Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial Hypertension
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 7% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-12-05, after 2015-10-12 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 2016-12-05. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: pulmonaryhypertensionheartdiseaseleft
Phrases that lowered it: visitdays beforeinhaledrelevantthe study -
Sponsor's past termination rate: 15.9% (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 58.3% (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: 8.3% (lowers risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, respiratory: Yes (raises risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 16 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 63 (lowers risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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Maximum age: 75 (raises risk) · Who can join
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
- 0 (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
- 63 (typical: 32)
- Sponsor's past termination rate
- 15.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 16 (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
- 24 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 17 (typical: 412.5)
- Drug's FAERS reports marked serious
- 58.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory
- Drugs matched to FDA substances
- selexipag
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, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso NCT03950739 · started 2019 · scored riskier than 49% of active trials completed
- Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil NCT03399604 · started 2018 · scored riskier than 55% of active trials completed
- Beraprost-314d Added-on to Tyvaso® (BEAT) NCT01908699 · started 2013 · scored riskier than 90% of active trials completed
- Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso® NCT01477333 · started 2011 · scored riskier than 87% of active trials completed
- A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH) NCT04791514 · started 2022 · scored riskier than 44% 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.