Does Low Dose Oral Vitamin K Improve International Normalized Ratio (INR) Stability?
Model scores of the 29,894 trials active now.
Model score 22% for any early termination, 14% 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 (381 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 2014-04-30, after 2010-07-31 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 2014-04-30. 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) (raises risk) · Wording
Phrases that raised it: screeningdouble blindrandomizeddeterminepatient
Phrases that lowered it: inrwarfarinbleedingtherapeuticliver -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 14.3% (raises risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 27.0% (raises risk) · Drug's FDA history
-
Blinding: quadruple (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Collaborators: 2 (lowers risk) · Design
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports marked serious: 92.3% (raises risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
-
Responsible party: principal investigator (lowers risk) · Design
-
Sponsor's past trials: 7 (lowers risk) · Sponsor's track record
-
Number of arms: 2 (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 9 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 7 (typical: 32)
- Sponsor's past termination rate
- 14.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- 678 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 87 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, hematology
- Drugs matched to FDA substances
- phytonadione
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
- Evaluation of Maintenance Dosing vs Loading Dosing Upon Restarting Warfarin Therapy: A Prospective Randomized Trial NCT01124058 · started 2010 · scored riskier than 44% of active trials completed
- Switching Study From Warfarin to Rivaroxaban NCT01507051 · started 2008 · scored riskier than 3% of active trials completed
- Assessment of 2012 Bioequivalence Standards for Warfarin NCT02574754 · started 2016 · scored riskier than 4% of active trials completed
- Study of Evacetrapib (LY2484595) and Warfarin in Healthy Participants NCT02161731 · started 2014 · scored riskier than 3% of active trials completed
- Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation NCT05205863 · started 2021 · 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.