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NCT02201329 · OUTCOME

Overall Objective Response (OR): Complete Remission (CR), Partial Remission (PR), or Marrow CR (mCR)

Volasertib in Combination With Azacitidine in Japanese Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia · Source last updated 2018-07-30

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 9 months.

What was measured

This outcome measure presents overall Objective Response (CR+PR+mCR). Response to treatment was evaluated according to the International Working Group (IWG) 2006 criteria. Best response was tabulated from all available data, with each patient being classified into one of the categories defined in CR, PR, mCR.

Analysis population: Treated Set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of either Volasertib or Azacitidine.

Groups in this outcome

Volasertib 200 mg

The patients received Volasertib 200 mg administered by Intravenous Infusion (IV) over 60 minutes on Day 1 and Day 15 of 28-day and Azacitidine 75 mg/m\^2 administered by subcutaneous injection on days 1-7 of 28 day treatment cycle.

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

Analysis denominator · Participants

GroupSource count
Volasertib 200 mg5

Reported measurements

Objective Response (OR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Volasertib 200 mg2Not reportedNot reportedNot reportedNot reported
Complete Remission (CR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Volasertib 200 mg0Not reportedNot reportedNot reportedNot reported
Partial Remission (PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Volasertib 200 mg0Not reportedNot reportedNot reportedNot reported
Marrow Complete Remission (mCR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Volasertib 200 mg2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Objective Response (OR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete Remission (CR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Partial Remission (PR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Marrow Complete Remission (mCR)
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
This outcome measure presents overall Objective Response (CR+PR+mCR). Response to treatment was evaluated according to the International Working Group (IWG) 2006 criteria. Best response was tabulated from all available data, with each patient being classified into one of the categories defined in CR, PR, mCR.
groups
  1. description
    The patients received Volasertib 200 mg administered by Intravenous Infusion (IV) over 60 minutes on Day 1 and Day 15 of 28-day and Azacitidine 75 mg/m\^2 administered by subcutaneous injection on days 1-7 of 28 day treatment cycle.
    id
    OG000
    title
    Volasertib 200 mg
param Type
NUMBER
population Description
Treated Set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of either Volasertib or Azacitidine.
reporting Status
POSTED
time Frame
Up to 9 months.
title
Overall Objective Response (OR): Complete Remission (CR), Partial Remission (PR), or Marrow CR (mCR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice