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NCT03075553 · OUTCOME

Progression-Free Survival (PFS)

Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma · Source last updated 2020-04-21

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
The time from registration to relapse or death due to any cause, an average of 2 years

What was measured

The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. In addition, the progression-free survival rate will be reported. progressive disease (PD): a Lugano score of 4 to 5 with increasing intensity compared to baseline or any interim scan and/or any new FDG-avid focus consistent with malignant lymphoma.The Lugano 5-PS is a scale used for initial staging and assessment of treatment response in Hodgkin lymphoma (HL) and certain types of non-Hodgkin lymphomas (NHL). The scale ranges from 1 to 5, where 1 is best and 5 is the worst. Each FDG-avid (or previously FDG-avid) lesion is rated independently: 1. no uptake or no residual uptake 2. slight uptake, but equal to or below blood pool 3. uptake above mediastinal, but below or equal to uptake in the liver 4. uptake slightly to moderately higher than liver 5. markedly increased uptake or any new lesion (on response evaluation)

Groups in this outcome

Treatment (Nivolumab)

Patients receive 240 mg nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive 480 mg nivolumab IV over 60 minutes on day 1 of cycle 9. Treatment repeats every 28 days for up to 24 cycles in the absence of 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
Treatment (Nivolumab)12

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Nivolumab)1.9Not reported1.58.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.5
        upper Limit
        8.7
        value
        1.9
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. In addition, the progression-free survival rate will be reported. progressive disease (PD): a Lugano score of 4 to 5 with increasing intensity compared to baseline or any interim scan and/or any new FDG-avid focus consistent with malignant lymphoma.The Lugano 5-PS is a scale used for initial staging and assessment of treatment response in Hodgkin lymphoma (HL) and certain types of non-Hodgkin lymphomas (NHL). The scale ranges from 1 to 5, where 1 is best and 5 is the worst. Each FDG-avid (or previously FDG-avid) lesion is rated independently: 1. no uptake or no residual uptake 2. slight uptake, but equal to or below blood pool 3. uptake above mediastinal, but below or equal to uptake in the liver 4. uptake slightly to moderately higher than liver 5. markedly increased uptake or any new lesion (on response evaluation)
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive 240 mg nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive 480 mg nivolumab IV over 60 minutes on day 1 of cycle 9. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Treatment (Nivolumab)
param Type
MEDIAN
reporting Status
POSTED
time Frame
The time from registration to relapse or death due to any cause, an average of 2 years
title
Progression-Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice