A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD

NCT03573817 on ClinicalTrials.gov Phase 3 Mylan Inc. (industry) Started 2018-05-31 Completed

Riskier than 4% of active trials

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 6% of the time (528 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2018-09-25, after 2018-05-31 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 2018-09-25. 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: chronicdiseasepulmonaryconcurrentfunction
Phrases that lowered it: participantsolutionsafetysmokingmale
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 3.8% (lowers risk) · Sponsor's track record
Minimum age: 40 (lowers risk) · Who can join
Phase: 3 (lowers risk) · Design
Drug's FAERS reports marked serious: 53.5% (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 6.2% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Design: parallel (raises risk) · Design
Number of arms: 4 (lowers risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area
Blinding: quadruple (lowers risk) · Design
Maximum age: not given (lowers risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
Sponsor's past trials: 26 (lowers risk) · Sponsor's track record
Collaborators: 1 (raises 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: 3 (typical: 2)
Number of arms: 4 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 40 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 26 (typical: 32)
Sponsor's past termination rate: 3.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 3 (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: 57003 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 9155 (typical: 412.5)
Drug's FAERS reports marked serious: 53.5% (typical: 85.6%)
Drug's FAERS reports with a death: 6.2% (typical: 15.9%)

Disease area and drugs

Disease areas: respiratory
Drugs matched to FDA substances: formoterol, revefenacin

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

Revefenacin in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease(COPD) NCT05046795 · started 2021 · scored riskier than 6% of active trials completed
Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD NCT03095456 · started 2017 · scored riskier than 7% of active trials completed
Flutiform® Compared With Seretide® in the Treatment of COPD NCT02195375 · started 2014 · scored riskier than 12% of active trials completed
Formoterol Dose Ranging Study (ACHIEVE Duaklir USA Phase IIb) NCT02796651 · started 2016 · scored riskier than 3% of active trials completed
QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) NCT01315249 · started 2011 · scored riskier than 4% 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.