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NCT01668784 · OUTCOME

Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025) · Source last updated 2022-08-09

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
Day 1 to 30 days post study completion (approximately 106 months)

What was measured

Aspartate aminotransferase, AST. Alanine aminotransaminase, ALT. Total bilirubin, tBIL. Thyroid stimulating hormone, TSH. Upper limit of normal (ULN). Units per Liter (U/L). Results reported in International System of Units (SI).

Analysis population: To all treated participants with evaluable measurements

Groups in this outcome

Nivolumab

Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.

Everolimus

Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.

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

Analysis denominator · Participants

GroupSource count
Nivolumab406
Everolimus397

Reported measurements

ALT or AST > 3.0*ULN

Analysis denominator · Participants

GroupSource count
Nivolumab401
Everolimus377
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab32Not reportedNot reportedNot reportedNot reported
Everolimus15Not reportedNot reportedNot reportedNot reported
ALT or AST > 5.0*ULN

Analysis denominator · Participants

GroupSource count
Nivolumab401
Everolimus377
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab20Not reportedNot reportedNot reportedNot reported
Everolimus7Not reportedNot reportedNot reportedNot reported
ALT or AST > 10.0*ULN

Analysis denominator · Participants

GroupSource count
Nivolumab401
Everolimus377
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab9Not reportedNot reportedNot reportedNot reported
Everolimus1Not reportedNot reportedNot reportedNot reported
ALT or AST > 20.0*ULN

Analysis denominator · Participants

GroupSource count
Nivolumab401
Everolimus377
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab2Not reportedNot reportedNot reportedNot reported
Everolimus0Not reportedNot reportedNot reportedNot reported
Total Bilirubin > 2.0*ULN

Analysis denominator · Participants

GroupSource count
Nivolumab401
Everolimus376
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab6Not reportedNot reportedNot reportedNot reported
Everolimus2Not reportedNot reportedNot reportedNot reported
ALT or AST>3.0*ULN, tBIL>2.0 ULN, 1day

Analysis denominator · Participants

GroupSource count
Nivolumab401
Everolimus376
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab3Not reportedNot reportedNot reportedNot reported
Everolimus0Not reportedNot reportedNot reportedNot reported
ALT or AST>3.0*ULN, tBIL>2.0 ULN,30day

Analysis denominator · Participants

GroupSource count
Nivolumab401
Everolimus376
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab4Not reportedNot reportedNot reportedNot reported
Everolimus1Not reportedNot reportedNot reportedNot reported
TSH > ULN

Analysis denominator · Participants

GroupSource count
Nivolumab382
Everolimus361
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab159Not reportedNot reportedNot reportedNot reported
Everolimus78Not reportedNot reportedNot reportedNot reported
TSH < LLN

Analysis denominator · Participants

GroupSource count
Nivolumab382
Everolimus361
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab60Not reportedNot reportedNot reportedNot reported
Everolimus60Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        15
    denoms
    1. counts
      1. group Id
        OG000
        value
        401
      2. group Id
        OG001
        value
        377
      units
      Participants
    title
    ALT or AST > 3.0*ULN
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        7
    denoms
    1. counts
      1. group Id
        OG000
        value
        401
      2. group Id
        OG001
        value
        377
      units
      Participants
    title
    ALT or AST > 5.0*ULN
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        401
      2. group Id
        OG001
        value
        377
      units
      Participants
    title
    ALT or AST > 10.0*ULN
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        401
      2. group Id
        OG001
        value
        377
      units
      Participants
    title
    ALT or AST > 20.0*ULN
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        401
      2. group Id
        OG001
        value
        376
      units
      Participants
    title
    Total Bilirubin > 2.0*ULN
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        401
      2. group Id
        OG001
        value
        376
      units
      Participants
    title
    ALT or AST>3.0*ULN, tBIL>2.0 ULN, 1day
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        401
      2. group Id
        OG001
        value
        376
      units
      Participants
    title
    ALT or AST>3.0*ULN, tBIL>2.0 ULN,30day
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        159
      2. group Id
        OG001
        value
        78
    denoms
    1. counts
      1. group Id
        OG000
        value
        382
      2. group Id
        OG001
        value
        361
      units
      Participants
    title
    TSH > ULN
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        60
      2. group Id
        OG001
        value
        60
    denoms
    1. counts
      1. group Id
        OG000
        value
        382
      2. group Id
        OG001
        value
        361
      units
      Participants
    title
    TSH < LLN
denoms
  1. counts
    1. group Id
      OG000
      value
      406
    2. group Id
      OG001
      value
      397
    units
    Participants
description
Aspartate aminotransferase, AST. Alanine aminotransaminase, ALT. Total bilirubin, tBIL. Thyroid stimulating hormone, TSH. Upper limit of normal (ULN). Units per Liter (U/L). Results reported in International System of Units (SI).
groups
  1. description
    Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    id
    OG000
    title
    Nivolumab
  2. description
    Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    id
    OG001
    title
    Everolimus
param Type
COUNT_OF_PARTICIPANTS
population Description
To all treated participants with evaluable measurements
reporting Status
POSTED
time Frame
Day 1 to 30 days post study completion (approximately 106 months)
title
Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice