First Time in Human (FTIH) Study to Evaluate Safety, Tolerability, Immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3511294 Administered Subcutaneously (SC) in Subjects With Mild to Moderate Asthma
Model scores of the 29,894 trials active now.
Model score 9% 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 (355 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2019-07-31, after 2017-10-17 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 2019-07-31. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: safety tolerabilitypharmacodynamicsascendingcellssubject
Phrases that lowered it: asthmascreeningparticipantsvaccineblood -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Sponsor's past trials: 2433 (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 60.4% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Sponsor's past termination rate: 6.2% (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 7.2% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Blinding: double (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: 65 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports before start: 131103 (lowers risk) · Drug's FDA history
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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: 223 (raises risk) · Sponsor's track record
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
- 10 (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
- 18
- Maximum age
- 65 (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
- 2433 (typical: 32)
- Sponsor's past termination rate
- 6.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 223 (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
- 131103 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 26375 (typical: 412.5)
- Drug's FAERS reports marked serious
- 60.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory, immunology
- Drugs matched to FDA substances
- albuterol
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 GSK3772847 in Subjects With Moderately Severe Asthma NCT03207243 · started 2017 · scored riskier than 14% of active trials completed
- GSK2190915 Moderate to Severe Asthma Study NCT00850642 · started 2009 · scored riskier than 7% of active trials terminated
- Study to Evaluate GSK2190915 in Subjects With Mild Asthma NCT00812773 · started 2008 · scored riskier than 4% of active trials completed
- Single Dose Study of GSK1440115 in Patients With Asthma NCT01424280 · started 2011 · scored riskier than 4% of active trials completed
- A Study to Evaluate the Effect of Repeat Doses of GW870086X in Mild to Moderate Asthmatics NCT00945932 · started 2009 · scored riskier than 3% 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.