Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
Model scores of the 29,894 trials active now.
Model score 8% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2019-04-10, after 2017-11-24 start.
Reason given by the sponsor: “enrollment”
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 2019-04-10. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: kidneycolorectalfailureplacebosubject
Phrases that lowered it: patientspresenceclinical studydiseaseshormone -
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Collaborators: 6 (lowers risk) · Design
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Phase: 2 (raises risk) · Design
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Minimum age: 25 (lowers risk) · Who can join
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Responsible party: sponsor investigator (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: 60.7% (lowers risk) · Drug's FDA history
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Primary purpose: prevention (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Number of arms: 3 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 3.9% (lowers risk) · Drug's FDA history
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Blinding: double (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
- 2
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 6 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 25 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (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
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 27008 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3965 (typical: 412.5)
- Drug's FAERS reports marked serious
- 60.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 3.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive, metabolic
- Drugs matched to FDA substances
- aminosalicylic acid, 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
- Mesalazine Effects in Sporadic Colorectal Adenoma Patients NCT01894685 · started 2012 · scored riskier than 57% of active trials completed
- A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis NCT01805791 · started 2013 · scored riskier than 68% of active trials terminated
- HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis NCT01882764 · started 2013 · scored riskier than 79% of active trials terminated
- 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
- Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis NCT01149707 · started 2010 · scored riskier than 26% 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.