A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
Model scores of the 29,894 trials active now.
Model score 6% 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 2017-11-29, after 2017-05-11 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 2017-11-29. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: bmsof studyrecurrenttolerability pharmacokineticssafety tolerability
Phrases that lowered it: healthyvolunteersparticipants90kg -
Sponsor's past termination rate: 10.8% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Primary purpose: screening (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 106 (lowers 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: 18.0% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor's past trials: 564 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 24845 (raises risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 74.1% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: quadruple (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports before start: 165880 (lowers risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- screening (typical: treatment)
- Blinding
- quadruple (typical: 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
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 564 (typical: 32)
- Sponsor's past termination rate
- 10.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 106 (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
- 165880 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 24845 (typical: 412.5)
- Drug's FAERS reports marked serious
- 74.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- diphenhydramine, famotidine
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
- A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects NCT02790125 · started 2016 · scored riskier than 42% of active trials completed
- A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers NCT03038711 · started 2017 · scored riskier than 6% of active trials completed
- Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects NCT02739373 · started 2016 · scored riskier than 11% of active trials completed
- Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects NCT02705989 · started 2016 · scored riskier than 8% of active trials completed
- A Study of BMS-986195 in Healthy Male Subjects NCT03245515 · started 2017 · 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.