A Study in Healthy People to Test Whether Erythromycin Influences the Amount of BI 1291583 in the Blood
Model scores of the 29,894 trials active now.
Model score 4% 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 2025-09-09, after 2025-04-29 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 2025-09-09. 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) (lowers risk) · Wording
Phrases that raised it: including butlimited tonot limitedhormonepr
Phrases that lowered it: healthymalethe investigatorinclusiverelevant -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: 8.7% (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 8.6% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 115 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 855 (raises 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
-
Drug's FAERS reports marked serious: 61.4% (lowers risk) · Drug's FDA history
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Blinding: none (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports before start: 18110 (lowers risk) · Drug's FDA history
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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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- 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
- 50 (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
- 855 (typical: 32)
- Sponsor's past termination rate
- 8.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 115 (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
- 18110 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1359 (typical: 412.5)
- Drug's FAERS reports marked serious
- 61.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- erythromycin
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 in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood NCT06367153 · started 2024 · scored riskier than 3% of active trials completed
- Interaction of BI 425809 With Midazolam, Warfarin, Omeprazole and Digoxin NCT02783040 · started 2015 · scored riskier than 3% of active trials completed
- A Study to Test How Food Influences the Amount of BI 1291583 in the Blood of Healthy Men NCT03837964 · started 2019 · scored riskier than 4% of active trials completed
- This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 1358894 Affects the Way the Body Breaks Down Midazolam NCT03754959 · started 2018 · scored riskier than 9% of active trials completed
- A Study in Healthy Men Tests How Different Doses of BI 764198 Are Taken up in the Body and How Well They Are Tolerated. NCT03854552 · started 2019 · 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.