A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
Model scores of the 29,894 trials active now.
Model score 15% 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 14% of the time (493 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 2014-07-31, after 2010-10-01 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 2014-07-31. 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: subjectchronicpulmonaryscreeningheart
Phrases that lowered it: combinationlinereceivedhumansubjects who -
Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports marked serious: 57.3% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Sponsor's past termination rate: 4.4% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 14.6% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Blinding: quadruple (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 445 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Collaborators: 1 (raises risk) · Design
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Sponsor's past trials: 1254 (raises risk) · Sponsor's track record
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Disease area, respiratory: Yes (raises risk) · Disease area
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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 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
- 1254 (typical: 32)
- Sponsor's past termination rate
- 4.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 445 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 7739 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1979 (typical: 412.5)
- Drug's FAERS reports marked serious
- 57.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, respiratory
- Drugs matched to FDA substances
- ambrisentan, tadalafil
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 Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) NCT03904693 · started 2019 · scored riskier than 54% of active trials completed
- Beraprost-314d Added-on to Tyvaso® (BEAT) NCT01908699 · started 2013 · scored riskier than 90% of active trials completed
- A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH) NCT01824290 · started 2014 · scored riskier than 48% of active trials completed
- Ambrisentan in Patients With Porto-pulmonary Hypertension A Multicenter Open Label Trial NCT01224210 · started 2010 · scored riskier than 79% of active trials completed
- Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil NCT00796666 · started 2009 · scored riskier than 55% 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.