A Study to Evaluate the Effect of Hepatic Impairment on Lazertinib (JNJ-73841937)
Model scores of the 29,894 trials active now.
Model score 3% for any early termination, 1% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-07-11, after 2021-11-30 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 2022-07-11. 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: heartdiseasecardiacacutefunction
Phrases that lowered it: healthyparticipantsparticipantthe pharmacokineticssingle -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: 10% (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 7.7% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 122 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 4 (lowers risk) · Design
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Maximum age: 80 (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
- 4 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- basic science (typical: 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
- 18
- Maximum age
- 80 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 490 (typical: 32)
- Sponsor's past termination rate
- 10% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 122 (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
- 13 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 13 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- lazertinib
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
- Safety and Pharmacokinetics Study of Linzagolix in Female Subjects With Normal and Impaired Hepatic Function NCT03962049 · started 2019 · scored riskier than 4% of active trials completed
- Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Hepatic Function NCT02412098 · started 2015 · scored riskier than 5% of active trials completed
- Study on the Safety of BAY1817080, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug in Participants With Impaired Liver Function or Normal Liver Function NCT04454424 · started 2020 · scored riskier than 11% of active trials completed
- Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function NCT01923870 · started 2013 · scored riskier than 7% of active trials completed
- Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic Function NCT05283915 · started 2022 · scored riskier than 8% 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.