A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood
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 2023-10-04, after 2022-11-24 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 2023-10-04. 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) (lowers risk) · Wording
Phrases that raised it: subjectsprmultiplethe followingstroke
Phrases that lowered it: healthypharmacokineticstrialbloodrelevant -
Phase: 1 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Sponsor's past termination rate: 8.7% (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 2.1% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 96 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 64.8% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor's past trials: 716 (raises risk) · Sponsor's track record
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Blinding: none (lowers risk) · Design
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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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (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
- 35 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 716 (typical: 32)
- Sponsor's past termination rate
- 8.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 96 (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
- 7630 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 723 (typical: 412.5)
- Drug's FAERS reports marked serious
- 64.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ethinyl estradiol levonorgestrel
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
- Effect of Multiple BI 1356 Doses of on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Female Premenopausal Subjects NCT02175394 · started 2008 · scored riskier than 3% of active trials completed
- Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel NCT01941615 · started 2013 · scored riskier than 2% of active trials terminated
- This Study Tests in Healthy Korean Women Which Effects BI 409306 and a Birth-control Pill Have on Each Other NCT03193307 · started 2017 · scored riskier than 7% of active trials completed
- A Study to Test How Healthy Women Tolerate Different Doses of BI 1819479 NCT05440799 · started 2022 · scored riskier than 14% 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
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.