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NCT02684006 · OUTCOME

Number of Participants According to Grade Shift in Hematology Parameters

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 start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)

What was measured

Following hematology parameters were assessed: hemoglobin decreased (anemia), hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cell (WBC) decreased. Laboratory abnormalities were graded as per NCI- CTCAE v 4.03 where, grade(G) 0= non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe, G4=life-threatening consequences and G5=death. Baseline was defined as last assessment prior to first dose of study treatment. Number of participants with a baseline grade of 0 to 4 which shifted to G3-4 post-baseline are reported in this outcome measure. Only non-zero categories for any reporting arm are reported.

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 + Axitinib428
Sunitinib434

Reported measurements

Anemia (Baseline G0 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib3Not reportedNot reportedNot reportedNot reported
Sunitinib9Not reportedNot reportedNot reportedNot reported
Anemia (Baseline G1 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib6Not reportedNot reportedNot reportedNot reported
Sunitinib21Not reportedNot reportedNot reportedNot reported
Anemia (Baseline G2 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib4Not reportedNot reportedNot reportedNot reported
Sunitinib14Not reportedNot reportedNot reportedNot reported
Anemia (Baseline G3 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib0Not reportedNot reportedNot reportedNot reported
Sunitinib2Not reportedNot reportedNot reportedNot reported
Lymphocytes count decreased (Baseline G0 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib21Not reportedNot reportedNot reportedNot reported
Sunitinib53Not reportedNot reportedNot reportedNot reported
Lymphocytes count decreased (Baseline G1 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib11Not reportedNot reportedNot reportedNot reported
Sunitinib18Not reportedNot reportedNot reportedNot reported
Lymphocytes count decreased (Baseline G2 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib7Not reportedNot reportedNot reportedNot reported
Sunitinib15Not reportedNot reportedNot reportedNot reported
Lymphocytes count decreased (Baseline G3 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib2Not reportedNot reportedNot reportedNot reported
Sunitinib6Not reportedNot reportedNot reportedNot reported
Neutrophils count decreased (Baseline G0 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib7Not reportedNot reportedNot reportedNot reported
Sunitinib108Not reportedNot reportedNot reportedNot reported
Neutrophils count decreased (Baseline G1 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib0Not reportedNot reportedNot reportedNot reported
Sunitinib2Not reportedNot reportedNot reportedNot reported
Neutrophils count decreased (Baseline G2 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib0Not reportedNot reportedNot reportedNot reported
Sunitinib1Not reportedNot reportedNot reportedNot reported
Platelets count decreased (Baseline G0 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib3Not reportedNot reportedNot reportedNot reported
Sunitinib61Not reportedNot reportedNot reportedNot reported
Platelets count decreased (Baseline G1 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib1Not reportedNot reportedNot reportedNot reported
Sunitinib6Not reportedNot reportedNot reportedNot reported
WBC decreased (Baseline G0 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib1Not reportedNot reportedNot reportedNot reported
Sunitinib35Not reportedNot reportedNot reportedNot reported
WBC decreased (Baseline G1 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib0Not reportedNot reportedNot reportedNot reported
Sunitinib7Not reportedNot reportedNot reportedNot reported
WBC decreased (Baseline G2 to post-baseline G3-4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib0Not reportedNot reportedNot reportedNot reported
Sunitinib2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        9
    title
    Anemia (Baseline G0 to post-baseline G3-4)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        21
    title
    Anemia (Baseline G1 to post-baseline G3-4)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        14
    title
    Anemia (Baseline G2 to post-baseline G3-4)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Anemia (Baseline G3 to post-baseline G3-4)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        53
    title
    Lymphocytes count decreased (Baseline G0 to post-baseline G3-4)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        18
    title
    Lymphocytes count decreased (Baseline G1 to post-baseline G3-4)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        15
    title
    Lymphocytes count decreased (Baseline G2 to post-baseline G3-4)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        6
    title
    Lymphocytes count decreased (Baseline G3 to post-baseline G3-4)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        108
    title
    Neutrophils count decreased (Baseline G0 to post-baseline G3-4)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Neutrophils count decreased (Baseline G1 to post-baseline G3-4)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Neutrophils count decreased (Baseline G2 to post-baseline G3-4)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        61
    title
    Platelets count decreased (Baseline G0 to post-baseline G3-4)
denoms
  1. counts
    1. group Id
      OG000
      value
      428
    2. group Id
      OG001
      value
      434
    units
    Participants
description
Following hematology parameters were assessed: hemoglobin decreased (anemia), hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cell (WBC) decreased. Laboratory abnormalities were graded as per NCI- CTCAE v 4.03 where, grade(G) 0= non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe, G4=life-threatening consequences and G5=death. Baseline was defined as last assessment prior to first dose of study treatment. Number of participants with a baseline grade of 0 to 4 which shifted to G3-4 post-baseline are reported in this outcome measure. Only non-zero categories for any reporting arm are reported.
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. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)
title
Number of Participants According to Grade Shift in Hematology Parameters
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice