Single Dose Study Of The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Health Volunteers
Model scores of the 29,894 trials active now.
Model score 4% 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 2011-07-31, after 2011-07-31 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 2011-07-31. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: pftolerabilitythe pastevidenceprimary
Phrases that lowered it: single dosethe pharmacokineticskgcrossoveropen label -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
-
Sponsor's past termination rate: 16.0% (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 367 (raises risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Drug's FAERS reports with a death: 24.0% (raises risk) · Drug's FDA history
-
Sponsor's past trials: 974 (raises risk) · Sponsor's track record
-
Maximum age: 55 (lowers risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Disease area, neurology: No (lowers risk) · Disease area
-
Primary purpose: basic science (lowers risk) · Design
-
Blinding: none (lowers risk) · Design
-
Disease area, psychiatry: 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
- 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
- 974 (typical: 32)
- Sponsor's past termination rate
- 16.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 367 (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
- 18015 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3991 (typical: 412.5)
- Drug's FAERS reports marked serious
- 86.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- cyclosporine
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
- Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy Volunteers NCT01351129 · started 2011 · scored riskier than 2% of active trials completed
- Study To Assess The Pharmacokinetics Of 2 Different Formulations Of PF-04991532 NCT01388829 · started 2011 · scored riskier than 1% of active trials completed
- A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult Volunteers NCT01091272 · started 2010 · scored riskier than 8% of active trials completed
- Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy Volunteers NCT02228395 · started 2014 · scored riskier than 9% of active trials completed
- Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers NCT01238679 · started 2010 · scored riskier than 8% of active trials terminated
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.