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NCT03075553 · OUTCOME

Response Rate for Participants Who Achieve a CR or PR [CT-based Response]

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 390 days

What was measured

The response rate for participants who achieve a CR or PR is defined as the percentage of participants who achieve a CR or PR assessed according to the revised Lugano Classification Response criteria. Complete response (CR): target nodes/nodal masses must regress to \<=1.5 cm in longest transverse diameter (LDi). Partial response (PR): \>= 50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites.

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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Nivolumab)33.3Not reported12.363.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.3
        upper Limit
        63.7
        value
        33.3
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
The response rate for participants who achieve a CR or PR is defined as the percentage of participants who achieve a CR or PR assessed according to the revised Lugano Classification Response criteria. Complete response (CR): target nodes/nodal masses must regress to \<=1.5 cm in longest transverse diameter (LDi). Partial response (PR): \>= 50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites.
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
NUMBER
reporting Status
POSTED
time Frame
Up to 390 days
title
Response Rate for Participants Who Achieve a CR or PR [CT-based Response]
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice