A Study to Evaluate the Safety, Tolerability and Efficacy of LB1148 for Subjects Undergoing Elective Bowel Resection
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 13% 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 (81 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-12-01, after 2018-11-05 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 2020-12-01. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjectboweldiseasesubjects withchronic
Phrases that lowered it: efficacyevaluate theto evaluatesmallsafety -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Primary purpose: prevention (lowers risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Responsible party: sponsor investigator (raises risk) · Design
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Design: single group (raises risk) · Design
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Drug's FAERS reports marked serious: 95.5% (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports before start: 3583 (raises risk) · Drug's FDA history
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Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
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
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- prevention (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 85 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- 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
- 0 (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
- 3583 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 714 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- tranexamic acid
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
- Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative Ileus NCT05056935 · started 2019 · scored riskier than 58% of active trials completed
- A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection NCT02836470 · started 2019 · scored riskier than 57% of active trials completed
- A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection NCT05470387 · started 2022 · scored riskier than 52% of active trials terminated
- Study to Evaluate the Safety of Post-Operative TZP-101 (IV Ulimorelin) After Partial Bowel Resection NCT01710982 · started 2012 · scored riskier than 12% of active trials completed
- Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery in Subjects Undergoing Bowel Resection NCT04742907 · started 2021 · scored riskier than 87% 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.