Safety, Tolerability, and Pharmacokinetics of BI 201335 NA in Healthy Male Subjects
Model scores of the 29,894 trials active now.
Model score 9% 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 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.
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. 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 tolerabilityof bithe trialtolerability anddoses
Phrases that lowered it: blood pressuregastrointestinalkgdrugsdrug -
Sponsor's past termination rate: 2.7% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 172 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Minimum age: 20 (lowers risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Blinding: double (raises risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Sponsor's past trials: 73 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Sponsor type: industry (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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 35 (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
- 73 (typical: 32)
- Sponsor's past termination rate
- 2.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 172 (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
- none of the 14 tracked areas
- 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
- A Study to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body of Healthy Japanese Men NCT06494774 · started 2024 · scored riskier than 19% of active trials completed
- A Study in Healthy Men to Test How Well Different Doses of BI 1839100 Are Tolerated (1490-0003) NCT05934955 · started 2023 · scored riskier than 16% of active trials completed
- A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated NCT04958252 · started 2021 · scored riskier than 8% of active trials completed
- A Study in Healthy Japanese Men to Test How Well Different Doses of BI 1291583 Are Tolerated NCT05183347 · started 2022 · scored riskier than 22% of active trials completed
- A Study in Healthy Japanese Men to Test How Well Different Doses of BI 764198 Are Tolerated NCT04665700 · started 2021 · scored riskier than 14% 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.