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NCT01724177 · OUTCOME

Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response (CRu), Partial Response or Stable Disease (SD) 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
percentage of participants
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 tumor control rate was measured for those with a response of Complete Remission, + CRu, + PR + Stable Disease (SD) in the EE population based on the best response.

Analysis population: The EE population with a response (CR, CRu, PR or SD) and 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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide73.1Not reported52.21388.427Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        52.213
        upper Limit
        88.427
        value
        73.1
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
The tumor control rate was measured for those with a response of Complete Remission, + CRu, + PR + Stable Disease (SD) in the EE population based on the best response.
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
NUMBER
population Description
The EE population with a response (CR, CRu, PR or SD) and 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 first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks
title
Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response (CRu), Partial Response or Stable Disease (SD) as Assessed by the ESEC
type
SECONDARY
unit Of Measure
percentage of participants

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

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