A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis
Model scores of the 29,894 trials active now.
Model score 15% 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 6% of the time (876 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 2011-11-30, after 2010-12-31 start.
Reason given by the sponsor: “other”
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 2011-11-30. 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: 14.8% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Primary purpose: not given (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 397 (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 24.5% (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Sponsor's past trials: 854 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: greater thaninvasivepresence ofsafetreatment of
Phrases that lowered it: and safetyefficacy andsubjects whosafety ofpatients -
Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 92.7% (raises risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Maximum age: not given (raises 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
- 1 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- not given (typical: 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
- 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
- 854 (typical: 32)
- Sponsor's past termination rate
- 14.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 397 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 9222 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1632 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- anidulafungin, fluconazole
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
- Anidulafungin In Treatment Of Candidemia In Asian Subjects NCT00537329 · started 2008 · scored riskier than 72% of active trials completed
- Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis NCT00761267 · started 2009 · scored riskier than 36% of active trials completed
- Anidulafungin in Patients With Hematologic Malignancies NCT01053884 · started 2009 · scored riskier than 45% of active trials terminated
- A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole NCT05178862 · started 2022 · scored riskier than 62% of active trials terminated
- An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia NCT03604705 · started 2018 · 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.