Efficacy and Safety Evaluating Study to Compare Uritos® (Imidafenacin) and Urotol® (Tolterodine) for Treatment of Overactive Bladder.
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 4% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-09-01, after 2016-07-18 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 2017-09-01. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: heartdementiaacutechronicms
Phrases that lowered it: diseasesand safetysafety ofmaleintake -
Sponsor's past termination rate: 12.9% (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 7.4% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Drug's FAERS reports marked serious: 67.5% (lowers risk) · Drug's FDA history
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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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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Collaborators: 1 (raises risk) · Design
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Keywords listed: 5 (lowers 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
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (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
- 31 (typical: 32)
- Sponsor's past termination rate
- 12.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- 7657 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1229 (typical: 412.5)
- Drug's FAERS reports marked serious
- 67.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- imidafenacin, tolterodine
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
- Efficacy and Safety of GSK1358820 in Subjects With Overactive Bladder NCT02820844 · started 2016 · scored riskier than 30% of active trials completed
- Efficacy and Safety Study of GSK1358820 in Japanese Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity NCT02849418 · started 2016 · scored riskier than 34% of active trials completed
- Clinical Study to Evaluate the Treatment Effect and Safety of BAY1817080 in Patients With Overactive Bladder (OAB) NCT04545580 · started 2020 · scored riskier than 25% 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
- A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder NCT01340027 · started 2011 · scored riskier than 16% 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.