Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2019-12-20, after 2018-11-16 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 2019-12-20. 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) (raises risk) · Wording
Phrases that raised it: priorcnsthe trialcancersitu
Phrases that lowered it: and safetyefficacy andhypertensiondiseasedose -
Sponsor's past termination rate: 29.4% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Minimum age: 21 (lowers risk) · Who can join
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Disease area, cancer: Yes (raises risk) · Disease area
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 23.9% (raises risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, respiratory: Yes (raises risk) · Disease area
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Drug's FAERS reports before start: 3882 (raises risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 17 (typical: 32)
- Sponsor's past termination rate
- 29.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 11 (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
- 3882 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 979 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, neurology, respiratory
- Drugs matched to FDA substances
- afatinib
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
- Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation NCT01953913 · started 2013 · scored riskier than 22% of active trials completed
- A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations NCT01647711 · started 2012 · scored riskier than 37% of active trials completed
- Maintaining ERBB Blockade in EGFR-mutated Lung Cancer NCT02488694 · started 2015 · scored riskier than 94% of active trials terminated
- Trial of Afatinib (BIBW 2992) + Cetuximab in Advanced Solid Tumours NCT02020577 · started 2013 · scored riskier than 16% of active trials completed
- Safety Study of Afatinib for Brain Cancer NCT02423525 · started 2016 · scored riskier than 92% 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.