Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01266967 · OUTCOME

Number of Participants With a Worst-case on Therapy Change to Grade 3 and Grade 4, or With Any Grade Increase (AGI), From Baseline Grade for Hematology Parameters

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
From Screening until the conclusion of the study (up to 103 weeks)

What was measured

Hematology data were summarized at each scheduled assessment according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, version 4.0). Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe, Grade 4, life threatening, Grade 5, death related to toxicity. Blood sample was collected for the assessment of hemoglobin, white blood cells, and platelet count.

Analysis population: ATS Population. Only those participants with data available for the indicated parameters were analyzed.

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 Therapy84
GSK2118436 150 mg: Prior Local Therapy81

Reported measurements

Hemoglobin (anemia), AGI
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy25Not reportedNot reportedNot reportedNot reported
GSK2118436 150 mg: Prior Local Therapy81Not reportedNot reportedNot reportedNot reported
Hemoglobin (anemia), Increase to Grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy2Not reportedNot reportedNot reportedNot reported
GSK2118436 150 mg: Prior Local Therapy3Not reportedNot reportedNot reportedNot reported
Hemoglobin (anemia), Increase to Grade 4
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
Hemoglobin (increased), AGI
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
Hemoglobin (increased), Increase to Grade 3
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
Hemoglobin (increased), Increase to Grade 4
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
Lymphocyte count increased, AGI
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
Lymphocyte count increased, Increase to Grade 3
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
Lymphocyte count increased, Increase to Grade 4
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
Lymphocyte count decreased, AGI
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy18Not reportedNot reportedNot reportedNot reported
GSK2118436 150 mg: Prior Local Therapy81Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased, Increase Grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy4Not reportedNot reportedNot reportedNot reported
GSK2118436 150 mg: Prior Local Therapy6Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased, Increase Grade 4
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
Total neutrophils, AGI,
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy6Not reportedNot reportedNot reportedNot reported
GSK2118436 150 mg: Prior Local Therapy11Not reportedNot reportedNot reportedNot reported
Total neutrophils, Increase to Grade 3
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
Total neutrophils, Increase to Grade 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy2Not reportedNot reportedNot reportedNot reported
GSK2118436 150 mg: Prior Local Therapy2Not reportedNot reportedNot reportedNot reported
Platelet count, AGI
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy7Not reportedNot reportedNot reportedNot reported
GSK2118436 150 mg: Prior Local Therapy9Not reportedNot reportedNot reportedNot reported
Platelet count, Increase to Grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy2Not reportedNot reportedNot reportedNot reported
GSK2118436 150 mg: Prior Local Therapy1Not reportedNot reportedNot reportedNot reported
Platelet count, Increase to Grade 4
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
White blood cell count, AGI
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy9Not reportedNot reportedNot reportedNot reported
GSK2118436 150 mg: Prior Local Therapy16Not reportedNot reportedNot reportedNot reported
White blood cell count, Increase to Grade 3
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
White blood cell count, Increase to Grade 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg: No Prior Local Therapy1Not reportedNot reportedNot reportedNot reported
GSK2118436 150 mg: Prior Local Therapy1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        81
    title
    Hemoglobin (anemia), AGI
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
    title
    Hemoglobin (anemia), Increase to Grade 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Hemoglobin (anemia), Increase to Grade 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Hemoglobin (increased), AGI
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Hemoglobin (increased), Increase to Grade 3
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Hemoglobin (increased), Increase to Grade 4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Lymphocyte count increased, AGI
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Lymphocyte count increased, Increase to Grade 3
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Lymphocyte count increased, Increase to Grade 4
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        81
    title
    Lymphocyte count decreased, AGI
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
    title
    Lymphocyte count decreased, Increase Grade 3
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Lymphocyte count decreased, Increase Grade 4
denoms
  1. counts
    1. group Id
      OG000
      value
      84
    2. group Id
      OG001
      value
      81
    units
    Participants
description
Hematology data were summarized at each scheduled assessment according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, version 4.0). Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe, Grade 4, life threatening, Grade 5, death related to toxicity. Blood sample was collected for the assessment of hemoglobin, white blood cells, and platelet count.
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. Only those participants with data available for the indicated parameters were analyzed.
reporting Status
POSTED
time Frame
From Screening until the conclusion of the study (up to 103 weeks)
title
Number of Participants With a Worst-case on Therapy Change to Grade 3 and Grade 4, or With Any Grade Increase (AGI), From Baseline Grade for Hematology Parameters
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice