The Nitrite and Coronary Flow Study
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 17% of the time (106 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-12-01, after 2018-07-01 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 2018-12-01. 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: mrior equalequal togreater thancoronary
Phrases that lowered it: femalemaleagedstudycriteria -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 1/2 (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 59.6% (lowers risk) · Drug's FDA history
-
Design: single group (raises risk) · Design
-
Drug's FAERS reports with a death: 15.1% (lowers risk) · Drug's FDA history
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 6 (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Number of arms: 1 (raises risk) · Design
-
Blinding: none (raises risk) · Design
-
Sponsor's past trials: 17 (lowers risk) · Sponsor's track record
-
Collaborators: 1 (raises risk) · Design
-
Disease area, cardiovascular: Yes (raises 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
- 1/2 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 17 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (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
- 166 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 30 (typical: 412.5)
- Drug's FAERS reports marked serious
- 59.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 15.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- nitrite
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
- Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults NCT01681836 · started 2012 · scored riskier than 1% of active trials completed
- Safety and Effectiveness of Intra-coronary Nitrite in Acute Myocardial Infarction NCT01584453 · started 2012 · scored riskier than 70% of active trials completed
- The Effects of Inorganic Nitrate on Cardiac Muscle in Angina NCT02078921 · started 2012 · scored riskier than 31% of active trials completed
- Sodium Nitrite to Treat Arterial Aging NCT02022670 · started 2011 · scored riskier than 21% of active trials completed
- Phase IIa: Safety, PK, & Tolerability of Sodium Nitrite in Patients With Peripheral Arterial Disease-SONIC NCT01401517 · started 2011 · scored riskier than 63% 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.