Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
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 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 2011-10-06, after 2010-06-28 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 2011-10-06. 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: placebodiseaseconcurrentreceptormonths
Phrases that lowered it: asthmaonce dailyto evaluateevaluate thesubjects -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 4.4% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports with a death: 5.4% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 61.1% (lowers risk) · Drug's FDA history
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Blinding: quadruple (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 438 (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Sponsor's past trials: 1193 (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 7 (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (lowers risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 5595 (lowers risk) · Drug's FDA history
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Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
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Minimum age: 12 (lowers risk) · Who can join
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
- 7 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 10 (typical: 1)
Who can join
- Minimum age
- 12 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1193 (typical: 32)
- Sponsor's past termination rate
- 4.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 438 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 29182 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5595 (typical: 412.5)
- Drug's FAERS reports marked serious
- 61.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory, immunology
- Drugs matched to FDA substances
- fluticasone, fluticasone propionate, montelukast
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
- Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age NCT01156792 · started 2010 · scored riskier than 5% of active trials completed
- Safety and Efficacy Study Adding GSK2190915 to Mid-dose Inhaled Corticosteroid/Long Acting Beta Agonist Combination Treatment for Asthma NCT01248975 · started 2010 · scored riskier than 6% of active trials completed
- A 3-period Crossover Study With GSK573719 as Monotherapy in Adult Subjects With Asthma NCT01641692 · started 2012 · scored riskier than 4% of active trials completed
- Evaluate the Safety, Efficacy and Dose Response of GSK573719 in Combination With Fluticasone Furoate in Subjects With Asthma NCT01573624 · started 2012 · scored riskier than 6% of active trials completed
- Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma NCT00843193 · started 2008 · scored riskier than 8% 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.