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NCT00784927 · OUTCOME

Progression-free Survival Time

Lenalidomide, Rituximab, Cyclophosphamide, and Dexamethasone in Treating Patients With Previously Untreated Low-Grade Non-Hodgkin Lymphoma · Source last updated 2016-10-07

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 1 year from registration.

What was measured

Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. Progressive disease is defined as having one of the following: * The appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size. * At least a 50% increase from nadir in the sum of the product of the dimension (SPD) of any previously involved nodes. * At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis.

Groups in this outcome

Treatment

Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles: 375 mg/m\^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m\^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22.

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

Analysis denominator · Participants

GroupSource count
Treatment33

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment38.3Not reported25.2NAThe 95% upper confidence limit was not reached.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The 95% upper confidence limit was not reached.
        group Id
        OG000
        lower Limit
        25.2
        upper Limit
        NA
        value
        38.3
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. Progressive disease is defined as having one of the following: * The appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size. * At least a 50% increase from nadir in the sum of the product of the dimension (SPD) of any previously involved nodes. * At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles: 375 mg/m\^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m\^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22.
    id
    OG000
    title
    Treatment
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 1 year from registration.
title
Progression-free Survival Time
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice