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NCT01885195 · OUTCOME

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03

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

Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated. Treatment-emergent adverse events were defined as new or worsening events that were collected from first study treatment date to last treatment date +30 days. AEs of all grades were reported.

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.

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

Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)2Not reportedNot reportedNot reportedNot reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)27Not reportedNot reportedNot reportedNot reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)64Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)17Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        27
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        64
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    Grade 4
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    units
    Participants
description
Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated. Treatment-emergent adverse events were defined as new or worsening events that were collected from first study treatment date to last treatment date +30 days. AEs of all grades were reported.
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.
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 Treatment Emergent Adverse Events (TEAEs) Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice