Topical 3% Amphotericin B Cream for the Treatment of Cutaneous Leishmaniasis in Colombia
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 7% of the time (96 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 2016-07-31, after 2014-02-28 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 2016-07-31. 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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Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjectsubjectspharmacokinetics andcmlesion
Phrases that lowered it: dayefficacytimessafety ofweeks -
Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 38.4% (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 97.1% (raises risk) · Drug's FDA history
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Blinding: none (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Disease area, dermatology: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Disease area, infectious disease: Yes (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 4 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 12 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers 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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (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
- 12 (typical: 32)
- Sponsor's past termination rate
- 16.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (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
- 2279 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 235 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 38.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, dermatology
- Drugs matched to FDA substances
- amphotericin b
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
- Phase 3 Study to Evaluate WR 279,396 vs. Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia) NCT00606580 · started 2008 · scored riskier than 31% of active trials completed
- Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis NCT02656797 · started 2018 · scored riskier than 70% of active trials completed
- WR 279,396 for the Treatment of Cutaneous Leishmaniasis NCT01988909 · started 2013 · scored riskier than 62% of active trials completed
- High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus NCT01953744 · started 2014 · scored riskier than 51% of active trials terminated
- WR 279,396 Open Label Treatment Protocol in Tunisia NCT01494350 · started 2011 · scored riskier than 29% 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.