Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days
Model scores of the 29,894 trials active now.
Model score 2% 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 2008-08-31, after 2008-01-31 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 2008-08-31. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: effectspurposenoncardiacextensive
Phrases that lowered it: volunteershealthymaleparticipation inday -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: crossover (lowers risk) · Design
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Primary purpose: prevention (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Minimum age: 20 (lowers risk) · Who can join
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor's past termination rate: 7.5% (lowers risk) · Sponsor's track record
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Responsible party: not given (raises risk) · Design
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Drug's FAERS reports with a death: 13.0% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 4 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 207 (lowers risk) · Sponsor's track record
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Maximum age: 60 (lowers risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: double (raises 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 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- prevention (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 60 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 372 (typical: 32)
- Sponsor's past termination rate
- 7.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 207 (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
- 679 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 201 (typical: 412.5)
- Drug's FAERS reports marked serious
- 83.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- moxifloxacin
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
- Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers NCT00777361 · started 2008 · scored riskier than 2% of active trials terminated
- To Evaluate the Effect of AZD3199 on the Electrical Activity in the Heart NCT01222442 · started 2010 · scored riskier than 4% of active trials completed
- AZD3293 Thorough QT Study in Healthy Male Volunteers NCT02040987 · started 2014 · scored riskier than 23% of active trials completed
- Pharmacokinetic Interaction Between AZD3480 and Donepezil NCT00713765 · started 2008 · scored riskier than 3% of active trials terminated
- A Study to Investigate the Potential for AZD5672 to Affect the Electrical Conduction Pathways in the Heart NCT00887770 · started 2009 · scored riskier than 3% 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.