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NCT03141177 · OUTCOME

Number of Participants With Laboratory Values Grade Shifting From Baseline

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma · Source last updated 2026-08-24

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 to 30 days following last dose (Up to 30 Months)

What was measured

Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.

Analysis population: All Treated Participants

Groups in this outcome

Treatment A

Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD

Treatment B

Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD

Treatment C

Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle

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

Analysis denominator · Participants

GroupSource count
Treatment A320
Treatment B50
Treatment C320

Reported measurements

Hemoglobin: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A316
Treatment B49
Treatment C251
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A117Not reportedNot reportedNot reportedNot reported
Treatment B23Not reportedNot reportedNot reportedNot reported
Treatment C190Not reportedNot reportedNot reportedNot reported
Hemoglobin: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A316
Treatment B49
Treatment C251
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A8Not reportedNot reportedNot reportedNot reported
Treatment B5Not reportedNot reportedNot reportedNot reported
Treatment C15Not reportedNot reportedNot reportedNot reported
Platelet Count: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A316
Treatment B48
Treatment C310
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A129Not reportedNot reportedNot reportedNot reported
Treatment B24Not reportedNot reportedNot reportedNot reported
Treatment C216Not reportedNot reportedNot reportedNot reported
Platelet Count: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A316
Treatment B48
Treatment C310
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A2Not reportedNot reportedNot reportedNot reported
Treatment B0Not reportedNot reportedNot reportedNot reported
Treatment C30Not reportedNot reportedNot reportedNot reported
Leukocytes: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A316
Treatment B49
Treatment C311
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A116Not reportedNot reportedNot reportedNot reported
Treatment B26Not reportedNot reportedNot reportedNot reported
Treatment C206Not reportedNot reportedNot reportedNot reported
Leukocytes: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A316
Treatment B49
Treatment C311
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A1Not reportedNot reportedNot reportedNot reported
Treatment B0Not reportedNot reportedNot reportedNot reported
Treatment C16Not reportedNot reportedNot reportedNot reported
Lymphocytes: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A228
Treatment B36
Treatment C225
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A95Not reportedNot reportedNot reportedNot reported
Treatment B20Not reportedNot reportedNot reportedNot reported
Treatment C102Not reportedNot reportedNot reportedNot reported
Lymphocytes: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A228
Treatment B36
Treatment C225
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A15Not reportedNot reportedNot reportedNot reported
Treatment B4Not reportedNot reportedNot reportedNot reported
Treatment C23Not reportedNot reportedNot reportedNot reported
Neutrophil: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A316
Treatment B49
Treatment C311
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A112Not reportedNot reportedNot reportedNot reported
Treatment B22Not reportedNot reportedNot reportedNot reported
Treatment C209Not reportedNot reportedNot reportedNot reported
Neutrophil: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A316
Treatment B49
Treatment C311
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A10Not reportedNot reportedNot reportedNot reported
Treatment B2Not reportedNot reportedNot reportedNot reported
Treatment C36Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A317
Treatment B49
Treatment C310
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A131Not reportedNot reportedNot reportedNot reported
Treatment B31Not reportedNot reportedNot reportedNot reported
Treatment C115Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A317
Treatment B49
Treatment C310
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A9Not reportedNot reportedNot reportedNot reported
Treatment B6Not reportedNot reportedNot reportedNot reported
Treatment C5Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase (AST): Any grade

Analysis denominator · Participants

GroupSource count
Treatment A317
Treatment B49
Treatment C310
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A245Not reportedNot reportedNot reportedNot reported
Treatment B42Not reportedNot reportedNot reportedNot reported
Treatment C177Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase (AST): Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A317
Treatment B49
Treatment C310
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A25Not reportedNot reportedNot reportedNot reported
Treatment B19Not reportedNot reportedNot reportedNot reported
Treatment C8Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase (ALT): Any grade

Analysis denominator · Participants

GroupSource count
Treatment A316
Treatment B49
Treatment C310
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A249Not reportedNot reportedNot reportedNot reported
Treatment B43Not reportedNot reportedNot reportedNot reported
Treatment C121Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase (ALT) Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A316
Treatment B49
Treatment C310
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A31Not reportedNot reportedNot reportedNot reported
Treatment B24Not reportedNot reportedNot reportedNot reported
Treatment C11Not reportedNot reportedNot reportedNot reported
Bilirubin: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A316
Treatment B49
Treatment C309
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A55Not reportedNot reportedNot reportedNot reported
Treatment B17Not reportedNot reportedNot reportedNot reported
Treatment C68Not reportedNot reportedNot reportedNot reported
Bilirubin: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A316
Treatment B49
Treatment C309
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A3Not reportedNot reportedNot reportedNot reported
Treatment B3Not reportedNot reportedNot reportedNot reported
Treatment C3Not reportedNot reportedNot reportedNot reported
Creatinine: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A317
Treatment B49
Treatment C311
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A123Not reportedNot reportedNot reportedNot reported
Treatment B22Not reportedNot reportedNot reportedNot reported
Treatment C132Not reportedNot reportedNot reportedNot reported
Creatinine: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A317
Treatment B49
Treatment C311
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A4Not reportedNot reportedNot reportedNot reported
Treatment B0Not reportedNot reportedNot reportedNot reported
Treatment C2Not reportedNot reportedNot reportedNot reported
Amylase: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A285
Treatment B46
Treatment C277
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A117Not reportedNot reportedNot reportedNot reported
Treatment B26Not reportedNot reportedNot reportedNot reported
Treatment C77Not reportedNot reportedNot reportedNot reported
Amylase: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A285
Treatment B46
Treatment C277
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A28Not reportedNot reportedNot reportedNot reported
Treatment B10Not reportedNot reportedNot reportedNot reported
Treatment C16Not reportedNot reportedNot reportedNot reported
Lipase: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A308
Treatment B47
Treatment C300
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A127Not reportedNot reportedNot reportedNot reported
Treatment B27Not reportedNot reportedNot reportedNot reported
Treatment C114Not reportedNot reportedNot reportedNot reported
Lipase: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A308
Treatment B47
Treatment C300
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A42Not reportedNot reportedNot reportedNot reported
Treatment B20Not reportedNot reportedNot reportedNot reported
Treatment C40Not reportedNot reportedNot reportedNot reported
Hypernatremia: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A317
Treatment B49
Treatment C310
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A33Not reportedNot reportedNot reportedNot reported
Treatment B7Not reportedNot reportedNot reportedNot reported
Treatment C24Not reportedNot reportedNot reportedNot reported
Hypernatremia: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A317
Treatment B49
Treatment C310
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A0Not reportedNot reportedNot reportedNot reported
Treatment B0Not reportedNot reportedNot reportedNot reported
Treatment C0Not reportedNot reportedNot reportedNot reported
Hyponatremia: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A317
Treatment B49
Treatment C310
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A136Not reportedNot reportedNot reportedNot reported
Treatment B30Not reportedNot reportedNot reportedNot reported
Treatment C111Not reportedNot reportedNot reportedNot reported
Hyponatremia: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A317
Treatment B49
Treatment C310
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A34Not reportedNot reportedNot reportedNot reported
Treatment B8Not reportedNot reportedNot reportedNot reported
Treatment C37Not reportedNot reportedNot reportedNot reported
Hyperkalemia: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A317
Treatment B49
Treatment C309
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A111Not reportedNot reportedNot reportedNot reported
Treatment B25Not reportedNot reportedNot reportedNot reported
Treatment C82Not reportedNot reportedNot reportedNot reported
Hyperkalemia: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A317
Treatment B49
Treatment C309
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A15Not reportedNot reportedNot reportedNot reported
Treatment B2Not reportedNot reportedNot reportedNot reported
Treatment C3Not reportedNot reportedNot reportedNot reported
Hypokalemia: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A317
Treatment B49
Treatment C309
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A61Not reportedNot reportedNot reportedNot reported
Treatment B8Not reportedNot reportedNot reportedNot reported
Treatment C35Not reportedNot reportedNot reportedNot reported
Hypokalemia: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A317
Treatment B49
Treatment C309
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A10Not reportedNot reportedNot reportedNot reported
Treatment B0Not reportedNot reportedNot reportedNot reported
Treatment C5Not reportedNot reportedNot reportedNot reported
Hypercalcemia: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A314
Treatment B48
Treatment C309
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A30Not reportedNot reportedNot reportedNot reported
Treatment B7Not reportedNot reportedNot reportedNot reported
Treatment C46Not reportedNot reportedNot reportedNot reported
Hypercalcemia: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A314
Treatment B48
Treatment C309
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A1Not reportedNot reportedNot reportedNot reported
Treatment B0Not reportedNot reportedNot reportedNot reported
Treatment C3Not reportedNot reportedNot reportedNot reported
Hypocalcemia: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A314
Treatment B48
Treatment C309
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A170Not reportedNot reportedNot reportedNot reported
Treatment B25Not reportedNot reportedNot reportedNot reported
Treatment C73Not reportedNot reportedNot reportedNot reported
Hypocalcemia: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A314
Treatment B48
Treatment C309
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A6Not reportedNot reportedNot reportedNot reported
Treatment B2Not reportedNot reportedNot reportedNot reported
Treatment C2Not reportedNot reportedNot reportedNot reported
Hypermagnesemia: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A308
Treatment B49
Treatment C304
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A38Not reportedNot reportedNot reportedNot reported
Treatment B9Not reportedNot reportedNot reportedNot reported
Treatment C26Not reportedNot reportedNot reportedNot reported
Hypermagnesemia: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A308
Treatment B49
Treatment C304
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A12Not reportedNot reportedNot reportedNot reported
Treatment B4Not reportedNot reportedNot reportedNot reported
Treatment C7Not reportedNot reportedNot reportedNot reported
Hypomagnesemia: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A308
Treatment B49
Treatment C304
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A146Not reportedNot reportedNot reportedNot reported
Treatment B16Not reportedNot reportedNot reportedNot reported
Treatment C77Not reportedNot reportedNot reportedNot reported
Hypomagnesemia: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A308
Treatment B49
Treatment C304
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A4Not reportedNot reportedNot reportedNot reported
Treatment B1Not reportedNot reportedNot reportedNot reported
Treatment C1Not reportedNot reportedNot reportedNot reported
Hyperphosphatemia: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A307
Treatment B49
Treatment C307
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A0Not reportedNot reportedNot reportedNot reported
Treatment B0Not reportedNot reportedNot reportedNot reported
Treatment C0Not reportedNot reportedNot reportedNot reported
Hyperphosphatemia: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A307
Treatment B49
Treatment C307
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A0Not reportedNot reportedNot reportedNot reported
Treatment B0Not reportedNot reportedNot reportedNot reported
Treatment C0Not reportedNot reportedNot reportedNot reported
Hypophosphatemia: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A307
Treatment B49
Treatment C307
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A211Not reportedNot reportedNot reportedNot reported
Treatment B33Not reportedNot reportedNot reportedNot reported
Treatment C147Not reportedNot reportedNot reportedNot reported
Hypophosphatemia: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A307
Treatment B49
Treatment C307
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A85Not reportedNot reportedNot reportedNot reported
Treatment B12Not reportedNot reportedNot reportedNot reported
Treatment C31Not reportedNot reportedNot reportedNot reported
Hyperglycemia: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A170
Treatment B33
Treatment C173
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A74Not reportedNot reportedNot reportedNot reported
Treatment B17Not reportedNot reportedNot reportedNot reported
Treatment C76Not reportedNot reportedNot reportedNot reported
Hyperglycemia: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A170
Treatment B33
Treatment C173
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A6Not reportedNot reportedNot reportedNot reported
Treatment B2Not reportedNot reportedNot reportedNot reported
Treatment C3Not reportedNot reportedNot reportedNot reported
Hypoglycemia: Any grade

Analysis denominator · Participants

GroupSource count
Treatment A262
Treatment B45
Treatment C270
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A67Not reportedNot reportedNot reportedNot reported
Treatment B9Not reportedNot reportedNot reportedNot reported
Treatment C37Not reportedNot reportedNot reportedNot reported
Hypoglycemia: Grade 3-4

Analysis denominator · Participants

GroupSource count
Treatment A262
Treatment B45
Treatment C270
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment A2Not reportedNot reportedNot reportedNot reported
Treatment B1Not reportedNot reportedNot reportedNot reported
Treatment C1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        117
      2. group Id
        OG001
        value
        23
      3. group Id
        OG002
        value
        190
    denoms
    1. counts
      1. group Id
        OG000
        value
        316
      2. group Id
        OG001
        value
        49
      3. group Id
        OG002
        value
        251
      units
      Participants
    title
    Hemoglobin: Any grade
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        15
    denoms
    1. counts
      1. group Id
        OG000
        value
        316
      2. group Id
        OG001
        value
        49
      3. group Id
        OG002
        value
        251
      units
      Participants
    title
    Hemoglobin: Grade 3-4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        129
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        216
    denoms
    1. counts
      1. group Id
        OG000
        value
        316
      2. group Id
        OG001
        value
        48
      3. group Id
        OG002
        value
        310
      units
      Participants
    title
    Platelet Count: Any grade
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        30
    denoms
    1. counts
      1. group Id
        OG000
        value
        316
      2. group Id
        OG001
        value
        48
      3. group Id
        OG002
        value
        310
      units
      Participants
    title
    Platelet Count: Grade 3-4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        116
      2. group Id
        OG001
        value
        26
      3. group Id
        OG002
        value
        206
    denoms
    1. counts
      1. group Id
        OG000
        value
        316
      2. group Id
        OG001
        value
        49
      3. group Id
        OG002
        value
        311
      units
      Participants
    title
    Leukocytes: Any grade
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        16
    denoms
    1. counts
      1. group Id
        OG000
        value
        316
      2. group Id
        OG001
        value
        49
      3. group Id
        OG002
        value
        311
      units
      Participants
    title
    Leukocytes: Grade 3-4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        102
    denoms
    1. counts
      1. group Id
        OG000
        value
        228
      2. group Id
        OG001
        value
        36
      3. group Id
        OG002
        value
        225
      units
      Participants
    title
    Lymphocytes: Any grade
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        23
    denoms
    1. counts
      1. group Id
        OG000
        value
        228
      2. group Id
        OG001
        value
        36
      3. group Id
        OG002
        value
        225
      units
      Participants
    title
    Lymphocytes: Grade 3-4
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        112
      2. group Id
        OG001
        value
        22
      3. group Id
        OG002
        value
        209
    denoms
    1. counts
      1. group Id
        OG000
        value
        316
      2. group Id
        OG001
        value
        49
      3. group Id
        OG002
        value
        311
      units
      Participants
    title
    Neutrophil: Any grade
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        36
    denoms
    1. counts
      1. group Id
        OG000
        value
        316
      2. group Id
        OG001
        value
        49
      3. group Id
        OG002
        value
        311
      units
      Participants
    title
    Neutrophil: Grade 3-4
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        131
      2. group Id
        OG001
        value
        31
      3. group Id
        OG002
        value
        115
    denoms
    1. counts
      1. group Id
        OG000
        value
        317
      2. group Id
        OG001
        value
        49
      3. group Id
        OG002
        value
        310
      units
      Participants
    title
    Alkaline Phosphatase: Any grade
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        317
      2. group Id
        OG001
        value
        49
      3. group Id
        OG002
        value
        310
      units
      Participants
    title
    Alkaline Phosphatase: Grade 3-4
denoms
  1. counts
    1. group Id
      OG000
      value
      320
    2. group Id
      OG001
      value
      50
    3. group Id
      OG002
      value
      320
    units
    Participants
description
Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.
groups
  1. description
    Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
    id
    OG000
    title
    Treatment A
  2. description
    Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
    id
    OG001
    title
    Treatment B
  3. description
    Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
    id
    OG002
    title
    Treatment C
param Type
COUNT_OF_PARTICIPANTS
population Description
All Treated Participants
reporting Status
POSTED
time Frame
From first dose to 30 days following last dose (Up to 30 Months)
title
Number of Participants With Laboratory Values Grade Shifting From Baseline
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice