A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 6% 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
Terminated on 2023-10-10, after 2023-02-21 start.
Reason given by the sponsor: “business”
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 2023-10-10. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: placeboscreeningpurpose ofthe purposesurgery
Phrases that lowered it: participantsparticipantweeksresection200 -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Sponsor's past termination rate: 11.6% (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 25.8% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports with a death: 1.6% (lowers risk) · Drug's FDA history
-
Blinding: triple (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 117 (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor's past trials: 551 (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (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
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 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
- 551 (typical: 32)
- Sponsor's past termination rate
- 11.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 117 (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
- 14309 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5283 (typical: 412.5)
- Drug's FAERS reports marked serious
- 25.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- guselkumab
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 Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence NCT01190839 · started 2010 · scored riskier than 53% of active trials terminated
- Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease NCT01564823 · started 2012 · scored riskier than 35% of active trials completed
- Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease NCT01951326 · started 2013 · scored riskier than 54% of active trials completed
- A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease NCT04397263 · started 2020 · scored riskier than 16% of active trials completed
- A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery NCT03943446 · started 2020 · scored riskier than 54% of active trials terminated
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.