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NCT01724177 · OUTCOME

Kaplan-Meier Estimate of Duration of Response (DOR) for Responders 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
NUMBER
Unit
weeks
Interval / dispersion
95% Confidence Interval
Time frame
From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; Maximum study duration was 134.1 Weeks

What was measured

The response duration in participants with an objective response was measured from the date of the first Complete Response or Complete Response unconfirmed or Partial Response to the first date of Relapsed Disease or Progressive Disease (PD). For participants who did not progress during the study, DOR was censored at the last adequate response assessment not showing evidence of PD.

Analysis population: The EE population who had a documented response and consisted of 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 by mouth (PO) 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
Lenalidomide11

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide24.10Not reported2.000NAOnly one event data observed exceeding the median value, and maximum value was censored data, so the upper bound of confidence interval (CI) could not be estimated
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Only one event data observed exceeding the median value, and maximum value was censored data, so the upper bound of confidence interval (CI) could not be estimated
        group Id
        OG000
        lower Limit
        2.000
        upper Limit
        NA
        value
        24.10
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
The response duration in participants with an objective response was measured from the date of the first Complete Response or Complete Response unconfirmed or Partial Response to the first date of Relapsed Disease or Progressive Disease (PD). For participants who did not progress during the study, DOR was censored at the last adequate response assessment not showing evidence of PD.
dispersion Type
95% Confidence Interval
groups
  1. description
    Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
    id
    OG000
    title
    Lenalidomide
param Type
NUMBER
population Description
The EE population who had a documented response and consisted of 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 first documented response; up to data cut-off date of 19 May 2017; Maximum study duration was 134.1 Weeks
title
Kaplan-Meier Estimate of Duration of Response (DOR) for Responders 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