Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)
Model scores of the 29,894 trials active now.
Model score 26% 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 18% of the time (280 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
Terminated on 2016-04-30, after 2013-07-31 start.
Reason given by the sponsor: “enrollment”
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 2016-04-30. 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: patientpatientslong termthe longtumor
Phrases that lowered it: colitissinglerelevantulcerativeuc -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Sponsor's past trials: 716 (raises risk) · Sponsor's track record
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Sponsor's past termination rate: 12.0% (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: single group (raises risk) · Design
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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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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Trials the sponsor started in the prior 2 years: 105 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports in the prior 12 months: 0 (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Keywords listed: 0 (lowers risk) · Design
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Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
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Collaborators: 0 (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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (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
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 716 (typical: 32)
- Sponsor's past termination rate
- 12.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 105 (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
- digestive
- 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
- Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis NCT01461317 · started 2011 · scored riskier than 50% of active trials completed
- Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis NCT01659138 · started 2012 · scored riskier than 60% of active trials terminated
- Long-Term Safety Of PF-00547659 In Ulcerative Colitis NCT01771809 · started 2013 · scored riskier than 86% of active trials completed
- An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis NCT03290781 · started 2018 · scored riskier than 36% of active trials completed
- TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC) NCT01903252 · started 2013 · scored riskier than 16% 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.