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NCT02684006 · OUTCOME

Time to Treatment Discontinuation/Failure Due to Toxicity

A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) · Source last updated 2025-07-30

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

Measure
MEAN
Unit
Months
Interval / dispersion
Standard Deviation
Time frame
From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months)

What was measured

Time to treatment discontinuation/ failure due to toxicity was defined as the time from first dose of study treatment to discontinuation of study treatment due to an adverse event or death due to study treatment toxicity.

Analysis population: Safety analysis set included all participants who received at least one dose of study drug. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Groups in this outcome

Avelumab + Axitinib

Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.

Sunitinib

Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.

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

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib136
Sunitinib65

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib13.517.41Not reportedNot reportedNot reported
Sunitinib10.512.82Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.41
        value
        13.5
      2. group Id
        OG001
        spread
        12.82
        value
        10.5
denoms
  1. counts
    1. group Id
      OG000
      value
      136
    2. group Id
      OG001
      value
      65
    units
    Participants
description
Time to treatment discontinuation/ failure due to toxicity was defined as the time from first dose of study treatment to discontinuation of study treatment due to an adverse event or death due to study treatment toxicity.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.
    id
    OG000
    title
    Avelumab + Axitinib
  2. description
    Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
    id
    OG001
    title
    Sunitinib
param Type
MEAN
population Description
Safety analysis set included all participants who received at least one dose of study drug. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months)
title
Time to Treatment Discontinuation/Failure Due to Toxicity
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice