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NCT02155647 · OUTCOME

Part B: Final Analysis: Overall Survival (OS) Time

Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200) · Source last updated 2024-03-13

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
Time from first administration of trial treatment until death (Up to 396 weeks)

What was measured

The OS time was defined as the time from first administration of study treatment until the date of death. OS was calculated using following formula = (date of death - date of the first dose of study treatment + 1)/30.4375 (months).

Analysis population: Full Analysis Set included all participants who received at least 1 dose of study treatment.

Groups in this outcome

Part B: Avelumab

Participants received Avelumab as first-line treatment for metastatic or distally recurrent MCC at a dose of 10 mg/kg as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.

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

Analysis denominator · Participants

GroupSource count
Part B: Avelumab116

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part B: Avelumab20.3Not reported0.565.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        65.8
        value
        20.3
denoms
  1. counts
    1. group Id
      OG000
      value
      116
    units
    Participants
description
The OS time was defined as the time from first administration of study treatment until the date of death. OS was calculated using following formula = (date of death - date of the first dose of study treatment + 1)/30.4375 (months).
dispersion Type
Full Range
groups
  1. description
    Participants received Avelumab as first-line treatment for metastatic or distally recurrent MCC at a dose of 10 mg/kg as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
    id
    OG000
    title
    Part B: Avelumab
param Type
MEDIAN
population Description
Full Analysis Set included all participants who received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
Time from first administration of trial treatment until death (Up to 396 weeks)
title
Part B: Final Analysis: Overall Survival (OS) Time
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice