Efficacy and Safety of A Collagen Bupivacaine Implant in Patients After Gastrointestinal Surgery
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
Terminated on 2009-02-10, after 2008-07-24 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 2009-02-10. 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: surgerycancerthe patientpatient hasgi
Phrases that lowered it: screeningphysicalkgmass indexbody mass -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Drug's FAERS reports with a death: 10.3% (lowers risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Blinding: triple (raises risk) · Design
-
Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports marked serious: 79.5% (lowers 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
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 2 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (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
- 1248 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 291 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- bupivacaine, collagen
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 the CollaRx Bupivacaine Implant Compared to the ON-Q Painbuster Following Abdominal Hysterectomy NCT00749749 · started 2008 · scored riskier than 17% of active trials completed
- Efficacy, Safety and Pharmacokinetic Profile of a Collagen Bupivacaine Implant in Men After Open Mesh Herniorrhaphy NCT00626886 · started 2008 · scored riskier than 16% of active trials completed
- Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Laparoscopic Colorectomy NCT02992041 · started 2016 · scored riskier than 22% of active trials completed
- Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Colorectal Surgery NCT02489526 · started 2015 · scored riskier than 19% of active trials completed
- Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy NCT01220024 · started 2010 · 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.