A Relative Bioavailability Study To Evaluate Safety, Tolerability And Pharmacokinetic Comparability Of Pegvisomant 1 X 30 Mg Vs 2 X 15 Mg Subcutaneously Administered In Healthy Subjects
Model scores of the 29,894 trials active now.
Model score 5% 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 5% of the time (4,470 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 2013-10-31, after 2013-08-31 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 2013-10-31. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjectssafety tolerabilityeffective28 daysmethods
Phrases that lowered it: healthymgml ofbioavailabilitypharmacokinetic -
Sponsor's past termination rate: 15.9% (raises risk) · Sponsor's track record
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Design: crossover (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Sponsor's past trials: 1280 (raises risk) · Sponsor's track record
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Primary purpose: basic science (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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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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Drug's FAERS reports with a death: 11.5% (lowers risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Blinding: none (lowers risk) · Design
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
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- 1280 (typical: 32)
- Sponsor's past termination rate
- 15.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 231 (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
- 104 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 24 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- pegvisomant
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
- Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers NCT02725112 · started 2016 · scored riskier than 2% of active trials completed
- A Study of the Safety and Tolerability of GWP42006 in Healthy Subjects NCT01918735 · started 2013 · scored riskier than 4% of active trials completed
- A Study To Evaluate the Safety, Tolerability, And Pharmacokinetics Of PF-06266047 In Healthy Adult Subjects NCT02539550 · started 2015 · scored riskier than 6% of active trials completed
- Single Dose Safety Study for Compound to Treat Post-Operative Nausea and Vomiting (PONV) NCT01290133 · started 2011 · scored riskier than 4% of active trials completed
- A Multiple Dose Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04457845 in Healthy Volunteers NCT00836082 · started 2009 · scored riskier than 5% 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.