A New Sildenafil Oral Film in Patients With Erectile Dysfunction
Model scores of the 29,894 trials active now.
Model score 8% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 12% of the time (422 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-12-09, after 2024-01-26 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
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-12-09. 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) (lowers risk) · Wording
Phrases that raised it: ischemiccorddisorderneuropathyleast months
Phrases that lowered it: and safetyefficacy andsafety ofthe efficacyclinical -
Sponsor's past termination rate: 4.2% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 15.2% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports marked serious: 67.1% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Blinding: double (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 5643 (raises risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Disease area, urogenital: Yes (raises risk) · Disease area
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Maximum age: not given (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 24 (typical: 32)
- Sponsor's past termination rate
- 4.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 114801 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5643 (typical: 412.5)
- Drug's FAERS reports marked serious
- 67.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 15.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry, urogenital
- 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
- Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older. NCT00655629 · started 2008 · scored riskier than 20% of active trials completed
- Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction NCT00631969 · started 2008 · scored riskier than 20% of active trials completed
- Efficacy and Safety of TPN171H in the Patients With Erectile Dysfunction NCT04479917 · started 2020 · scored riskier than 12% of active trials completed
- Safety and Efficacy of YHD1023 in Erectile Dysfunction NCT01423370 · started 2011 · scored riskier than 12% of active trials completed
- Effect of Tadalafil Once a Day in Men With Erectile Dysfunction NCT00836693 · started 2009 · scored riskier than 14% 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.