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NCT01724177 · OUTCOME

Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC

A Phase 2 Study of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma · Source last updated 2018-05-29

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

Measure
MEDIAN
Unit
weeks
Interval / dispersion
95% Confidence Interval
Time frame
From day 1 of study treatment to the date of disease progression; up to data cut date of date of 19 May 2017; maximum study duration was 134.1 weeks

What was measured

PFS was defined as the time from the first dose of study treatment to progressive disease (PD) or death due to any cause on study or within 28 days after study discontinuation, whichever occurred earlier.

Analysis population: The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide

Groups in this outcome

Lenalidomide

Lenalidomide 25 mg administered orally once daily (QD) until progressive disease 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
Lenalidomide26

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide16.30Not reported8.10024.000Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.100
        upper Limit
        24.000
        value
        16.30
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
PFS was defined as the time from the first dose of study treatment to progressive disease (PD) or death due to any cause on study or within 28 days after study discontinuation, whichever occurred earlier.
dispersion Type
95% Confidence Interval
groups
  1. description
    Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
    id
    OG000
    title
    Lenalidomide
param Type
MEDIAN
population Description
The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide
reporting Status
POSTED
time Frame
From day 1 of study treatment to the date of disease progression; up to data cut date of date of 19 May 2017; maximum study duration was 134.1 weeks
title
Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Independent clinical review pending · Not medical advice