The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Model scores of the 29,894 trials active now.
Model score 5% 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 6% 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 2012-08-31, after 2011-10-31 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 2012-08-31. 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: patientplacebomay applyprotocol definedcriteria may
Phrases that lowered it: copdchronic obstructiveobstructive pulmonarymoderatepulmonary disease -
Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 13.8% (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports marked serious: 52.8% (lowers risk) · Drug's FDA history
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Minimum age: 40 (lowers risk) · Who can join
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Drug's FAERS reports with a death: 8.2% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor's past trials: 327 (lowers risk) · Sponsor's track record
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Number of arms: 3 (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 61042 (lowers risk) · Drug's FDA history
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Disease area, respiratory: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 278 (raises risk) · Sponsor's track record
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Drugs with FDA adverse-event history: 4 (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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 40 (typical: 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
- 327 (typical: 32)
- Sponsor's past termination rate
- 13.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 278 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 61042 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 11677 (typical: 412.5)
- Drug's FAERS reports marked serious
- 52.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory
- Drugs matched to FDA substances
- albuterol, glycopyrronium, indacaterol, tiotropium
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
- The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD) NCT01574651 · started 2012 · scored riskier than 5% of active trials completed
- A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) NCT01202188 · started 2010 · scored riskier than 4% of active trials completed
- A Study to Assess the Long-term Safety of QVA149 NCT01120717 · started 2010 · scored riskier than 7% of active trials completed
- Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation NCT01610037 · started 2012 · scored riskier than 8% of active trials completed
- Randomized, Double-blind, Placebo-controlled, Multicenter, Cross-over Study to Assess the Effects of a 3 Week Therapy Each With QVA149 Versus Placebo on Pulmonary Function and Average Physical Activity Levels in Patients With COPD. NCT01996319 · started 2014 · scored riskier than 6% 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.