PROphylaxis in NOn Major Orthopaedic Surgery

NCT02401594 on ClinicalTrials.gov Phase 3 Centre Hospitalier Universitaire de Saint Etienne (academic or other) Started 2015-12-08 Terminated

Riskier than 32% of active trials

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 12% 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 in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2018-04-16, after 2015-12-08 start.

Reason given by the sponsor: “business”

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 2018-04-16. 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

Sponsor's past termination rate: 20.3% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: randomizationhoursdouble blindsubjectintended
Phrases that lowered it: bleedingonce dailykneeand safetysurgery
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Blinding: triple (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Trials the sponsor started in the prior 2 years: 40 (lowers risk) · Sponsor's track record
Primary purpose: prevention (lowers risk) · Design
Design: parallel (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 14.1% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports in the prior 12 months: 31393 (raises risk) · Drug's FDA history
Disease area, cardiovascular: Yes (raises risk) · Disease area
Disease area, neurology: No (lowers risk) · Disease area
Sponsor's past trials: 64 (lowers risk) · Sponsor's track record

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: prevention (typical: treatment)
Blinding: triple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 2 (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: 64 (typical: 32)
Sponsor's past termination rate: 20.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 40 (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: 74064 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 31393 (typical: 412.5)
Drug's FAERS reports marked serious: 86.1% (typical: 85.6%)
Drug's FAERS reports with a death: 14.1% (typical: 15.9%)

Disease area and drugs

Disease areas: cardiovascular
Drugs matched to FDA substances: enoxaparin, rivaroxaban

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

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A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery NCT00843492 · started 2008 · scored riskier than 19% of active trials completed
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery NCT00721760 · started 2008 · scored riskier than 22% of active trials completed
Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery NCT00709904 · started 2008 · scored riskier than 20% of active trials completed
Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy NCT01629381 · started 2012 · scored riskier than 66% 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.