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NCT03046953 · OUTCOME

Toxicity- Number of Patients

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
During treatment of 8 cycles (224 days)

What was measured

Toxicity assessed using CTCAE v4.0 will be defined as the number of patients who experience one or more grade 3 or 4 adverse event or serious adverse event of any grade

Analysis population: The number of patients in the per-protocol population who experience one or more grade 3 or 4 adverse event or serious adverse event of any grade

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
Avelumab21Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        21
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
description
Toxicity assessed using CTCAE v4.0 will be defined as the number of patients who experience one or more grade 3 or 4 adverse event or serious adverse event of any grade
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 number of patients in the per-protocol population who experience one or more grade 3 or 4 adverse event or serious adverse event of any grade
reporting Status
POSTED
time Frame
During treatment of 8 cycles (224 days)
title
Toxicity- Number of Patients
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice