Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary 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 13% of the time (1,304 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-03-21, after 2015-02-03 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 2022-03-21. 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 termextensionin subjectscompletedsubjects with
Phrases that lowered it: aminotransferasepulmonaryhypertensionchronicthromboembolic -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Design: single group (raises risk) · Design
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Drug's FAERS reports marked serious: 75.7% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 22.4% (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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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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Minimum age: 18 (raises risk) · Who can join
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Blinding: none (raises risk) · Design
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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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Sponsor's past trials: 60 (lowers risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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Collaborators: 0 (raises risk) · Design
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Maximum age: not given (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
- 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
- 1
Who can join
- Minimum age
- 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
- 60 (typical: 32)
- Sponsor's past termination rate
- 16.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 15 (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
- 2371 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2277 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- 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
- Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension NCT02021292 · started 2014 · scored riskier than 52% of active trials completed
- A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Hypertension Who Were Previously Treated With Macitentan in Clinical Studies. NCT03422328 · started 2018 · scored riskier than 24% of active trials completed
- A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH). NCT03809650 · started 2019 · scored riskier than 17% of active trials terminated
- A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension NCT04271475 · started 2020 · scored riskier than 53% of active trials terminated
- A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) NCT01894022 · started 2014 · scored riskier than 72% 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.