A Study in Healthy People to Test How Well Different Doses of BI 3000202 Are Tolerated and How They Affect the Way the Body Handles Midazolam
Model scores of the 29,894 trials active now.
Model score 10% 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 2024-09-27, after 2024-04-09 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 2024-09-27. 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) (raises risk) · Wording
Phrases that raised it: safety tolerabilitysubjectsmultipletolerability pharmacokineticsrising
Phrases that lowered it: healthytrialthe pharmacokineticsthe effecteffect of -
Sponsor's past termination rate: 8.3% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Blinding: triple (raises risk) · Design
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Sponsor's past trials: 787 (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 103 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports before start: 29306 (lowers risk) · Drug's FDA history
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Number of arms: 4 (lowers risk) · Design
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Drug's FAERS reports with a death: 20.2% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises 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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- triple (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
- 787 (typical: 32)
- Sponsor's past termination rate
- 8.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 103 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 29306 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2705 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- midazolam
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 Study to Test How Well Different Doses of BI 1584862 Are Tolerated by Healthy Men NCT06006598 · started 2023 · scored riskier than 15% of active trials completed
- A Study in Healthy Men to Test Whether BI 425809 Influences the Amount of Midazolam in the Blood NCT05258110 · started 2022 · scored riskier than 6% of active trials completed
- A Study to Test How Healthy Men Tolerate Different Doses of BI 1595043 NCT04789304 · started 2021 · scored riskier than 13% of active trials completed
- A Study to Test How Well Different Doses of BI 1815368 Are Tolerated by Healthy Men NCT05857878 · started 2023 · scored riskier than 21% of active trials completed
- A Study in Healthy Men to Test How Different Doses of BI 1595043 Are Tolerated NCT04439838 · started 2020 · scored riskier than 18% 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.