A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder
Model scores of the 29,894 trials active now.
Model score 10% 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 17% of the time (192 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 2012-06-28, after 2011-03-29 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 2012-06-28. 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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Design: factorial (lowers risk) · Design
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subject hasulndefinedfailureuncontrolled
Phrases that lowered it: malekgbodydrugperiod -
Phase: 2 (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Number of arms: 12 (lowers risk) · Design
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Disease area, urogenital: Yes (raises risk) · Disease area
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 15.5% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: triple (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (lowers risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
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Keywords listed: 7 (lowers risk) · Design
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Sponsor's past trials: 16 (lowers risk) · Sponsor's track record
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
- 2
- Number of arms
- 12 (typical: 2)
- Allocation
- randomized
- Design
- factorial (typical: parallel)
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 7 (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
- 16 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 12 (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
- 187 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 51 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.6%
- Drug's FAERS reports with a death
- 15.5% (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
- A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin) NCT01908829 · started 2013 · scored riskier than 30% of active trials completed
- Urodynamic and Clinical Efficacy of Mirabegron for Neurogenic Bladder Patients NCT02044510 · started 2014 · scored riskier than 68% of active trials terminated
- 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
- A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder NCT02045862 · started 2014 · scored riskier than 9% of active trials completed
- A Study of ASP8302 in Participants With Underactive Bladder NCT03702777 · started 2018 · scored riskier than 47% 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.