Efficacy, Safety and Tolerability of a New Bowel Cleansing Preparation (BLI800) in Adult Subjects Undergoing Colonoscopy
Model scores of the 29,894 trials active now.
Model score 8% 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 10% of the time (1,463 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2019-04-28, after 2018-07-01 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 2019-04-28. 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
-
Sponsor's past termination rate: 21.5% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: boweladvancedbleedingcancerknown
Phrases that lowered it: subjectsscreeningsubjectmaleor disorder -
Phase: 3 (lowers risk) · Design
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Primary purpose: diagnostic (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Blinding: single (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 16 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past trials: 107 (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- diagnostic (typical: treatment)
- Blinding
- single (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 107 (typical: 32)
- Sponsor's past termination rate
- 21.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 16 (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
- BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects NCT00856843 · started 2009 · scored riskier than 6% of active trials completed
- A Safety Study of 3 Different Bowel Cleansing Preparations NCT01501513 · started 2011 · scored riskier than 6% of active trials completed
- A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy NCT03404401 · started 2018 · scored riskier than 9% of active trials completed
- A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy NCT03261960 · started 2017 · scored riskier than 12% of active trials completed
- BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy NCT00756977 · started 2008 · scored riskier than 6% 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.