Ambrisentan in Patients With Porto-pulmonary Hypertension A Multicenter Open Label Trial
Model scores of the 29,894 trials active now.
Model score 22% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 19% of the time (90 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 2020-03-31, after 2010-03-31 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 2020-03-31. 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: hearthypertensionevidencecelllung
Phrases that lowered it: safetyefficacyopen labelinvestigatorweek -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 37.5% (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: 98.9% (raises risk) · Drug's FDA history
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Primary purpose: treatment (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
- 1 (typical: 0)
- Keywords listed
- 9 (typical: 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
- academic or other
- Sponsor's past trials
- 12 (typical: 32)
- Sponsor's past termination rate
- 16.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 17 (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
- 1708 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 934 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 37.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- ambrisentan
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
- Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH) NCT00989963 · started 2010 · scored riskier than 82% of active trials completed
- Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAH NCT03556020 · started 2018 · scored riskier than 67% of active trials terminated
- Beraprost-314d Added-on to Tyvaso® (BEAT) NCT01908699 · started 2013 · scored riskier than 90% of active trials completed
- Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension NCT02279160 · started 2014 · scored riskier than 92% of active trials completed
- Efficacy and Safety of Ambrisentan in Children 8-18yrs NCT01332331 · started 2011 · scored riskier than 56% 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.