Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (1,463 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 2014-02-28, after 2011-01-31 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 2014-02-28. 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) (raises risk) · Wording
Phrases that raised it: subjectsplacebosubjectprostatemetastases
Phrases that lowered it: participantssafety ofboneevaluate theto evaluate -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Sponsor's past termination rate: 5% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Drug's FAERS reports with a death: 9.3% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 85 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 200 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Disease area, neurology: No (lowers risk) · Disease area
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Collaborators: 0 (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports marked serious: 92.7% (raises risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 146 (raises risk) · Drug's FDA history
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
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 200 (typical: 32)
- Sponsor's past termination rate
- 5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 85 (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
- 150 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 146 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- denosumab
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
- Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only NCT00950911 · started 2009 · scored riskier than 7% of active trials completed
- Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer NCT00838201 · started 2009 · scored riskier than 10% of active trials completed
- Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer NCT01419717 · started 2011 · scored riskier than 18% of active trials completed
- Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant NCT03925532 · started 2019 · scored riskier than 99% of active trials completed
- Reduced Dose-density of Denosumab for Unresectable GCTB NCT03620149 · started 2019 · scored riskier than 87% 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.