Efficacy and Safety Study of QVA149 in COPD Patients
Model scores of the 29,894 trials active now.
Model score 4% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-09-12, after 2015-07-28 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2016-09-12. 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: lung cancerpatientefficacy ofactiveand tolerability
Phrases that lowered it: copdchronic obstructivepulmonary diseaseobstructive pulmonarybronchodilator -
Design: crossover (lowers risk) · Design
-
Sponsor's past termination rate: 14.4% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Minimum age: 40 (lowers risk) · Who can join
-
Drug's FAERS reports with a death: 12.9% (lowers risk) · Drug's FDA history
-
Sponsor's past trials: 794 (raises 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 type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 70.8% (lowers risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Blinding: double (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 242 (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
- 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
- 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
- 794 (typical: 32)
- Sponsor's past termination rate
- 14.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 242 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 5 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 2532 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1600 (typical: 412.5)
- Drug's FAERS reports marked serious
- 70.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory
- Drugs matched to FDA substances
- glycopyrrolate, glycopyrronium, indacaterol, umeclidinium, vilanterol
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
- Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients. NCT02487498 · started 2015 · scored riskier than 4% of active trials completed
- QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) NCT01315249 · started 2011 · scored riskier than 4% of active trials completed
- A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation. NCT01727141 · started 2012 · scored riskier than 10% of active trials completed
- Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease NCT03162055 · started 2017 · scored riskier than 7% of active trials completed
- A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149 NCT01709903 · started 2012 · 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.