Investigation of the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Patients With Non-small Cell Lung Cancer
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 2% 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 (1,938 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2017-11-28, after 2016-05-20 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 2017-11-28. 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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Phase: 1 (lowers risk) · Design
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Primary purpose: other (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cancercellpatienttherapysmall
Phrases that lowered it: effect ofthe effectthe pharmacokineticsinvestigate therelevant -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 5.7% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 11.0% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 110 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Drug's FAERS reports marked serious: 62.5% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Sponsor's past trials: 383 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Disease area, respiratory: Yes (raises risk) · Disease area
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Responsible party: sponsor (lowers risk) · Design
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Number of arms: 1 (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
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 383 (typical: 32)
- Sponsor's past termination rate
- 5.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 110 (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
- 3287 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2197 (typical: 412.5)
- Drug's FAERS reports marked serious
- 62.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, respiratory
- Drugs matched to FDA substances
- ethinyl estradiol levonorgestrel, nintedanib
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
- Nintedanib in Patients With Advanced Esophagogastric Cancer NCT02234596 · started 2014 · scored riskier than 75% of active trials completed
- Nintedanib Plus Docetaxel in Japanese Patients With Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy NCT02300298 · started 2014 · scored riskier than 14% of active trials completed
- Cisplatin, Docetaxel, and Nintedanib Before Surgery in Treating Patients With Previously Untreated Stage IB-IIIA Non-small Cell Lung Cancer NCT02225405 · started 2015 · scored riskier than 84% of active trials completed
- Nintedanib Compared With Placebo in Treating Against Radiation-Induced Pneumonitis in Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery and Are Undergoing Chemoradiation Therapy NCT02452463 · started 2015 · scored riskier than 93% of active trials terminated
- Phase II Study of Docetaxel +/- Nintedanib in Breast Cancer NCT01658462 · started 2013 · scored riskier than 87% 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.