Growth Hormone or Sildenafil as Therapies for Fatigue in Mild- Traumatic-brain-injury (MTBI)
Model scores of the 29,894 trials active now.
Model score 14% 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 14% of the time (201 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
Completed on 2017-11-10, after 2014-12-12 start.
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 2017-11-10. 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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Sponsor's past termination rate: 34.8% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: hormoneinjuryto assessuse ofdisease
Phrases that lowered it: subjects whocrossoverdrugblood pressuredaily -
Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Primary purpose: diagnostic (lowers risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Drug's FAERS reports marked serious: 66.2% (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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Drug's FAERS reports with a death: 17.2% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Keywords listed: 5 (lowers risk) · Design
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Drug's FAERS reports before start: 40413 (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 16 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 23 (lowers risk) · Sponsor's track record
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Maximum age: 60 (lowers 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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- diagnostic (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 60 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 23 (typical: 32)
- Sponsor's past termination rate
- 34.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 16 (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
- 40413 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 10907 (typical: 412.5)
- Drug's FAERS reports marked serious
- 66.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- 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
- Growth Hormone and Brain Functioning After Traumatic Brain Injury NCT01699308 · started 2009 · scored riskier than 57% of active trials completed
- Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury. NCT00766038 · started 2008 · scored riskier than 63% of active trials completed
- Sildenafil for Cerebrovascular Dysfunction in Chronic Traumatic Brain Injury. NCT01762475 · started 2013 · scored riskier than 36% of active trials completed
- Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults With Growth Hormone Deficiency NCT01007071 · started 2009 · scored riskier than 76% of active trials completed
- Hormone Treatment in Growth Hormone and Testosterone Deficient Patients NCT01397500 · started 2011 · scored riskier than 34% of active trials terminated
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.