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NCT01885195 · OUTCOME

Number of Participants With Shift From Baseline in Clinical Laboratory - Biochemistry Parameters

MEK162 for Patients With RAS/RAF/MEK Activated Tumors · Source last updated 2021-02-21

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 Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months)

What was measured

Laboratory parameters included hematological and biochemistry parameters. Biochemistry parameters included: creatinine, phosphorus, albumin, gamma-glutamyl transferase, aspartate transaminase, alanine aminotransferase, alkaline phosphatase, total bilirubin, uric acid, amylase, lipase, creatine kinase, total cholesterol and triglycerides. Number of participants with biochemistry test abnormalities by grades (CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Participants with a grade shift of 3 or more from baseline are reported in this outcome measure.

Analysis population: Safety analysis set included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline safety assessment. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

Groups in this outcome

Binimetinib (MEK162)

Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months.

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

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)110

Reported measurements

Creatinine

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)81
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)0Not reportedNot reportedNot reportedNot reported
Phosphorus

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)98
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)1Not reportedNot reportedNot reportedNot reported
Albumin

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)33
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)5Not reportedNot reportedNot reportedNot reported
Gamma-Glutamyl Transferase

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)68
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)1Not reportedNot reportedNot reportedNot reported
Aspartate Transaminase

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)39
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)2Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)76
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)2Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)58
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)0Not reportedNot reportedNot reportedNot reported
Total Bilirubin

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)104
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)0Not reportedNot reportedNot reportedNot reported
Uric Acid

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)91
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)0Not reportedNot reportedNot reportedNot reported
Amylase

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)81
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)2Not reportedNot reportedNot reportedNot reported
Lipase

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)85
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)5Not reportedNot reportedNot reportedNot reported
Creatine Kinase

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)28
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)18Not reportedNot reportedNot reportedNot reported
Total Cholesterol

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)73
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)0Not reportedNot reportedNot reportedNot reported
Triglycerides

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)59
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        81
      units
      Participants
    title
    Creatinine
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        98
      units
      Participants
    title
    Phosphorus
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      units
      Participants
    title
    Albumin
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      units
      Participants
    title
    Gamma-Glutamyl Transferase
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      units
      Participants
    title
    Aspartate Transaminase
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      units
      Participants
    title
    Alanine Aminotransferase
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      units
      Participants
    title
    Alkaline Phosphatase
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        104
      units
      Participants
    title
    Total Bilirubin
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        91
      units
      Participants
    title
    Uric Acid
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        81
      units
      Participants
    title
    Amylase
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        85
      units
      Participants
    title
    Lipase
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      units
      Participants
    title
    Creatine Kinase
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    units
    Participants
description
Laboratory parameters included hematological and biochemistry parameters. Biochemistry parameters included: creatinine, phosphorus, albumin, gamma-glutamyl transferase, aspartate transaminase, alanine aminotransferase, alkaline phosphatase, total bilirubin, uric acid, amylase, lipase, creatine kinase, total cholesterol and triglycerides. Number of participants with biochemistry test abnormalities by grades (CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Participants with a grade shift of 3 or more from baseline are reported in this outcome measure.
groups
  1. description
    Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months.
    id
    OG000
    title
    Binimetinib (MEK162)
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline safety assessment. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
reporting Status
POSTED
time Frame
From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months)
title
Number of Participants With Shift From Baseline in Clinical Laboratory - Biochemistry Parameters
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice