Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386
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 2009-02-28, after 2009-01-31 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 2009-02-28. 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: painhearttolerabilitycardiacmay interfere
Phrases that lowered it: healthyvolunteersand safetymalemetabolism -
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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Minimum age: 35 (lowers risk) · Who can join
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Design: single group (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Responsible party: not given (raises risk) · Design
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Blinding: none (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 306 (raises 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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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Sponsor's past termination rate: 7.2% (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
- 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
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 35 (typical: 18)
- Maximum age
- 50 (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
- 556 (typical: 32)
- Sponsor's past termination rate
- 7.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 306 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- none matched
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
- Investigation of Rate + Extent of Excretion of Radioactivity in Urine +Faeces After Oral Administration of [14C]AZD2066 NCT00829088 · started 2009 · scored riskier than 2% of active trials completed
- AZD0914 Phase 1 ADME Study in Healthy Volunteers NCT02298920 · started 2015 · scored riskier than 9% of active trials completed
- Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD9291 in Volunteers NCT02096679 · started 2014 · scored riskier than 1% of active trials completed
- Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers NCT01058447 · started 2010 · scored riskier than 3% of active trials completed
- Phase I Study to Assess Absorption, Metabolism & Excretion of a Single Oral Dose [14C]AZD0530 in Healthy Male Volunteers NCT00853983 · started 2009 · scored riskier than 4% 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.