A Study of Vestipitant (GW597599) in the Treatment of Breakthrough Postoperative Nausea and Vomiting (PONV)
Model scores of the 29,894 trials active now.
Model score 9% 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 13% of the time (1,304 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 2012-08-31, after 2012-02-29 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 2012-08-31. 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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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: ivsubject hasthe subjectsubject isintravenous
Phrases that lowered it: tubeevaluateanesthesiahas historymoderate -
Blinding: single (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Design: parallel (raises risk) · Design
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Number of arms: 6 (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Maximum age: 75 (lowers risk) · Who can join
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Drug's FAERS reports with a death: 20.2% (lowers risk) · Drug's FDA history
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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
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
- 6 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (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
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (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
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 6905 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1918 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ondansetron
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
- Pilot Study to Assess Palonosetron Versus Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU) NCT00967499 · started 2009 · scored riskier than 24% of active trials completed
- Dose-ranging Study of APD405 in Post-operative Nausea and Vomiting (PONV) NCT00895830 · started 2009 · scored riskier than 28% of active trials completed
- Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients NCT01395901 · started 2011 · scored riskier than 30% of active trials completed
- A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219) NCT01732458 · started 2013 · scored riskier than 63% of active trials completed
- Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting NCT01568268 · started 2012 · scored riskier than 8% 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.