Diclofenac for Submassive PE
Model scores of the 29,894 trials active now.
Model score 21% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 7% of the time (56 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 2017-06-30, after 2012-05-31 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 2017-06-30. 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: scanventricularpatients withacutesymptomatic
Phrases that lowered it: asthmaplaceboclinicalclinically relevanttrial -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
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Design: single group (raises risk) · Design
-
Responsible party: principal investigator (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
-
Blinding: double (raises risk) · Design
-
Drug's FAERS reports with a death: 12.0% (lowers risk) · Drug's FDA history
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Phase: 2/3 (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
-
Sponsor type: government (raises risk) · Sponsor's track record
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
-
Number of arms: 2 (raises risk) · Design
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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
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (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
- government (typical: academic or other)
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 19569 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3785 (typical: 412.5)
- Drug's FAERS reports marked serious
- 88.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, respiratory
- Drugs matched to FDA substances
- diclofenac
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 Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism NCT02923115 · started 2016 · scored riskier than 91% of active trials completed
- Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients NCT01516814 · started 2012 · scored riskier than 12% of active trials completed
- Clot Dissolving Treatment for Blood Clots in the Lungs NCT00680628 · started 2008 · scored riskier than 98% of active trials terminated
- Air Versus Oxygen for Intermediate-Risk Pulmonary Embolism (AIRE) NCT04003116 · started 2019 · scored riskier than 92% of active trials completed
- Thrombolysis Endovascular Treatment of Pulmonary Embolism NCT03966079 · started 2017 · scored riskier than 90% 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.