Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (734 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 2011-11-30, after 2010-09-30 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 2011-11-30. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: mricontrastcnsimagingpatients must
Phrases that lowered it: participatedsafetyefficacyresultsaged -
Sponsor's past termination rate: 33.3% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports with a death: 9% (lowers risk) · Drug's FDA history
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Blinding: quadruple (lowers risk) · Design
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Has a data monitoring committee: No (lowers risk) · Design
-
Minimum age: 2 (lowers risk) · Who can join
-
Primary purpose: diagnostic (raises risk) · Design
-
Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
-
Number of arms: 3 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 8 (raises 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
- 3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- 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
- 5 (typical: 1)
Who can join
- Minimum age
- 2 (typical: 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
- 6 (typical: 32)
- Sponsor's past termination rate
- 33.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 8 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 200 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 55 (typical: 412.5)
- Drug's FAERS reports marked serious
- 81% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- gadolinium, gadopentetate dimeglumine, gadoterate
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
- A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Known or Suspected Brain or Spinal Cord-related Problems NCT05915702 · started 2023 · scored riskier than 19% of active trials completed
- A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems) NCT05915728 · started 2023 · scored riskier than 30% 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
- 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
- Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children NCT06010173 · started 2023 · scored riskier than 23% 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.