Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (803 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2019-07-23, after 2016-08-16 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 2019-07-23. 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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Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 14.5% (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: ulnevidencecreatininemetastaseslimit
Phrases that lowered it: open labeltabletsingleefficacystudy to -
Drug's FAERS reports with a death: 34.3% (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 187 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 915 (raises 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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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Maximum age: not given (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 91.1% (raises risk) · Drug's FDA history
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Minimum age: 10 (lowers risk) · Who can join
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Blinding: none (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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 11 (typical: 1)
Who can join
- Minimum age
- 10 (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
- 915 (typical: 32)
- Sponsor's past termination rate
- 14.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 187 (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
- 17457 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2187 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 34.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, hematology
- Drugs matched to FDA substances
- deferasirox
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
- Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet) NCT02125877 · started 2014 · scored riskier than 41% of active trials completed
- Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload NCT02435212 · started 2015 · scored riskier than 57% of active trials completed
- Open-label, Multicenter Study Assessing Preference for Deferasirox Film-coated Tablet Compared to Dispersible Tablet NCT02993224 · started 2017 · scored riskier than 63% of active trials completed
- Characterisation of Relative Bioavailability With Bioequivalence Assessment of Deferiprone Tablets After Oral Single Dose Administration NCT02980458 · started 2016 · scored riskier than 0% of active trials completed
- Comparison of Deferiprone Extended Release Tablets and Ferriprox Immediate Release Tablets in Healthy Volunteers NCT02465489 · started 2015 · scored riskier than 0% 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.