Effects of BMS-986256 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil
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 2019-10-16, after 2019-07-22 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 2019-10-16. 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: bmscellcarcinomasquamoussurgery
Phrases that lowered it: healthyparticipantsto investigatescreeningeffect -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: 10.5% (raises risk) · Sponsor's track record
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Primary purpose: prevention (lowers risk) · Design
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 102 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports with a death: 18.4% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 667 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Blinding: none (lowers risk) · Design
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Maximum age: 55 (lowers 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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- prevention (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
- 55 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 667 (typical: 32)
- Sponsor's past termination rate
- 10.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 102 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 63761 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 13612 (typical: 412.5)
- Drug's FAERS reports marked serious
- 88.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- mycophenolate mofetil, mycophenolic acid
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
- An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants NCT03660436 · started 2018 · scored riskier than 2% of active trials completed
- Study to Investigate the Effect of BMS-986142 on the Pharmacokinetics (PK) of Methotrexate and Probe Substrate Cocktail in Healthy Patients NCT02456844 · started 2015 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fasting Conditions NCT01513044 · started 2009 · scored riskier than 0% of active trials completed
- A Study to Assess the Absorption of a Single Dose of BMS-986205 in Healthy Volunteers When Administered as a Crushed Tablet Orally or Crushed Tablet Suspension Via Nasogastric Tube, as Compared to a Tablet NCT03362411 · started 2017 · scored riskier than 0% of active trials completed
- An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants NCT03419910 · started 2018 · scored riskier than 2% 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.