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NCT01885195 · OUTCOME

Number of Participants With Shift From Baseline in Clinical Laboratory - Hematology 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. Hematological parameters included neutrophils, platelets, prothrombin time, activated partial thromboplastin time, INR, fibrinogen. Number of participants with hematological abnormalities by grades (as per Common Terminology Criteria for Adverse Events (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

Neutrophils

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)85
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)6Not reportedNot reportedNot reportedNot reported
Platelets

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)77
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)3Not reportedNot reportedNot reportedNot reported
Prothrombin Time

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)73
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)2Not reportedNot reportedNot reportedNot reported
Activated Partial Thromboplastin Time

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)69
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)2Not reportedNot reportedNot reportedNot reported
INR

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)80
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)2Not reportedNot reportedNot reportedNot reported
Fibrinogen

Analysis denominator · Participants

GroupSource count
Binimetinib (MEK162)81
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    denoms
    1. counts
      1. group Id
        OG000
        value
        85
      units
      Participants
    title
    Neutrophils
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        77
      units
      Participants
    title
    Platelets
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      units
      Participants
    title
    Prothrombin Time
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        69
      units
      Participants
    title
    Activated Partial Thromboplastin Time
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        80
      units
      Participants
    title
    INR
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        81
      units
      Participants
    title
    Fibrinogen
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    units
    Participants
description
Laboratory parameters included hematological and biochemistry parameters. Hematological parameters included neutrophils, platelets, prothrombin time, activated partial thromboplastin time, INR, fibrinogen. Number of participants with hematological abnormalities by grades (as per Common Terminology Criteria for Adverse Events (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 - Hematology Parameters
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice