A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 1% 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
Completed on 2009-12-31, after 2008-02-29 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 2009-12-31. 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) (lowers risk) · Wording
Phrases that raised it: subjectsstageplacebo controlledblind placeboii
Phrases that lowered it: copdmoderateevaluateand safetyefficacy and -
Sponsor's past termination rate: 14.7% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Phase: 2 (raises risk) · Design
-
Minimum age: 40 (lowers risk) · Who can join
-
Design: parallel (raises risk) · Design
-
Responsible party: not given (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 246 (raises 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 marked serious: no FAERS history (raises risk) · Drug's FDA history
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Maximum age: 80 (raises risk) · Who can join
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Sponsor's past trials: 360 (raises risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
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Blinding: double (raises risk) · Design
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Keywords listed: 0 (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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 40 (typical: 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
- 360 (typical: 32)
- Sponsor's past termination rate
- 14.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 246 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory
- Drugs matched to FDA substances
- none matched
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
- Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) Taking Salmeterol Xinafoate/Fluticasone Propionate Combination NCT01321463 · started 2011 · scored riskier than 36% of active trials completed
- An Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary Disease NCT02366637 · started 2015 · scored riskier than 13% of active trials terminated
- A Phase 2a Study to Assess Safety, Daily Symptoms, PK, and Biomarkers of YPL-001 in COPD Patients NCT02272634 · started 2015 · scored riskier than 24% of active trials completed
- Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Tiotropium Bromide NCT01543919 · started 2012 · scored riskier than 77% of active trials completed
- A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease NCT01033487 · started 2010 · scored riskier than 14% 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.