A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Dose-Response Relationship of Multiple Doses of GSK2269557 Administered as a Dry Powder to Chronic Obstructive Pulmonary Disease (COPD) Patients
Model scores of the 29,894 trials active now.
Model score 8% 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 2015-08-18, after 2014-07-31 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 2015-08-18. 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: subject hassubject issafety tolerabilitymultiplethe subject
Phrases that lowered it: copdeffect ofevaluate theto evaluatefev1 -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 5.6% (lowers risk) · Sponsor's track record
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Maximum age: 75 (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Design: parallel (raises risk) · Design
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Minimum age: 40 (lowers risk) · Who can join
-
Sponsor's past trials: 1981 (raises risk) · Sponsor's track record
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Number of arms: 9 (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Keywords listed: 6 (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 314 (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Blinding: double (raises risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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
- 9 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 40 (typical: 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
- 1981 (typical: 32)
- Sponsor's past termination rate
- 5.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 314 (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
- An Efficacy Study of GSK2269557 Added to Standard Care in Subjects With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease NCT02294734 · started 2015 · scored riskier than 8% of active trials completed
- A Study to Assess the Safety and Tolerability of Once Daily Inhaled Doses of GSK573719 Made With Magnesium Stearate in Subjects With Chronic Obstructive Pulmonary Disease(COPD)for 7 Days NCT00732472 · started 2008 · scored riskier than 10% of active trials completed
- Assessment of Lung Function After Single Inhalations of a Bronchodilator From 2 Configurations a Dry Powder Inhaler. NCT01521390 · started 2011 · scored riskier than 1% of active trials completed
- A Study to Evaluate the Safety, Efficacy and Changes in Induced Sputum and Blood Biomarkers Following Daily Repeat Doses of Inhaled GSK2269557 in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Acute Exacerbation NCT02522299 · started 2015 · scored riskier than 10% of active trials completed
- A Non-inferiority Study to Evaluate the Efficacy, Safety, and Tolerability of Fluticasone Propionate/Salmeterol (FSC) 250/50 Microgram (mcg) Through a Capsule-Based Inhaler and a Multi-Dose Inhaler Administered Twice Daily (BID) in Adults With Chronic Obstructive Pulmonary Disease (COPD) NCT01978145 · started 2013 · scored riskier than 4% 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.