A Clinical Study of Ruxolitinib in Patients With Primary Myelofibrosis (PM), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis

NCT02087059 on ClinicalTrials.gov Phase 3 Novartis Pharmaceuticals (industry) Started 2014-04-30 Completed

Riskier than 35% of active trials

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (139 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 2015-04-30, after 2014-04-30 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 2015-04-30. 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: cellcarcinomarisksquamouspatient
Phrases that lowered it: days beforedrugopen labelsafety ofaccording
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Drug's FAERS reports marked serious: 54.4% (lowers risk) · Drug's FDA history
Sponsor's past termination rate: 11.8% (raises risk) · Sponsor's track record
Design: single group (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports with a death: 20.3% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 296 (raises risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Responsible party: sponsor (lowers 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: 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: 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: industry (typical: academic or other)
Sponsor's past trials: 636 (typical: 32)
Sponsor's past termination rate: 11.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 296 (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: 2839 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2189 (typical: 412.5)
Drug's FAERS reports marked serious: 54.4% (typical: 85.6%)
Drug's FAERS reports with a death: 20.3% (typical: 15.9%)

Disease area and drugs

Disease areas: hematology
Drugs matched to FDA substances: ruxolitinib

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

Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients. NCT02966353 · started 2017 · scored riskier than 79% of active trials completed
Trial Ruxolitinib and Peg-interferon Alpha-2a Combination in Patients With Primary Myelofibrosis RUXOPeg NCT02742324 · started 2016 · scored riskier than 76% of active trials completed
Ruxolitinib and Pomalidomide Combination Therapy in Patients With Primary and Secondary MF NCT01644110 · started 2013 · scored riskier than 80% of active trials completed
INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis. NCT01493414 · started 2011 · scored riskier than 69% of active trials completed
Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis NCT01969838 · started 2013 · scored riskier than 94% 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.