A Study in Healthy Men to Test How Different Doses of BI 1584862 Are Tolerated and How BI 1584862 is Taken up in the Body With or Without Food
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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-03-06, after 2022-09-29 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 2023-03-06. 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
-
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: safety tolerabilitysubjectsbitolerability andsingle rising
Phrases that lowered it: tabletblood pressuremmhgfood90 -
Design: parallel (raises risk) · Design
-
Sponsor's past termination rate: 8.8% (raises risk) · Sponsor's track record
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 101 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Sponsor's past trials: 707 (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Number of arms: 4 (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
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
- 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
- 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
- 707 (typical: 32)
- Sponsor's past termination rate
- 8.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 101 (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 in Healthy Men to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body With or Without Food NCT05337592 · started 2022 · scored riskier than 8% of active trials completed
- A Study to Test How Well Different Doses of BI 1584862 Are Tolerated by Healthy Men NCT06006598 · started 2023 · scored riskier than 15% of active trials completed
- A Study in Healthy Men to Test How Different Doses of BI 3031185 Are Tolerated and How Food Influences the Amount of BI 3031185 in the Blood NCT06255340 · started 2024 · scored riskier than 6% of active trials completed
- A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated and Taken up by the Body With or Without Food NCT04801693 · started 2021 · scored riskier than 21% of active trials completed
- A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood NCT05945888 · started 2023 · 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.