Drug Interaction Study of Isavuconazole and Midazolam
Model scores of the 29,894 trials active now.
Model score 3% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 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 2011-06-30, after 2011-05-31 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 2011-06-30. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: inabilitypriorcancerto determinehours
Phrases that lowered it: healthythe pharmacokineticskgsubjectsopen label -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Primary purpose: not given (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: 5.7% (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Responsible party: not given (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 115 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor's past trials: 279 (lowers risk) · Sponsor's track record
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Maximum age: 55 (lowers risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: none (lowers risk) · Design
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Drug's FAERS reports marked serious: 90.4% (lowers risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- not given (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 279 (typical: 32)
- Sponsor's past termination rate
- 5.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 115 (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
- 3748 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 602 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- isavuconazole, midazolam
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
- Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects NCT01657838 · started 2012 · scored riskier than 1% of active trials completed
- A Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of Isavuconazole NCT02128893 · started 2014 · scored riskier than 2% of active trials completed
- Study of the Pharmacokinetics of Isavuconazole in Healthy Non-Elderly and Elderly Male and Female Subjects NCT01657890 · started 2012 · scored riskier than 2% of active trials completed
- Drug Interaction Study of Isavuconazole and Cyclosporine NCT01494597 · started 2011 · scored riskier than 2% of active trials completed
- Drug Interaction Study of Isavuconazole and Methadone NCT01582425 · started 2012 · scored riskier than 2% 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.