The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants

NCT04113668 on ClinicalTrials.gov Phase 1 Bristol-Myers Squibb (industry) Started 2019-10-01 Completed

Riskier than 1% of active trials

Model scores of the 29,894 trials active now.

Model score 3% 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 in 2015 or later: the model never saw it during training.

How it ended

Completed on 2019-11-25, after 2019-10-01 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 2019-11-25. 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: bmsdiseaseriskstudy treatmentwomen
Phrases that lowered it: healthysinglecrossovervolunteersparticipant
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Phase: 1 (lowers risk) · Design
Sponsor's past termination rate: 10.4% (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 59.6% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 102 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 9.1% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Primary purpose: diagnostic (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Blinding: none (lowers risk) · Design
Maximum age: 50 (lowers risk) · Who can join
Sponsor's past trials: 674 (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Disease area, neurology: 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: non randomized (typical: randomized)
Design: crossover (typical: parallel)
Primary purpose: diagnostic (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: 50 (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: 674 (typical: 32)
Sponsor's past termination rate: 10.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 102 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 569 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 72 (typical: 412.5)
Drug's FAERS reports marked serious: 59.6% (typical: 85.6%)
Drug's FAERS reports with a death: 9.1% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: deucravacitinib, diflunisal

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

A Study of Experimental Medication BMS-986235 in Healthy Subjects NCT03335553 · started 2017 · scored riskier than 7% of active trials completed
An Investigational Study to Evaluate Experimental Medication BMS-986165 Given as a Tablet and Solution in Healthy Male Participants NCT03739788 · started 2018 · scored riskier than 3% of active trials completed
A Study to Compare the Taste and Levels in Blood Plasma of BMS-986165 When Taken as Different Formulations by Healthy Adult Participants NCT04305899 · started 2020 · scored riskier than 1% of active trials completed
A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants NCT04536961 · started 2020 · scored riskier than 0% of active trials completed
A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants NCT05932277 · started 2023 · 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.