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NCT01350947 · OUTCOME

Percentage of Patients With Complete Hematologic Response (According to IWG 2006 Criteria) in CMML Patients Treated With 5-azacitidine.

A Study of 5-Azacitidine (Vidaza®) in Patients With Chronic Myelomonocytic Leukemia · Source last updated 2016-06-13

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
24 months

What was measured

Complete Hematologic Response is defined as: bone marrow evaluation shows \<= 5% myeloblasts with normal maturation of all cells lines; peripheral blood evaluation shows hemoglobin \>= 11 g/dL, neutrophils \>= 1000/mL, platelets \>= 100,000/mL, 0% blasts

Groups in this outcome

Arm 1 - 5-Azacitidine

All participants enrolled. 5-Azacitidine: Administered on Days 1-7 of each Cycle. Subcutaneous administration: To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration. The 5-azacitidine suspension is administered subcutaneously. Intravenous Administration: 5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes.

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

Analysis denominator · Participants

GroupSource count
Arm 1 - 5-Azacitidine11

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - 5-Azacitidine27Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        27
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
Complete Hematologic Response is defined as: bone marrow evaluation shows \<= 5% myeloblasts with normal maturation of all cells lines; peripheral blood evaluation shows hemoglobin \>= 11 g/dL, neutrophils \>= 1000/mL, platelets \>= 100,000/mL, 0% blasts
groups
  1. description
    All participants enrolled. 5-Azacitidine: Administered on Days 1-7 of each Cycle. Subcutaneous administration: To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration. The 5-azacitidine suspension is administered subcutaneously. Intravenous Administration: 5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes.
    id
    OG000
    title
    Arm 1 - 5-Azacitidine
param Type
NUMBER
reporting Status
POSTED
time Frame
24 months
title
Percentage of Patients With Complete Hematologic Response (According to IWG 2006 Criteria) in CMML Patients Treated With 5-azacitidine.
type
PRIMARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice