Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (493 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2020-09-30, after 2017-04-18 start.
Reason given by the sponsor: “safety”
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 2020-09-30. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 18.7% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: term safetylong termcompletedtolerabilitystudies
Phrases that lowered it: patients whothe investigatorsafety ofpatients withdrug -
Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: no FAERS history (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: 52 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, respiratory: Yes (raises risk) · Disease area
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Sponsor's past trials: 225 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
-
Disease area, neurology: No (lowers risk) · Disease area
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Collaborators: 0 (raises 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
- 18
- Maximum age
- 85 (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
- 225 (typical: 32)
- Sponsor's past termination rate
- 18.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 52 (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
- cardiovascular, respiratory
- Drugs matched to FDA substances
- bardoxolone methyl
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
- An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) NCT03749447 · started 2019 · scored riskier than 58% of active trials terminated
- Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients NCT00990314 · started 2009 · scored riskier than 73% of active trials completed
- Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST NCT02657356 · started 2016 · scored riskier than 92% of active trials terminated
- A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension NCT03657095 · started 2018 · scored riskier than 69% of active trials terminated
- An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients NCT00792571 · started 2009 · scored riskier than 56% 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.