A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.
Model scores of the 29,894 trials active now.
Model score 12% 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 9% of the time (181 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 2013-04-24, after 2012-06-12 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 2013-04-24. 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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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subject hasseverediseaseuncontrolledsubject is
Phrases that lowered it: efficacyand safetysafety ofpregnantto evaluate -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers 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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Blinding: double (raises risk) · Design
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Drug's FAERS reports with a death: 14.0% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 2 (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 5 (raises risk) · Sponsor's track record
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Number of arms: 2 (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 11 (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
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 5 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 336 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 120 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- mirabegron, solifenacin
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
- Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder NCT00689104 · started 2008 · scored riskier than 15% of active trials completed
- A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin) NCT01908829 · started 2013 · scored riskier than 30% of active trials completed
- A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder NCT00662909 · started 2008 · scored riskier than 33% of active trials completed
- A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder NCT00912964 · started 2009 · scored riskier than 22% of active trials completed
- This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder NCT01972841 · started 2013 · scored riskier than 10% 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.