Single and Repeated Dose Escalation Study of GSK2838232
Model scores of the 29,894 trials active now.
Model score 7% for any early termination, 0% 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 (776 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-12-31, after 2016-03-31 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 2016-12-31. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: safety tolerabilitytolerability andventricularheartescalation
Phrases that lowered it: screeninglabelsinglehealthytablet -
Sponsor's past trials: 2225 (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Blinding: double (raises risk) · Design
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Disease area, urogenital: Yes (raises risk) · Disease area
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Sponsor's past termination rate: 5.9% (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports with a death: 10.4% (lowers risk) · Drug's FDA history
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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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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 232 (raises risk) · Sponsor's track record
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Disease area, neurology: No (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
- 1 (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
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 2225 (typical: 32)
- Sponsor's past termination rate
- 5.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 232 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 23023 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2870 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, immunology, urogenital
- Drugs matched to FDA substances
- ritonavir
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
- A Single Dose Pharmacokinetic (PK) and Safety Study of GSK2838232 With and Without Ritonavir (RTV) Conducted in Healthy Subjects NCT02289482 · started 2014 · scored riskier than 6% of active trials terminated
- A Repeat Dose Pharmacokinetic (PK) and Safety Study of GSK2838232 With and Without Ritonavir (RTV) Conducted in Healthy Subjects NCT02289495 · started 2014 · scored riskier than 6% of active trials terminated
- A Two-part Study to Compare a Tablet and Capsule Formulation of GSK2838232 With and Without Food, and to Assess the Safety and Drug Levels of Repeated Once-daily Doses of GSK2838232 Without Ritonavir NCT03234036 · started 2017 · scored riskier than 5% of active trials completed
- Single Dose Escalation Study of GSK2838232 in Healthy Subjects NCT01802918 · started 2013 · scored riskier than 3% of active trials completed
- Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults NCT03045861 · started 2017 · scored riskier than 16% 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.