NCT02038036 · OUTCOME

Number of Participants Developing Thrombosis

Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy. · Source last updated 2021-07-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From randomization to Week 80 for BAT and Week 260 for Ruxolitinib

What was measured

Proportion of participants developing any arterial or venous thromboembolic event

Analysis population: Safety Set comprised of all randomized participants who received at least one dose of ruxolitinib or BAT.

Groups in this outcome

Ruxolitinib

Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid

Best Available Therapy (BAT)

Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Ruxolitinib	74
Best Available Therapy (BAT)	75

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0	Not reported	Not reported	Not reported	Not reported
Best Available Therapy (BAT)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0

denoms

counts
group Id
OG000
value
74
group Id
OG001
value
75
units
Participants

description

Proportion of participants developing any arterial or venous thromboembolic event

groups

description
Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid
id
OG000
title
Ruxolitinib
description
Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib
id
OG001
title
Best Available Therapy (BAT)

param Type

COUNT_OF_PARTICIPANTS

population Description

Safety Set comprised of all randomized participants who received at least one dose of ruxolitinib or BAT.

reporting Status

POSTED

time Frame

From randomization to Week 80 for BAT and Week 260 for Ruxolitinib

title

Number of Participants Developing Thrombosis

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice