An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
Model scores of the 29,894 trials active now.
Model score 25% 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 6% of the time (528 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 2021-08-12, after 2013-09-11 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 2021-08-12. 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: long termterm safetyextensionthe longcompleted
Phrases that lowered it: study medicationdaysoralthe studyused -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 29.2% (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 46.7% (raises risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Phase: 3 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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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's past trials: 24 (lowers risk) · Sponsor's track record
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Drug's FAERS reports before start: 6349 (lowers risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 98.2% (raises risk) · Drug's FDA history
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Disease area, respiratory: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 8 (raises risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 1347 (lowers risk) · Drug's FDA history
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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
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (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
- 29.2% (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
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 6349 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1347 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 46.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory
- Drugs matched to FDA substances
- treprostinil, treprostinil diolamine
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 of Oral Treprostinil in Subjects With PH Associated With HFpEF NCT03043651 · started 2018 · scored riskier than 51% of active trials terminated
- Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension NCT00887978 · started 2009 · scored riskier than 58% of active trials completed
- An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE NCT02633293 · started 2016 · scored riskier than 81% of active trials terminated
- Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso® NCT01477333 · started 2011 · scored riskier than 87% of active trials completed
- Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD) NCT03794583 · started 2018 · scored riskier than 22% 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.