Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011
Model scores of the 29,894 trials active now.
Model score 3% for any early termination, 0% 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 2017-01-09, after 2015-03-25 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 2017-01-09. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjects withtransplantsubject hasin subjectstherapy
Phrases that lowered it: healthythe pharmacokineticskgsinglebetween 18 -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 13.4% (raises risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Drug's FAERS reports with a death: 23.1% (raises risk) · Drug's FDA history
-
Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 4 (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Blinding: none (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor's past trials: 751 (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 246 (raises risk) · Sponsor's track record
-
Maximum age: 75 (raises risk) · Who can join
-
Responsible party: sponsor (lowers 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
- 4 (typical: 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
- 18
- Maximum age
- 75 (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
- 751 (typical: 32)
- Sponsor's past termination rate
- 13.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 246 (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
- 11 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ribociclib
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
- Effect of Hepatic Impairment on LDE225.. NCT01764776 · started 2013 · scored riskier than 4% of active trials completed
- An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage NCT06952634 · started 2025 · scored riskier than 4% of active trials completed
- Study of Nalbuphine ER in Participants With Hepatic Impairment NCT04020016 · started 2019 · scored riskier than 4% of active trials completed
- 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
- Effect of Hepatic Impairment on LDK378 Pharmacokinetics NCT01950481 · started 2014 · scored riskier than 4% 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.