CNI-free de Novo Protocol in Patients Undergoing Liver Transplantation With Renal Impairment
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 10% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 19% of the time (90 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2012-08-31, after 2008-12-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2012-08-31. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: transplantationlivertransplantfunctiontherapy
Phrases that lowered it: safetyefficacybodystudysigns -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 98.8% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Responsible party: principal investigator (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: not given (raises risk) · Who can join
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Has a data monitoring committee: No (lowers risk) · Design
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Number of arms: 1 (raises risk) · Design
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Sponsor's past trials: 0 (raises risk) · Sponsor's track record
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
- 3 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 1200 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 432 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive, urogenital
- Drugs matched to FDA substances
- basiliximab, mycophenolic acid, sirolimus
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
- Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients NCT01114529 · started 2010 · scored riskier than 64% of active trials completed
- REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy NCT02115113 · started 2014 · scored riskier than 64% of active trials completed
- Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients NCT00622869 · started 2008 · scored riskier than 55% of active trials completed
- Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function NCT04258423 · started 2019 · scored riskier than 82% of active trials terminated
- Everolimus Monotherapy as Immunosuppression After Liver Transplant NCT04063865 · started 2019 · scored riskier than 52% of active trials terminated
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.