Effect of Aspirin on Gut Microbiome
Model scores of the 29,894 trials active now.
Model score 8% 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 11% of the time (918 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-08-29, after 2016-08-31 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 2018-08-29. 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
-
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 79 (lowers risk) · Sponsor's track record
-
Blinding: quadruple (lowers risk) · Design
-
Drug's FAERS reports with a death: 9.5% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 50 (lowers risk) · Who can join
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Maximum age: 75 (raises risk) · Who can join
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Sponsor's past termination rate: 7.5% (raises risk) · Sponsor's track record
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Primary purpose: basic science (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cancerheartgreaterattackplacebo
Phrases that lowered it: healthykggastrointestinalsubjectsaged -
Keywords listed: 5 (lowers risk) · Design
-
Drug's FAERS reports before start: 287971 (lowers risk) · Drug's FDA history
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 50 (typical: 18)
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 240 (typical: 32)
- Sponsor's past termination rate
- 7.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 79 (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
- 287971 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 56672 (typical: 412.5)
- Drug's FAERS reports marked serious
- 72.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- aspirin
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
- Trial of Aspirin and Arginine Restriction in Colorectal Cancer NCT00578721 · started 2008 · scored riskier than 94% of active trials completed
- Aquamin and Prevention of Colon Cancer NCT02647671 · started 2016 · scored riskier than 59% of active trials completed
- A Randomized, 2x2 Factorial Design Biomarker Prevention Trial of Low-dose ASA and Metformin in Stage I-III Crc Patients NCT03047837 · started 2017 · scored riskier than 57% 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
- Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis NCT03998488 · started 2020 · scored riskier than 36% 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.