Phenotypical Approach of the Drug Metabolizing Hormones Activity Before and After Roux-en Y-Gastric Bypass
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (137 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 2014-02-28, after 2011-09-30 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 2014-02-28. 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
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Sponsor's past termination rate: 22.1% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 156 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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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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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Sponsor's past trials: 190 (lowers risk) · Sponsor's track record
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Maximum age: 60 (lowers risk) · Who can join
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Keywords listed: 5 (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: bypassobesitysurgeryhoursprimary
Phrases that lowered it: aimgastricprotocol12periods -
Collaborators: 1 (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
- 1 (typical: 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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 60 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 190 (typical: 32)
- Sponsor's past termination rate
- 22.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 156 (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
- metabolic
- 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
- Effects of Gastric Bypass on Blood Levels of Duloxetine NCT00989157 · started 2009 · scored riskier than 3% of active trials completed
- CREON for the Treatment of Post-RYGB Hypoglycemia NCT02733848 · started 2014 · scored riskier than 10% of active trials terminated
- Rivaroxaban Effects in Subjects Who Have Undergone Gastric Bypass Surgery NCT02058199 · started 2014 · scored riskier than 11% of active trials terminated
- Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery NCT01214382 · started 2010 · scored riskier than 10% of active trials completed
- Study to Examine the Effect of Gastric Bypass Surgery on Venlafaxine ER Blood Levels NCT01867255 · started 2013 · scored riskier than 47% 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.