This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Taken up in the Body and How Well They Are Tolerated
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 2018-05-26, after 2017-09-04 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 2018-05-26. 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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Minimum age: 20 (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: and pharmacodynamicssafety tolerabilityrisingtolerability pharmacokineticssafe
Phrases that lowered it: trialrelevantvaccinationhealthydays -
Phase: 1 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 111 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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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
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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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Sponsor's past termination rate: 6.6% (lowers risk) · Sponsor's track record
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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
- treatment
- Blinding
- single (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
- 45 (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
- 457 (typical: 32)
- Sponsor's past termination rate
- 6.6% (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
- 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
- Safety, Tolerability and Pharmacokinetics of BI 1026706 in Healthy Chinese and Japanese Male Volunteers NCT02652416 · started 2016 · scored riskier than 7% of active trials completed
- This Study Tests BI 1467335 in Healthy Japanese and Caucasian Men. The Study Tests How Different Doses of BI 1467335 Are Taken up in the Body and How Well They Are Tolerated NCT03159455 · started 2017 · scored riskier than 10% of active trials completed
- A Study in Healthy Men and Women to Find Out How Well Different Doses of BI 1291583 Are Tolerated NCT03868540 · started 2019 · scored riskier than 10% of active trials terminated
- A Study in Healthy Japanese Men to Test How Different Doses of BI 690517 Are Taken Up in the Body and How Well They Are Tolerated NCT03608072 · started 2018 · scored riskier than 9% of active trials completed
- Safety, Tolerability and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Healthy Asian and Caucasian Male Volunteers NCT02596217 · started 2015 · scored riskier than 6% 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.