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NCT00352001 · OUTCOME

Time to Transformation to Acute Myeloid Leukemia or Death

Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndromes · Source last updated 2018-09-19

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
After 7 months of treatment, until the date of first documented myeloid leukemia or death, whichever came first, assessed up to 55 months

What was measured

Time (in months) patients took to evolve to myeloid leukemia or death after achieving a complete response using the RECIST criteria

Analysis population: Patients who achieved a complete response

Groups in this outcome

Lenalidomide and Azacitidine

azacitidine: Azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity. lenalidomide: Oral lenalidomide once daily on days 1-14 or days 1-21.Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Lenalidomide and Azacitidine16

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Lenalidomide and Azacitidine13.6Not reported355Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        upper Limit
        55
        value
        13.6
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
Time (in months) patients took to evolve to myeloid leukemia or death after achieving a complete response using the RECIST criteria
dispersion Type
Full Range
groups
  1. description
    azacitidine: Azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity. lenalidomide: Oral lenalidomide once daily on days 1-14 or days 1-21.Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.
    id
    OG000
    title
    Lenalidomide and Azacitidine
param Type
MEDIAN
population Description
Patients who achieved a complete response
reporting Status
POSTED
time Frame
After 7 months of treatment, until the date of first documented myeloid leukemia or death, whichever came first, assessed up to 55 months
title
Time to Transformation to Acute Myeloid Leukemia or Death
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice