A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin
Model scores of the 29,894 trials active now.
Model score 10% 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 11% of the time (493 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 2011-06-29, after 2010-09-14 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 2011-06-29. 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: strokeheparinchronicdiseasebowel
Phrases that lowered it: atorvastatinhypercholesterolemiasubjects whoinvestigatorcholesterol -
Sponsor's past termination rate: 4.3% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Blinding: triple (raises risk) · Design
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Phase: 2 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 448 (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Sponsor's past trials: 1243 (raises 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: 5.9% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 67.0% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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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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Sponsor type: industry (lowers risk) · Sponsor's track record
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Number of arms: 16 (lowers risk) · Design
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Maximum age: 75 (raises risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 18188 (lowers risk) · Drug's FDA history
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Disease area, metabolic: Yes (lowers 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
- 2
- Number of arms
- 16 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (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
- 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
- 1243 (typical: 32)
- Sponsor's past termination rate
- 4.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 448 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 76408 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 18188 (typical: 412.5)
- Drug's FAERS reports marked serious
- 67.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic
- Drugs matched to FDA substances
- atorvastatin, ezetimibe
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 Test GSK256073 in Patients With Dyslipidemia NCT00903617 · started 2009 · scored riskier than 22% of active trials completed
- A Study to Investigate the Interaction of GSK1292263 With Rosuvastatin and Simvastatin in Healthy Subjects NCT01101568 · started 2010 · scored riskier than 3% of active trials completed
- Drug-drug Interaction Study of GSK1278863 With Pioglitazone, Rosuvastatin and Trimethoprim in Healthy Adult Volunteers NCT02371603 · started 2015 · scored riskier than 1% of active trials completed
- A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184 NCT01953835 · started 2013 · scored riskier than 1% of active trials completed
- A Phase 1 Study to Evaluate the Drug-Drug Interaction Potential Between ALG-055009 and Statin Therapy(Ies) NCT06191991 · started 2023 · 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.