Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy
Model scores of the 29,894 trials active now.
Model score 5% for any early termination, 2% 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 (273 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 2015-11-30, after 2014-09-30 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 2015-11-30. 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) (lowers risk) · Wording
Phrases that raised it: patientuncontrolledpatients withhypertensioncontrolled
Phrases that lowered it: and safetyefficacy andkgsafety ofmass index -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Blinding: triple (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 26 (lowers risk) · Sponsor's track record
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Maximum age: 60 (lowers risk) · Who can join
-
Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 4 (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
-
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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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports with a death: no FAERS history (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
- 2/3 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 60 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- 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
- 26 (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
- Gabapentin in Reducing the Need for Pain Medication in Patients With Bladder Cancer Undergoing Radical Cystectomy NCT02355886 · started 2015 · scored riskier than 73% of active trials completed
- Perioperative Pregabalin for Reducing Opioid Consumption After Cardiac Surgery NCT04517110 · started 2021 · scored riskier than 27% of active trials terminated
- Analgetic Effect of Preoperative Pregabalin in Patients Undergoing Nephrectomy NCT00957177 · started 2009 · scored riskier than 9% of active trials completed
- Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy NCT04300231 · started 2019 · scored riskier than 64% of active trials completed
- Pregabalin in the Prevention of Postoperative Delirium and Pain NCT00819988 · started 2009 · scored riskier than 15% 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.