Safety and Efficacy Study of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy.
Model scores of the 29,894 trials active now.
Model score 6% for any early termination, 4% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2011-02-28, after 2010-01-31 start.
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 2011-02-28. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: abdominalundergoingperforationactiveprior
Phrases that lowered it: subjectsthe studyexaminationbetween 1818 and -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Primary purpose: not given (lowers risk) · Design
-
Phase: 3 (lowers risk) · Design
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 11.6% (lowers risk) · Drug's FDA history
-
Responsible party: not given (raises risk) · Design
-
Blinding: single (lowers risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, neurology: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: 78.8% (lowers risk) · Drug's FDA history
-
Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Number of arms: 3 (lowers 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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- not given (typical: treatment)
- Blinding
- single (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 80 (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
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 6 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 56923 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 12857 (typical: 412.5)
- Drug's FAERS reports marked serious
- 78.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- bicarbonate, citric acid, oxide, picosulfate, polyethylene glycol, polyethylene glycols
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
- A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy NCT03017235 · started 2017 · scored riskier than 21% of active trials completed
- Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep NCT01073930 · started 2010 · scored riskier than 21% of active trials completed
- Safety and Efficacy Study of an Edible Colonoscopy Preparation NCT03332485 · started 2017 · scored riskier than 8% of active trials completed
- Efficacy Study of Bowel Preparation Before Colonoscopy NCT00621920 · started 2008 · scored riskier than 7% of active trials completed
- Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep NCT01073943 · started 2010 · scored riskier than 19% 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.