Single Dose of pGM169/GL67A in CF Patients
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (40 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 2010-12-31, after 2008-11-30 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 2010-12-31. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: hoursrenalliverintravenoussafety tolerability
Phrases that lowered it: fev1single doselungobjectivesparticipation in -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Collaborators: 5 (lowers risk) · Design
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Phase: 1/2 (raises risk) · Design
-
Sponsor's past termination rate: 5.3% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Number of arms: 3 (lowers risk) · Design
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Maximum age: 70 (lowers risk) · Who can join
-
Blinding: none (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 15 (lowers 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
- 1/2 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 5 (typical: 0)
- Keywords listed
- 8 (typical: 1)
Who can join
- Minimum age
- 16 (typical: 18)
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 38 (typical: 32)
- Sponsor's past termination rate
- 5.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 15 (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, digestive
- 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
- Repeated Application of Gene Therapy in CF Patients NCT01621867 · started 2012 · scored riskier than 28% of active trials completed
- Study of GLPG1837 in Subjects With Cystic Fibrosis (G551D Mutation) NCT02707562 · started 2016 · scored riskier than 26% of active trials completed
- Study of GLPG1837 in Subjects With Cystic Fibrosis (S1251N Mutation) NCT02690519 · started 2016 · scored riskier than 19% of active trials completed
- Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis NCT03450720 · started 2017 · scored riskier than 8% of active trials completed
- Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin NCT00634192 · started 2008 · scored riskier than 2% 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.