Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children

NCT01237041 on ClinicalTrials.gov Phase 1/2 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (government) Started 2011-07-01 Terminated

Riskier than 6% of active trials

Model scores of the 29,894 trials active now.

Model score 6% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 18% of the time (243 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 2017-12-13, after 2011-07-01 start.

Reason given by the sponsor: “other”

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 2017-12-13. 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

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Sponsor's past termination rate: 4.0% (lowers risk) · Sponsor's track record
Phase: 1/2 (raises risk) · Design
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: breastgrowthmg dlhormonefree
Phrases that lowered it: weightbloodkgbodysubjects
Disease area, neurology: Yes (raises risk) · Disease area
Drug's FAERS reports marked serious: 58.5% (lowers risk) · Drug's FDA history
Blinding: quadruple (lowers risk) · Design
Primary purpose: diagnostic (lowers risk) · Design
Number of arms: 5 (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: government (lowers risk) · Sponsor's track record
Sponsor's past trials: 124 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 5.9% (lowers risk) · Drug's FDA history
Disease area, psychiatry: No (lowers risk) · Disease area
Responsible party: principal investigator (lowers risk) · Design
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: 1/2 (typical: 2)
Number of arms: 5 (typical: 2)
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: diagnostic (typical: treatment)
Blinding: quadruple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 0
Keywords listed: 9 (typical: 1)

Who can join

Minimum age: 7 (typical: 18)
Maximum age: 14 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: government (typical: academic or other)
Sponsor's past trials: 124 (typical: 32)
Sponsor's past termination rate: 4.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 9 (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: 7839 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1458 (typical: 412.5)
Drug's FAERS reports marked serious: 58.5% (typical: 85.6%)
Drug's FAERS reports with a death: 5.9% (typical: 15.9%)

Disease area and drugs

Disease areas: neurology, metabolic, musculoskeletal, endocrine
Drugs matched to FDA substances: niacin

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

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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.