Safety Study to Evaluate BMS-830216 in Healthy Subjects
Model scores of the 29,894 trials active now.
Model score 14% 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 6% of the time (816 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 2009-09-30, after 2009-05-31 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 2009-09-30. 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: bmstolerabilityascendingand pharmacokineticsthe safety
Phrases that lowered it: healthyevaluate theto evaluatesingle dosemg -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: parallel (raises risk) · Design
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Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: 8.3% (raises risk) · Sponsor's track record
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Blinding: double (raises risk) · Design
-
Number of arms: 6 (lowers risk) · Design
-
Responsible party: not given (raises risk) · Design
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past trials: 181 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 111 (lowers 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
- 1 (typical: 2)
- Number of arms
- 6 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (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
- 181 (typical: 32)
- Sponsor's past termination rate
- 8.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 111 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic
- Drugs matched to FDA substances
- none matched
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
- Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects NCT02341638 · started 2014 · scored riskier than 10% of active trials completed
- Study to Evaluate the Safety, Tolerability, PK, and PD of BMS-986090 in Healthy Subjects NCT02079480 · started 2014 · scored riskier than 7% of active trials terminated
- Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy Subjects NCT02257151 · started 2014 · scored riskier than 6% of active trials completed
- Single Ascending Dose (BMS-813160) Study NCT01049165 · started 2010 · scored riskier than 16% of active trials completed
- Safety and Tolerability Study of BMS-986177 in Healthy Subjects NCT02608970 · started 2015 · scored riskier than 11% 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.