A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT)
Model scores of the 29,894 trials active now.
Model score 21% for any early termination, 3% 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
Terminated on 2023-03-31, after 2022-09-20 start.
Reason given by the sponsor: “safety”
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 2023-03-31. 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: placeboheartcoronarychroniccardiac
Phrases that lowered it: participantsparticipantvisitaccording28 days -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past trials: 977 (raises risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 57 (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Blinding: quadruple (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises 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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Sponsor's past termination rate: 7.9% (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Number of arms: 3 (lowers risk) · Design
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Collaborators: 0 (raises 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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 79 (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
- 977 (typical: 32)
- Sponsor's past termination rate
- 7.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 57 (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
- Pharmacodynamic and Pharmacokinetic Study of BiDil Extended-release Capsules and Commercial BiDil Tablets NCT02522208 · started 2015 · scored riskier than 29% of active trials completed
- Study to Assess the Safety, Tolerability and PK/PD After 4 Weekly SC Injections of PB1046 in Subjects With Stable HFrEF NCT02808585 · started 2016 · scored riskier than 30% of active trials completed
- Phase Ib/IIa Trial With AC01 in Patients With HFrEF NCT05642507 · started 2023 · scored riskier than 35% of active trials completed
- A Study to Learn How Safe Starting Vericiguat at a Dose of 5 Milligrams is in Participants With Chronic Heart Failure With Reduced Ejection Fraction NCT06195930 · started 2024 · scored riskier than 71% of active trials completed
- A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation NCT05636176 · started 2023 · scored riskier than 76% of active trials terminated
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.