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Sildenafil Administration to Treat Neonatal Encephalopathy

NCT02812433 on ClinicalTrials.gov Phase 1 McGill University Health Centre/Research Institute of the McGill University Health Centre (academic or other) Started 2016-07-31 Completed
Riskier than 84% of active trials
this trial: 23% 0% 36%

Model scores of the 29,894 trials active now.

Model score 23% 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 18% of the time (141 trials).

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

How it ended

Completed on 2022-01-31, after 2016-07-31 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% 16% 32% 49% 65% 0123456 yr completed 56% terminated 21%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2022-01-31. 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
parallel
Primary purpose
treatment
Blinding
quadruple (typical: none)
Has a data monitoring committee
Yes (typical: 56% yes)
Responsible party
principal investigator (typical: sponsor)
Collaborators
0
Keywords listed
8 (typical: 1)

Who can join

Minimum age
not given (typical: 18)
Maximum age
not given (typical: 71)
Sex
all
Accepts healthy volunteers
No (typical: 9% yes)

Sponsor's track record

Sponsor type
academic or other
Sponsor's past trials
57 (typical: 32)
Sponsor's past termination rate
12.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
38 (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
56909 (typical: 2148)
Drug's FAERS reports in the prior 12 months
10114 (typical: 412.5)
Drug's FAERS reports marked serious
64.9% (typical: 85.6%)
Drug's FAERS reports with a death
16.3% (typical: 15.9%)

Disease area and drugs

Disease areas
cardiovascular, neurology
Drugs matched to FDA substances
sildenafil

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.