Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 19% of the time (90 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2019-11-08, after 2016-05-21 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 2019-11-08. 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: brainenrollmentassociatedlivergrowth
Phrases that lowered it: kgevaluateperioddaylipid -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Collaborators: 4 (lowers risk) · Design
-
Sponsor's past termination rate: 11.2% (raises risk) · Sponsor's track record
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Primary purpose: prevention (lowers risk) · Design
-
Phase: 3 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 100 (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor's past trials: 330 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 93.2% (raises risk) · Drug's FDA history
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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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Drug's FAERS reports with a death: 21.8% (raises risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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Maximum age: 1 (raises risk) · Who can join
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
- prevention (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 4 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 1 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 330 (typical: 32)
- Sponsor's past termination rate
- 11.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 100 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 468 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 155 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- phospholipid, soybean 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
- Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates NCT03387579 · started 2018 · scored riskier than 95% of active trials completed
- SMOFlipid to Lessen the Severity of Neonatal Cholestasis NCT02721277 · started 2016 · scored riskier than 37% of active trials terminated
- Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children NCT01194063 · started 2010 · scored riskier than 35% of active trials completed
- Compassionate Use of Omegaven IV Fat Emulsion NCT00816348 · started 2008 · scored riskier than 88% of active trials terminated
- Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury NCT01845116 · started 2010 · scored riskier than 89% 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.