Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep®
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 16% of the time (370 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-07-16, after 2020-06-18 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 2021-07-16. 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: patientpatientsmonthsstandardm2
Phrases that lowered it: gastrointestinalefficacyand safetysafety ofpreparation -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Number of arms: 5 (lowers risk) · Design
-
Drug's FAERS reports marked serious: 45.6% (lowers risk) · Drug's FDA history
-
Blinding: single (lowers risk) · Design
-
Phase: 2/3 (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 6.1% (lowers risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: diagnostic (lowers 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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Has a data monitoring committee: No (lowers risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Drug's FAERS reports in the prior 12 months: 13344 (raises 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
- 2/3 (typical: 2)
- Number of arms
- 5 (typical: 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
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (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
- 4 (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
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 120445 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 13344 (typical: 412.5)
- Drug's FAERS reports marked serious
- 45.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, dermatology
- Drugs matched to FDA substances
- ascorbate, polyethylene glycol
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
- Safety and Efficacy Study of an Edible Colonoscopy Preparation NCT03332485 · started 2017 · scored riskier than 8% of active trials completed
- Efficacy and Safety of Oral Sulfate Solution on Bowel Preparation for Colonoscopy NCT05465889 · started 2019 · scored riskier than 6% of active trials completed
- Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation NCT01732692 · started 2012 · scored riskier than 41% of active trials completed
- Efficacy Study of Bowel Preparation Before Colonoscopy NCT00621920 · started 2008 · scored riskier than 7% of active trials completed
- 2 Regimens of Lactulose for Colonoscopy Preparation in Adults NCT01887470 · started 2013 · 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.