FST-201 In The Treatment of Acute Otitis Externa
Model scores of the 29,894 trials active now.
Model score 10% 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 10% of the time (1,463 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
Terminated on 2010-07-31, after 2009-07-31 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 2010-07-31. 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
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: acutechronicsurgeryhepatitisinfection
Phrases that lowered it: dexamethasonethe efficacytopicalvisitevaluate the -
Phase: 3 (lowers risk) · Design
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Sponsor's past termination rate: 6.4% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 30 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports with a death: 19.1% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 89.5% (raises risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports before start: 17324 (raises risk) · Drug's FDA history
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Sponsor's past trials: 78 (lowers risk) · Sponsor's track record
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
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 78 (typical: 32)
- Sponsor's past termination rate
- 6.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 30 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 17324 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4436 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ciprofloxacin, ciprofloxacin dexamethasone, dexamethasone
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
- FST-201 in the Treatment of Acute Otitis Externa NCT00961675 · started 2009 · scored riskier than 12% of active trials completed
- A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa NCT01910155 · started 2013 · scored riskier than 13% of active trials terminated
- FST-201 In The Treatment of Acute Fungal Otitis Externa NCT00945646 · started 2009 · scored riskier than 12% of active trials terminated
- Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes NCT01994642 · started 2013 · scored riskier than 12% of active trials terminated
- A Phase III Study of an Otic Formulation in Acute Otitis Externa NCT00750633 · started 2008 · scored riskier than 42% 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.