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NCT01266967 · OUTCOME

Number of Participants With Abnormal Echocardiograms (ECHO) at Weeks 4 and 12

A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain · Source last updated 2014-05-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Weeks (W) 4 and 12

What was measured

Echocardiograms (ECHO) were measured for all treated participants. An echocardiogram test gives information about the structure and function of the heart. LLN=lower limit of normal (determined by the institution).

Analysis population: ATS Population

Groups in this outcome

GSK2118436 150 mg: No Prior Local Therapy

Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.

GSK2118436 150 mg: Prior Local Therapy

Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.

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

Analysis denominator · Participants

GroupSource count
GSK2118436 150 mg: No Prior Local Therapy89
GSK2118436 150 mg: Prior Local Therapy83

Reported measurements

W 4, Left ventricle (LV) ejection fraction < LLN
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy1Not reportedNot reportedNot reportedNot reported
GSK2118436 150 mg: Prior Local Therapy0Not reportedNot reportedNot reportedNot reported
W 4, LV ejection fraction < normal
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy0Not reportedNot reportedNot reportedNot reported
GSK2118436 150 mg: Prior Local Therapy0Not reportedNot reportedNot reportedNot reported
W 12, LV ejection fraction < LLN
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy0Not reportedNot reportedNot reportedNot reported
GSK2118436 150 mg: Prior Local Therapy0Not reportedNot reportedNot reportedNot reported
W 12, LV ejection fraction < normal
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy1Not reportedNot reportedNot reportedNot reported
GSK2118436 150 mg: Prior Local Therapy0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    W 4, Left ventricle (LV) ejection fraction < LLN
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    W 4, LV ejection fraction < normal
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    W 12, LV ejection fraction < LLN
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    W 12, LV ejection fraction < normal
denoms
  1. counts
    1. group Id
      OG000
      value
      89
    2. group Id
      OG001
      value
      83
    units
    Participants
description
Echocardiograms (ECHO) were measured for all treated participants. An echocardiogram test gives information about the structure and function of the heart. LLN=lower limit of normal (determined by the institution).
groups
  1. description
    Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
    id
    OG000
    title
    GSK2118436 150 mg: No Prior Local Therapy
  2. description
    Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
    id
    OG001
    title
    GSK2118436 150 mg: Prior Local Therapy
param Type
NUMBER
population Description
ATS Population
reporting Status
POSTED
time Frame
Weeks (W) 4 and 12
title
Number of Participants With Abnormal Echocardiograms (ECHO) at Weeks 4 and 12
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice