A Study to Learn About Whether BAYH006689 Causes Skin Irritation When Applied as a Topical Gel in Healthy Participants
Model scores of the 29,894 trials active now.
Model score 5% 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 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 2024-08-20, after 2024-07-23 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 2024-08-20. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: painpurpose ofcalledcausecare
Phrases that lowered it: participantsparticipanthealthyjointvisit -
Primary purpose: other (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
-
Drug's FAERS reports marked serious: 58.0% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 6.1% (lowers risk) · Drug's FDA history
-
Sponsor's past termination rate: 8.5% (raises risk) · Sponsor's track record
-
Sponsor's past trials: 1038 (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 50 (lowers risk) · Sponsor's track record
-
Blinding: triple (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
-
Number of arms: 4 (lowers risk) · Design
-
Drug's FAERS reports in the prior 12 months: 9126 (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
- other (typical: treatment)
- Blinding
- triple (typical: 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
- not given (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
- 1038 (typical: 32)
- Sponsor's past termination rate
- 8.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 50 (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
- 158116 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 9126 (typical: 412.5)
- Drug's FAERS reports marked serious
- 58.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- naproxen
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 to Learn About Whether BAY H006689 Causes an Allergic Reaction When Applied as a Topical Gel in Healthy Participants NCT06415019 · started 2024 · scored riskier than 4% of active trials completed
- A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants NCT04882631 · started 2021 · scored riskier than 3% of active trials completed
- Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design NCT06369675 · started 2017 · scored riskier than 2% of active trials completed
- Dermal Irritation, Sensitization and Cumulative Irritation Potential of 6% Bemotrizinol NCT05260359 · started 2022 · scored riskier than 3% of active trials completed
- Cumulative Irritation Test NCT00781664 · started 2008 · scored riskier than 5% 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.