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NCT02684006 · OUTCOME

Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (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
Millimeters of mercury
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

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were 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. "Number Analyzed" signifies number of participants evaluable for the specified time points.

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

Baseline: Sitting SBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib434
Sunitinib439
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib126.513.52Not reportedNot reportedNot reported
Sunitinib126.312.00Not reportedNot reportedNot reported
Change at Cycle 2, Day 1: Sitting SBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib380
Sunitinib344
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib4.716.08Not reportedNot reportedNot reported
Sunitinib0.812.49Not reportedNot reportedNot reported
Change at Cycle 3, Day 1: Sitting SBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib363
Sunitinib310
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib3.816.43Not reportedNot reportedNot reported
Sunitinib1.212.81Not reportedNot reportedNot reported
Change at Cycle 4, Day 1: Sitting SBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib342
Sunitinib271
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib3.015.95Not reportedNot reportedNot reported
Sunitinib0.113.01Not reportedNot reportedNot reported
Change at Cycle 5, Day 1: Sitting SBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib332
Sunitinib244
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib2.515.42Not reportedNot reportedNot reported
Sunitinib-0.112.26Not reportedNot reportedNot reported
Change at Cycle 6, Day 1: Sitting SBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib310
Sunitinib215
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib1.615.39Not reportedNot reportedNot reported
Sunitinib-0.112.97Not reportedNot reportedNot reported
Change at Cycle 7, Day 1: Sitting SBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib282
Sunitinib191
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib1.915.39Not reportedNot reportedNot reported
Sunitinib0.413.56Not reportedNot reportedNot reported
Change at End of Treatment: Sitting SBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib205
Sunitinib273
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib0.917.40Not reportedNot reportedNot reported
Sunitinib1.715.67Not reportedNot reportedNot reported
Baseline: Sitting DBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib434
Sunitinib439
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib75.79.32Not reportedNot reportedNot reported
Sunitinib75.99.41Not reportedNot reportedNot reported
Change at Cycle 2, Day 1: Sitting DBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib380
Sunitinib344
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib5.810.92Not reportedNot reportedNot reported
Sunitinib-0.18.60Not reportedNot reportedNot reported
Change at Cycle 3, Day 1: Sitting DBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib363
Sunitinib310
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib4.910.98Not reportedNot reportedNot reported
Sunitinib0.09.64Not reportedNot reportedNot reported
Change at Cycle 4, Day 1: Sitting DBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib342
Sunitinib271
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib4.811.61Not reportedNot reportedNot reported
Sunitinib-1.99.30Not reportedNot reportedNot reported
Change at Cycle 5, Day 1: Sitting DBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib332
Sunitinib244
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib4.511.17Not reportedNot reportedNot reported
Sunitinib-1.99.71Not reportedNot reportedNot reported
Change at Cycle 6, Day 1: Sitting DBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib310
Sunitinib215
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib3.810.18Not reportedNot reportedNot reported
Sunitinib-1.39.89Not reportedNot reportedNot reported
Change at Cycle 7, Day 1: Sitting DBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib282
Sunitinib191
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib3.811.04Not reportedNot reportedNot reported
Sunitinib-1.19.90Not reportedNot reportedNot reported
Change at End of Treatment: Sitting DBP

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib205
Sunitinib273
Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib1.512.70Not reportedNot reportedNot reported
Sunitinib-0.910.92Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.52
        value
        126.5
      2. group Id
        OG001
        spread
        12.00
        value
        126.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        434
      2. group Id
        OG001
        value
        439
      units
      Participants
    title
    Baseline: Sitting SBP
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.08
        value
        4.7
      2. group Id
        OG001
        spread
        12.49
        value
        0.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        380
      2. group Id
        OG001
        value
        344
      units
      Participants
    title
    Change at Cycle 2, Day 1: Sitting SBP
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.43
        value
        3.8
      2. group Id
        OG001
        spread
        12.81
        value
        1.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        363
      2. group Id
        OG001
        value
        310
      units
      Participants
    title
    Change at Cycle 3, Day 1: Sitting SBP
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.95
        value
        3.0
      2. group Id
        OG001
        spread
        13.01
        value
        0.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        342
      2. group Id
        OG001
        value
        271
      units
      Participants
    title
    Change at Cycle 4, Day 1: Sitting SBP
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.42
        value
        2.5
      2. group Id
        OG001
        spread
        12.26
        value
        -0.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        332
      2. group Id
        OG001
        value
        244
      units
      Participants
    title
    Change at Cycle 5, Day 1: Sitting SBP
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.39
        value
        1.6
      2. group Id
        OG001
        spread
        12.97
        value
        -0.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        310
      2. group Id
        OG001
        value
        215
      units
      Participants
    title
    Change at Cycle 6, Day 1: Sitting SBP
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.39
        value
        1.9
      2. group Id
        OG001
        spread
        13.56
        value
        0.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        282
      2. group Id
        OG001
        value
        191
      units
      Participants
    title
    Change at Cycle 7, Day 1: Sitting SBP
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.40
        value
        0.9
      2. group Id
        OG001
        spread
        15.67
        value
        1.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        205
      2. group Id
        OG001
        value
        273
      units
      Participants
    title
    Change at End of Treatment: Sitting SBP
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.32
        value
        75.7
      2. group Id
        OG001
        spread
        9.41
        value
        75.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        434
      2. group Id
        OG001
        value
        439
      units
      Participants
    title
    Baseline: Sitting DBP
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.92
        value
        5.8
      2. group Id
        OG001
        spread
        8.60
        value
        -0.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        380
      2. group Id
        OG001
        value
        344
      units
      Participants
    title
    Change at Cycle 2, Day 1: Sitting DBP
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.98
        value
        4.9
      2. group Id
        OG001
        spread
        9.64
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        363
      2. group Id
        OG001
        value
        310
      units
      Participants
    title
    Change at Cycle 3, Day 1: Sitting DBP
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.61
        value
        4.8
      2. group Id
        OG001
        spread
        9.30
        value
        -1.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        342
      2. group Id
        OG001
        value
        271
      units
      Participants
    title
    Change at Cycle 4, Day 1: Sitting DBP
denoms
  1. counts
    1. group Id
      OG000
      value
      434
    2. group Id
      OG001
      value
      439
    units
    Participants
description
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were 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. "Number Analyzed" signifies number of participants evaluable for the specified time points.
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 - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit
type
SECONDARY
unit Of Measure
Millimeters of mercury

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Preserved source evidence · Not medical advice