Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument
Model scores of the 29,894 trials active now.
Model score 16% 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
Terminated on 2017-11-30, after 2013-09-01 start.
Reason given by the sponsor: “other”
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 2017-11-30. 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
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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: extensionpahpregnancypulmonary arterialterm safety
Phrases that lowered it: singlelabelsafety ofarmopen -
Sponsor's past termination rate: 14.8% (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 4.2% (lowers risk) · Drug's FDA history
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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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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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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 24 (lowers risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Sponsor's past trials: 54 (lowers risk) · Sponsor's track record
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Disease area, respiratory: Yes (raises risk) · Disease area
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Number of arms: 1 (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
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 80 (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
- 54 (typical: 32)
- Sponsor's past termination rate
- 14.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 11 (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
- 91.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory
- Drugs matched to FDA substances
- macitentan
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
- Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH NCT02112487 · started 2014 · scored riskier than 67% of active trials completed
- Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument NCT01841762 · started 2013 · scored riskier than 36% of active trials completed
- Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension NCT00667823 · started 2008 · scored riskier than 91% of active trials completed
- A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain NCT02081690 · started 2014 · scored riskier than 46% of active trials terminated
- A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH) NCT02932410 · started 2017 · scored riskier than 79% 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.