Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation
Model scores of the 29,894 trials active now.
Model score 5% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (734 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
Terminated on 2009-02-28, after 2008-11-30 start.
Reason given by the sponsor: “business”
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 2009-02-28. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: advancedconcurrentthe subjectpatientbreast
Phrases that lowered it: drugeffect ofthe effectphysicalevaluate the -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports with a death: 12.5% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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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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Sponsor's past trials: 6 (lowers risk) · Sponsor's track record
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Primary purpose: supportive care (raises risk) · Design
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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
- supportive care (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 6 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 8 (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
- 5423 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1383 (typical: 412.5)
- Drug's FAERS reports marked serious
- 83.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- bupivacaine, epinephrine
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
- Evaluation of the Safety and Efficacy of a Single Dose of SKY0402 in Subjects Undergoing Augmentation Mammoplasty NCT01206608 · started 2008 · scored riskier than 8% of active trials completed
- Phase 2B Upper Extremity Nerve Block Study NCT03011333 · started 2017 · scored riskier than 13% of active trials completed
- Study to Evaluate EB-001 in Reducing Musculoskeletal Pain NCT03193593 · started 2017 · scored riskier than 9% of active trials completed
- A Phase 3 Study to Evaluate the Safety and Efficacy of SKY0402 in Subjects Undergoing Total Knee Arthroplasty NCT00745290 · started 2008 · scored riskier than 10% of active trials completed
- Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block With EXPAREL in Shoulder Surgery NCT02713230 · started 2016 · scored riskier than 29% 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.