Effect of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects
Model scores of the 29,894 trials active now.
Model score 3% 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: longmsintervalof bi100
Phrases that lowered it: healthymmhgblood pressurecrossoverdrug -
Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 2.8% (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 159 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Minimum age: 21 (lowers risk) · Who can join
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Drug's FAERS reports with a death: 12.9% (lowers risk) · Drug's FDA history
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Blinding: double (raises risk) · Design
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Number of arms: 4 (lowers risk) · Design
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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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Maximum age: 50 (lowers risk) · Who can join
-
Sponsor's past trials: 72 (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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: 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
- 21 (typical: 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
- 72 (typical: 32)
- Sponsor's past termination rate
- 2.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 159 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 680 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 201 (typical: 412.5)
- Drug's FAERS reports marked serious
- 83.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- linagliptin, moxifloxacin
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
- This Study in Healthy Men and Women Tests Whether BI 409306 Has an Effect on the ECG (Thorough QT Study) NCT03934203 · started 2019 · scored riskier than 4% of active trials completed
- Assessment of the Effect of BI 201335 on the QT Interval in Healthy Female and Male Subjects NCT02182310 · started 2008 · scored riskier than 2% of active trials completed
- Relative Bioavailability of BI 10773 Administered Twice Daily Compared BI 10773 Given Once Daily After Multiple Oral Doses in Healthy Male and Female Volunteers NCT02782624 · started 2009 · scored riskier than 1% of active trials completed
- Pharmacokinetics and Pharmacodynamics of Multiple 5 mg Doses of BI 1356 p.o. Given Once Daily Compared to Multiple 2.5 mg Doses Given Twice Daily in Healthy Male and Female Volunteers NCT02173652 · started 2008 · scored riskier than 3% of active trials completed
- Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 44370 TA Tablets in Healthy Male and Female Volunteers NCT02215759 · started 2009 · 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.