BAY1238097, First in Man
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,938 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2016-01-31, after 2015-03-31 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 2016-01-31. 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) (raises risk) · Wording
Phrases that raised it: leukemiaulnmsectumorsubject
Phrases that lowered it: myelomadays beforefirst dosepharmacokineticstablets -
Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 6.0% (lowers risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 117 (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
-
Design: single group (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Disease area, dermatology: Yes (raises risk) · Disease area
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Number of arms: 1 (raises risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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
- 9 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 548 (typical: 32)
- Sponsor's past termination rate
- 6.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 117 (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
- cancer, immunology, dermatology, hematology
- 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
- Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors NCT06714617 · started 2025 · scored riskier than 44% of active trials terminated
- A Study to Evaluate TAK-931 in Participants With Advanced Nonhematologic Tumors NCT02699749 · started 2016 · scored riskier than 15% of active trials completed
- Study of DS-8201a, an Antibody Drug Conjugate for Advanced Breast Cancer Patients, With Biomarkers Analysis NCT04132960 · started 2019 · scored riskier than 98% of active trials completed
- Monotherapy Dose Finding With BI 847325 in Solid Tumours NCT01324830 · started 2011 · scored riskier than 14% of active trials completed
- A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer NCT04137289 · started 2020 · scored riskier than 29% 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.