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NCT01885195 · OUTCOME

Number of Participants With Electrocardiogram (ECG) Abnormalities

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

ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcF) in millisecond (msec): greater than equal to (\>=) 450 to less than (\<) 480, \>=480 to \<500, \>=500, increase from baseline \>=30, increase from baseline \>=60; 2) QTc interval adjusted according to Fridericia formula (QTcB) (msec): \>=450 to \<480, \>=480 to \<500, \>=500, increase from baseline \>=30, increase from baseline \>=60. 3) QT (msec): \>=450 to \<480, \>=480 to \<500, \>=500, increase from baseline \>=30, increase from baseline \>=60.

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

QTcF: >=450 to <480 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)15Not reportedNot reportedNot reportedNot reported
QTcF: >=480 to <500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)4Not reportedNot reportedNot reportedNot reported
QTcF: >=500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)1Not reportedNot reportedNot reportedNot reported
QTcF: Increase from baseline >=30 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)20Not reportedNot reportedNot reportedNot reported
QTcF: Increase from baseline >=60 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)3Not reportedNot reportedNot reportedNot reported
QTcB: >=450 to <480 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)13Not reportedNot reportedNot reportedNot reported
QTcB: >=480 to <500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)5Not reportedNot reportedNot reportedNot reported
QTcB: >=500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)8Not reportedNot reportedNot reportedNot reported
QTcB: Increase from baseline >=30 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)53Not reportedNot reportedNot reportedNot reported
QTcB: Increase from baseline >=60 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)29Not reportedNot reportedNot reportedNot reported
QT: >=450 to <480 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)13Not reportedNot reportedNot reportedNot reported
QT: >=480 to <500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)2Not reportedNot reportedNot reportedNot reported
QT: >=500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)2Not reportedNot reportedNot reportedNot reported
QT: Increase from baseline >=30 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)39Not reportedNot reportedNot reportedNot reported
QT: Increase from baseline >=60 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    QTcF: >=450 to <480 msec
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    QTcF: >=480 to <500 msec
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    QTcF: >=500 msec
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    QTcF: Increase from baseline >=30 msec
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    QTcF: Increase from baseline >=60 msec
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    QTcB: >=450 to <480 msec
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    QTcB: >=480 to <500 msec
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    QTcB: >=500 msec
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        53
    title
    QTcB: Increase from baseline >=30 msec
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    title
    QTcB: Increase from baseline >=60 msec
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    QT: >=450 to <480 msec
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    QT: >=480 to <500 msec
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    units
    Participants
description
ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcF) in millisecond (msec): greater than equal to (\>=) 450 to less than (\<) 480, \>=480 to \<500, \>=500, increase from baseline \>=30, increase from baseline \>=60; 2) QTc interval adjusted according to Fridericia formula (QTcB) (msec): \>=450 to \<480, \>=480 to \<500, \>=500, increase from baseline \>=30, increase from baseline \>=60. 3) QT (msec): \>=450 to \<480, \>=480 to \<500, \>=500, increase from baseline \>=30, increase from baseline \>=60.
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 Electrocardiogram (ECG) Abnormalities
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice