 · scored riskier than 90% of active trials completed
- Effect of Methylphenidate on Cancer-related Cognitive Impairment NCT02970500 · started 2017 · scored riskier than 85% of active trials terminated
- Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer NCT04033419 · started 2019 · scored riskier than 90% of active trials completed
- Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy NCT04468230 · started 2020 · scored riskier than 84% of active trials terminated
- Memory Improvement Through Nicotine Dosing (MIND) Study NCT02720445 · started 2017 · scored riskier than 55% 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.