Sildenafil Treatment for Mild TBI
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (446 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2019-05-29, after 2018-07-25 start.
Reason given by the sponsor: “other”
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 2019-05-29. 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: injurypostuse ofimagingbrain
Phrases that lowered it: the efficacydegenerationbloodmalemild -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 14.6% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 72 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports marked serious: 65.3% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports with a death: 16.3% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Disease area, neurology: Yes (raises risk) · Disease area
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Blinding: double (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Responsible party: principal investigator (lowers risk) · Design
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Sponsor's past trials: 240 (lowers risk) · Sponsor's track record
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- 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
- 35 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 240 (typical: 32)
- Sponsor's past termination rate
- 14.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 72 (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
- 75503 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 8902 (typical: 412.5)
- Drug's FAERS reports marked serious
- 65.3% (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
- Sildenafil for Cerebrovascular Dysfunction in Chronic Traumatic Brain Injury. NCT01762475 · started 2013 · scored riskier than 36% of active trials completed
- Cerebrovascular Reactivity in American Football Players NCT03417492 · started 2018 · scored riskier than 38% of active trials terminated
- Cerebrovascular Reactivity Assessed With fNIRS as a Biomarker of TCVI After Acute Traumatic Brain Injury in Military NCT04058132 · started 2019 · scored riskier than 26% of active trials terminated
- Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits NCT01000064 · started 2009 · scored riskier than 52% of active trials terminated
- Use of Resveratrol to Decrease Acute Secondary Brain Injury Following Sports-Related Concussions in Boxers NCT01321151 · started 2011 · scored riskier than 18% 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.