Fish Oil Study for High Triglyceride Levels in Children
Model scores of the 29,894 trials active now.
Model score 11% 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 6% of the time (48 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 2012-09-30, after 2009-07-31 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 2012-09-30. 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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Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Collaborators: 3 (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: highmg dltriglyceridesloweringcholesterol
Phrases that lowered it: childrenmaleclinicaladolescentstrial -
Phase: 2/3 (raises risk) · Design
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Responsible party: sponsor investigator (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Maximum age: 17 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 95% (raises risk) · Drug's FDA history
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Blinding: triple (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Sponsor's past termination rate: no earlier finished trials (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 15% (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Minimum age: 10 (raises risk) · Who can join
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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
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 3 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 10 (typical: 18)
- Maximum age
- 17 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- 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
- 0 (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
- 20 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 13 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95% (typical: 85.6%)
- Drug's FAERS reports with a death
- 15% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic
- Drugs matched to FDA substances
- corn oil, omega3 acid ethyl esters
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 Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides NCT00672633 · started 2008 · scored riskier than 19% of active trials terminated
- Study of Fish Oil to Reduce ALT Levels in Adolescents NCT00694746 · started 2008 · scored riskier than 20% of active trials terminated
- Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia NCT00959842 · started 2009 · scored riskier than 16% of active trials completed
- Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults NCT03043365 · started 2017 · scored riskier than 6% of active trials completed
- Epanova® for Lowering Very High Triglycerides II (EVOLVE II) NCT02009865 · started 2013 · scored riskier than 32% 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.