Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
Model scores of the 29,894 trials active now.
Model score 7% 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 17% of the time (213 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-04-03, after 2015-10-31 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 2018-04-03. 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: activediseasebowelmalignancyremission
Phrases that lowered it: the efficacyefficacy andand safetyto investigateinvestigate the -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 11.4% (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 56.5% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 3.5% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: quadruple (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 18 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, neurology: No (lowers risk) · Disease area
-
Maximum age: 75 (raises risk) · Who can join
-
Number of arms: 2 (raises 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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (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
- 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
- 114 (typical: 32)
- Sponsor's past termination rate
- 11.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 18 (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
- 17562 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4869 (typical: 412.5)
- Drug's FAERS reports marked serious
- 56.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 3.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- mesalamine
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
- Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC) NCT02522780 · started 2016 · scored riskier than 10% of active trials completed
- A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis NCT01045018 · started 2008 · scored riskier than 16% of active trials completed
- (CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets NCT01100112 · started 2010 · scored riskier than 10% of active trials completed
- Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis NCT01059344 · started 2009 · scored riskier than 17% of active trials completed
- Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase NCT01257399 · started 2010 · scored riskier than 11% 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.