Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 6% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-09-11, after 2019-06-03 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2020-09-11. 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: 16.7% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cnsmriacuteimagingcentral nervous
Phrases that lowered it: and safetyefficacy andsafety ofto evaluateevaluate the -
Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports marked serious: 37.4% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 2.0% (lowers risk) · Drug's FDA history
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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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Primary purpose: diagnostic (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Blinding: quadruple (lowers 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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- diagnostic (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (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
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 24 (typical: 32)
- Sponsor's past termination rate
- 16.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (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
- 3183 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 421 (typical: 412.5)
- Drug's FAERS reports marked serious
- 37.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- gadobutrol, gadopiclenol
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
- Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging NCT01660841 · started 2012 · scored riskier than 21% of active trials completed
- Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging NCT00709852 · started 2008 · scored riskier than 38% of active trials completed
- Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) NCT03986138 · started 2019 · scored riskier than 52% of active trials completed
- P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) NCT02633501 · started 2016 · scored riskier than 60% of active trials completed
- Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas NCT06057168 · started 2023 · scored riskier than 54% 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.