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NCT01885195 · OUTCOME

Overall Survival (OS)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From the date of first dose to the date of death due to any cause (maximum up to 19.4 months)

What was measured

OS was defined as the time from the date of first dose to the date of death due to any cause. If a participant was not known to have died, survival time was censored at the date of last contact.

Analysis population: Full analysis set included all the participants who had received at least 1 dose of study drug.

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

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Binimetinib (MEK162)8.5Not reported6.611.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.6
        upper Limit
        11.8
        value
        8.5
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    units
    Participants
description
OS was defined as the time from the date of first dose to the date of death due to any cause. If a participant was not known to have died, survival time was censored at the date of last contact.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
Full analysis set included all the participants who had received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
From the date of first dose to the date of death due to any cause (maximum up to 19.4 months)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice