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NCT03046953 · OUTCOME

Toxicity- Proportion 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
NUMBER
Unit
proportion of patients
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 proportion of patients who experience one or more grade 3 or 4 adverse event or serious adverse event of any grade

Analysis population: The proportion 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 proportion of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab0.656Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.656
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
description
Toxicity assessed using CTCAE v4.0 will be defined as the proportion 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
NUMBER
population Description
The proportion 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- Proportion of Patients
type
SECONDARY
unit Of Measure
proportion of patients

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

Preserved source evidence · Not medical advice