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NCT02684006 · OUTCOME

Number of Participants Who Discontinued Treatment 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months)

What was measured

Number of participants who discontinued treatment due to toxicity are reported in this outcome measure.

Analysis population: Safety analysis set included all participants who received at least one dose of study drug.

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 + Axitinib434
Sunitinib439

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib136Not reported17.41Not reportedNot reported
Sunitinib65Not reported12.82Not reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.41
        value
        136
      2. group Id
        OG001
        lower Limit
        12.82
        value
        65
denoms
  1. counts
    1. group Id
      OG000
      value
      434
    2. group Id
      OG001
      value
      439
    units
    Participants
description
Number of participants who discontinued treatment due to toxicity are reported in this outcome measure.
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
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months)
title
Number of Participants Who Discontinued Treatment Due to Toxicity
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice