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NCT03046953 · OUTCOME

Maximum Percentage Change in Sum of Product of Diameters

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
MEDIAN
Unit
percentage change
Interval / dispersion
Inter-Quartile Range
Time frame
During trial treatment of 8 cycles (224 days), comparing baseline with cycles 3, 6 and 8

What was measured

Maximum percentage change in the sum of the product of diameters (SPD) of target tumour masses assessed by contrast-enhanced CT scans of the neck, chest, abdomen and pelvis, using the Revised Response Criteria for Malignant Lymphoma.

Analysis population: 13 of the 32 patients who started treatment had available CT scans containing the target lesions at cycles 3, 6 or 8 for comparison with baseline, and these patients were included in this analysis

Groups in this outcome

Avelumab

Patients received 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
Avelumab13

Reported measurements

Source class 1
Values in percentage change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Avelumab-4.3Not reported-56.628.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -56.6
        upper Limit
        28.1
        value
        -4.3
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Maximum percentage change in the sum of the product of diameters (SPD) of target tumour masses assessed by contrast-enhanced CT scans of the neck, chest, abdomen and pelvis, using the Revised Response Criteria for Malignant Lymphoma.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Patients received 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
MEDIAN
population Description
13 of the 32 patients who started treatment had available CT scans containing the target lesions at cycles 3, 6 or 8 for comparison with baseline, and these patients were included in this analysis
reporting Status
POSTED
time Frame
During trial treatment of 8 cycles (224 days), comparing baseline with cycles 3, 6 and 8
title
Maximum Percentage Change in Sum of Product of Diameters
type
SECONDARY
unit Of Measure
percentage change

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

Preserved source evidence · Not medical advice