Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A
Model scores of the 29,894 trials active now.
Model score 13% 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 10% of the time (139 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 on 2020-02-19, after 2013-05-29 start.
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; it actually ended on 2020-02-19. 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: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
-
Sponsor's past trials: 471 (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjectslongsubjectsafety andand efficacy
Phrases that lowered it: trialpatientsefficacyphase iiiopen label -
Design: single group (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 79 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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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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Number of arms: 3 (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Maximum age: 12 (raises risk) · Who can join
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Sex: male (lowers risk) · Who can join
-
Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 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
- 3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 12 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 471 (typical: 32)
- Sponsor's past termination rate
- 6.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 79 (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
- 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
- A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A NCT01580293 · started 2012 · scored riskier than 32% of active trials completed
- BAY81-8973 Pediatric Safety and Efficacy Trial NCT01311648 · started 2011 · scored riskier than 13% of active trials completed
- Trial to Evaluate the Pharmacokinetics and Safety Profile of BAY94-9027 Following Single and Multiple Dose Administration NCT01184820 · started 2010 · scored riskier than 22% of active trials completed
- BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A NCT00623727 · started 2008 · scored riskier than 13% of active trials terminated
- A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150 NCT01625390 · started 2012 · scored riskier than 11% 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.