Efficacy and Safety of a Fish Oil Containing Lipid Emulsion
Model scores of the 29,894 trials active now.
Model score 6% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (1,463 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 2011-04-30, after 2010-04-30 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 2011-04-30. 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) (lowers risk) · Wording
Phrases that raised it: purpose offishabdominalcardiaccancer
Phrases that lowered it: efficacy andand safetylipidthe efficacysafety of -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports marked serious: 44.8% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports with a death: 2.8% (lowers risk) · Drug's FDA history
-
Blinding: quadruple (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 6 (raises risk) · Sponsor's track record
-
Number of arms: 2 (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
- 3 (typical: 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
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 85 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 7 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (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
- 5053 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2234 (typical: 412.5)
- Drug's FAERS reports marked serious
- 44.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- fish oil
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
- Efficacy and Safety of a PN Regimen Containing n-3 Fatty Acid in Patients Considered After GI Surgery NCT00798447 · started 2008 · scored riskier than 24% of active trials completed
- Efficacy & Safety of SmofKabiven Emulsion for Infusion vs Hospital Compounded All in One for Parenteral Nutrition NCT03792100 · started 2019 · scored riskier than 41% of active trials completed
- Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition NCT02663453 · started 2013 · scored riskier than 18% of active trials completed
- Compassionate Use of Omegaven in Children NCT02370251 · started 2015 · scored riskier than 36% of active trials completed
- Parenteral Nutrition With Intravenous and Oral Fish Oil for Intensive Care Patients NCT01162928 · started 2013 · scored riskier than 78% 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.