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NCT02684006 · OUTCOME

Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit

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
beats per minute
Interval / dispersion
Standard Deviation
Time frame
Baseline (pre-dose on Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7, EOT visit (maximum up to approximately 89 months) (each cycle=42 days)

What was measured

Pulse rate was measured with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes.

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. "Number Analyzed" signifies number of participants evaluable for the specified timepoints.

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 + Axitinib433
Sunitinib439

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib433
Sunitinib439
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib75.412.49Not reportedNot reportedNot reported
Sunitinib75.612.63Not reportedNot reportedNot reported
Change at Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib347
Sunitinib319
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib0.412.77Not reportedNot reportedNot reported
Sunitinib3.110.69Not reportedNot reportedNot reported
Change at Cycle 3, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib338
Sunitinib289
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib0.812.58Not reportedNot reportedNot reported
Sunitinib3.111.34Not reportedNot reportedNot reported
Change at Cycle 4, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib327
Sunitinib244
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib-0.612.79Not reportedNot reportedNot reported
Sunitinib2.810.34Not reportedNot reportedNot reported
Change at Cycle 5, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib319
Sunitinib227
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib-0.512.00Not reportedNot reportedNot reported
Sunitinib2.510.82Not reportedNot reportedNot reported
Change at Cycle 6, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib299
Sunitinib203
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib-1.912.37Not reportedNot reportedNot reported
Sunitinib1.610.75Not reportedNot reportedNot reported
Change at Cycle 7, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib269
Sunitinib182
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib-1.911.69Not reportedNot reportedNot reported
Sunitinib2.110.13Not reportedNot reportedNot reported
Change at End of Treatment

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib196
Sunitinib250
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib2.915.29Not reportedNot reportedNot reported
Sunitinib3.512.27Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.49
        value
        75.4
      2. group Id
        OG001
        spread
        12.63
        value
        75.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        433
      2. group Id
        OG001
        value
        439
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.77
        value
        0.4
      2. group Id
        OG001
        spread
        10.69
        value
        3.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        347
      2. group Id
        OG001
        value
        319
      units
      Participants
    title
    Change at Cycle 2, Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.58
        value
        0.8
      2. group Id
        OG001
        spread
        11.34
        value
        3.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        338
      2. group Id
        OG001
        value
        289
      units
      Participants
    title
    Change at Cycle 3, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.79
        value
        -0.6
      2. group Id
        OG001
        spread
        10.34
        value
        2.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        327
      2. group Id
        OG001
        value
        244
      units
      Participants
    title
    Change at Cycle 4, Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.00
        value
        -0.5
      2. group Id
        OG001
        spread
        10.82
        value
        2.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        319
      2. group Id
        OG001
        value
        227
      units
      Participants
    title
    Change at Cycle 5, Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.37
        value
        -1.9
      2. group Id
        OG001
        spread
        10.75
        value
        1.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        299
      2. group Id
        OG001
        value
        203
      units
      Participants
    title
    Change at Cycle 6, Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.69
        value
        -1.9
      2. group Id
        OG001
        spread
        10.13
        value
        2.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        269
      2. group Id
        OG001
        value
        182
      units
      Participants
    title
    Change at Cycle 7, Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.29
        value
        2.9
      2. group Id
        OG001
        spread
        12.27
        value
        3.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        196
      2. group Id
        OG001
        value
        250
      units
      Participants
    title
    Change at End of Treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      433
    2. group Id
      OG001
      value
      439
    units
    Participants
description
Pulse rate was measured with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes.
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. "Number Analyzed" signifies number of participants evaluable for the specified timepoints.
reporting Status
POSTED
time Frame
Baseline (pre-dose on Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7, EOT visit (maximum up to approximately 89 months) (each cycle=42 days)
title
Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit
type
SECONDARY
unit Of Measure
beats per minute

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Preserved source evidence · Not medical advice