ASpirin for Patients With SEPsis and SeptIc Shock
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (331 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-01-05, after 2019-03-27 start.
Reason given by the sponsor: “safety”
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 2023-01-05. 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: injuryhourssurgeryorgansepsis
Phrases that lowered it: evaluatedaysafety ofthe effecteffect of -
Sponsor's past termination rate: 1.4% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 30 (lowers risk) · Sponsor's track record
-
Blinding: quadruple (lowers risk) · Design
-
Responsible party: principal investigator (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 9.6% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor's past trials: 211 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 2 (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
-
Drug's FAERS reports before start: 441472 (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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 4 (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
- academic or other
- Sponsor's past trials
- 211 (typical: 32)
- Sponsor's past termination rate
- 1.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 30 (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
- 441472 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 61912 (typical: 412.5)
- Drug's FAERS reports marked serious
- 72.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- 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
- Co-administration of Iloprost and Eptifibatide in Septic Shock Patients NCT02204852 · started 2014 · scored riskier than 73% of active trials completed
- Does Acetylsalicylic Acid Reduce the Mortality of Patients Admitted to an Intensive Care Unit NCT02285153 · started 2011 · scored riskier than 81% of active trials terminated
- ASpirin as a Treatment for ARDS (STAR): a Phase 2 Randomised Control Trial NCT02326350 · started 2015 · scored riskier than 74% of active trials terminated
- Integrilin and Ilomedin in Combination in Comparison to Standard Treatment in Severe Pneumonia Patients With Severe Sepsis NCT01532544 · started 2012 · scored riskier than 71% of active trials terminated
- Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery NCT04291508 · started 2021 · scored riskier than 99% 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.