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Inorganic Nitrate: Sex Differences in Muscle Contractile Function and Efficiency

NCT04588740 on ClinicalTrials.gov Phase 1 University of Virginia (academic or other) Started 2020-01-20 Completed
Riskier than 3% of active trials
this trial: 4% 0% 36%

Model scores of the 29,894 trials active now.

Model score 4% 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 11% of the time (918 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2023-12-30, after 2020-01-20 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

0% 24% 47% 71% 95% 0123456 yr completed 82% terminated 10%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2023-12-30. 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

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 (typical: 2)
Number of arms
2
Allocation
randomized
Design
crossover (typical: parallel)
Primary purpose
other (typical: 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
34 (typical: 71)
Sex
all
Accepts healthy volunteers
Yes (typical: 9% yes)

Sponsor's track record

Sponsor type
academic or other
Sponsor's past trials
177 (typical: 32)
Sponsor's past termination rate
11.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
62 (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
6 (typical: 2148)
Drug's FAERS reports in the prior 12 months
2 (typical: 412.5)
Drug's FAERS reports marked serious
66.7% (typical: 85.6%)
Drug's FAERS reports with a death
0% (typical: 15.9%)

Disease area and drugs

Disease areas
none of the 14 tracked areas
Drugs matched to FDA substances
beet

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

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.