A Phase 2 Study to Determine the Safety and Efficacy of AIR001 in Subjects With Pulmonary Arterial Hypertension (PAH)
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% 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 2014-02-28, after 2012-11-30 start.
Reason given by the sponsor: “business”
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 2014-02-28. 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: mmhgpahdiseaselungleft
Phrases that lowered it: evaluateeffect ofthe effectdaysdose -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Phase: 2 (raises risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports marked serious: 65.3% (lowers risk) · Drug's FDA history
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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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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Blinding: none (raises risk) · Design
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Drug's FAERS reports with a death: 14.3% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past trials: 2 (raises risk) · Sponsor's track record
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Collaborators: 0 (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Keywords listed: 5 (lowers 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
- 2
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (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
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 49 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 9 (typical: 412.5)
- Drug's FAERS reports marked serious
- 65.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory
- Drugs matched to FDA substances
- nitrite
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
- Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy NCT01560624 · started 2012 · scored riskier than 94% of active trials completed
- A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH) NCT03496207 · started 2018 · scored riskier than 71% of active trials completed
- Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA) NCT05934526 · started 2023 · scored riskier than 66% of active trials completed
- Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH NCT02725372 · started 2016 · scored riskier than 97% of active trials terminated
- Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension. NCT01884675 · started 2013 · scored riskier than 67% 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.