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NCT03046953 · OUTCOME

Best Overall Response Rate During the First 8 Cycles of Treatment

Avelumab in Relapsed and Refractory Peripheral T-cell Lymphoma · Source last updated 2024-07-16

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
8 cycles (224 days)

What was measured

Best overall response rate (Completed response \[CR\] + partial remission \[PR\]) during the first 8 cycles of treatment will be assessed using contrast-enhanced CT scans of the neck, chest, abdomen and pelvis, using the Revised Response Criteria for Malignant Lymphoma. In this study CR = complete disappearance of all detectable clinical evidence of disease, so involved lymph nodes had regressed on CT scan to normal size. PR = al least a 50% decrease in size of the involved lymph nodes measured on CT scans.

Analysis population: The per-protocol population was used ,defined as all patients recruited to the trial who started treatment

Groups in this outcome

Avelumab

Avelumab 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days. Avelumab: anti-PDL1 antibody

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

Analysis denominator · Participants

GroupSource count
Avelumab32

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab5Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
description
Best overall response rate (Completed response \[CR\] + partial remission \[PR\]) during the first 8 cycles of treatment will be assessed using contrast-enhanced CT scans of the neck, chest, abdomen and pelvis, using the Revised Response Criteria for Malignant Lymphoma. In this study CR = complete disappearance of all detectable clinical evidence of disease, so involved lymph nodes had regressed on CT scan to normal size. PR = al least a 50% decrease in size of the involved lymph nodes measured on CT scans.
groups
  1. description
    Avelumab 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days. Avelumab: anti-PDL1 antibody
    id
    OG000
    title
    Avelumab
param Type
COUNT_OF_PARTICIPANTS
population Description
The per-protocol population was used ,defined as all patients recruited to the trial who started treatment
reporting Status
POSTED
time Frame
8 cycles (224 days)
title
Best Overall Response Rate During the First 8 Cycles of Treatment
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice