A Pilot Study Comparing the Safety and Efficacy of Everolimus With Other Medicines in Recipients of ECD/DCD Kidneys
Model scores of the 29,894 trials active now.
Model score 26% for any early termination, 11% 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 (60 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
Terminated on 2017-12-31, after 2013-06-30 start.
Reason given by the sponsor: “safety”
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 2017-12-31. 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: cellpatientscountdlheart
Phrases that lowered it: controlledto evaluateinvestigatorsafetyefficacy -
Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports with a death: 27.3% (raises risk) · Drug's FDA history
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Responsible party: sponsor investigator (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Number of arms: 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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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Maximum age: 65 (lowers risk) · Who can join
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Drug's FAERS reports marked serious: 95.6% (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 0 (raises risk) · Sponsor's track record
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Blinding: none (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 9905 (lowers risk) · Drug's FDA history
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Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
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
- 2/3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 65 (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
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 44609 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 9905 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- everolimus, mycophenolate mofetil, mycophenolic acid, tacrolimus
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
- Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids NCT00658320 · started 2008 · scored riskier than 25% of active trials completed
- Once-a-day Regimen With Everolimus, Low Dose Cyclosporine and Steroids in Comparison With Steroid Withdrawal or Twice a Day Regimen With Everolimus, Low Dose Cyclosporine and Steroids. NCT01023815 · started 2009 · scored riskier than 44% of active trials completed
- Envarsus® Once Daily With Everolimus in Elderly Kidney Transplant Recipients: Pharmacokinetic and Clinical Study NCT02970630 · started 2017 · scored riskier than 64% of active trials completed
- Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx NCT01187953 · started 2010 · scored riskier than 17% of active trials completed
- Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI)Versus a CNI-free Treatment in Renal Transplantation (CIME) NCT01595984 · started 2012 · scored riskier than 35% 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.