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NCT01776723 · OUTCOME

Percentage of Participants With Acute Myeloid Leukemia (AML) Transformation

A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib · Source last updated 2022-09-22

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
Up to 2 years

What was measured

Phase II - To determine the time to AML transformation of participants on Ruxolitinib. Acute myeloid leukemia (AML) transformation according to World Health Organization (WHO) criteria. CMML-1: peripheral blood \<5% blasts, bone marrow \<10% myeloblast. CMML-2: peripheral blood \<19 percent blasts persistent monocytosis \>1000/ul +/- cytopenias Leukocytosis frequent, bone marrow \<19 percent blasts \>10% dysplasia in affected lineage, Auer Rods.

Groups in this outcome

All Participants

All participants who received at least one dose of Ruxuxolitinib

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

Analysis denominator · Participants

GroupSource count
All Participants30

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants14Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Phase II - To determine the time to AML transformation of participants on Ruxolitinib. Acute myeloid leukemia (AML) transformation according to World Health Organization (WHO) criteria. CMML-1: peripheral blood \<5% blasts, bone marrow \<10% myeloblast. CMML-2: peripheral blood \<19 percent blasts persistent monocytosis \>1000/ul +/- cytopenias Leukocytosis frequent, bone marrow \<19 percent blasts \>10% dysplasia in affected lineage, Auer Rods.
groups
  1. description
    All participants who received at least one dose of Ruxuxolitinib
    id
    OG000
    title
    All Participants
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 2 years
title
Percentage of Participants With Acute Myeloid Leukemia (AML) Transformation
type
SECONDARY
unit Of Measure
percentage of patients

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice