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NCT01072175 · OUTCOME

Part C (Randomized): Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure

Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212 · Source last updated 2019-07-05

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 Baseline (Day 1) until Follow-up visit (up to approximately 7 years)

What was measured

Blood pressure were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred.lood pressure measurement included systolic blood pressure (BP, milimeter of mercury \[mmHg\]) and diastolic BP (DBP). Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value. Heart Rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to \<60 bpm, change to normal or no change, or increase to \>100 bpm are presented.

Analysis population: ATP Population

Groups in this outcome

Part C: Dabrafenib 150 mg

Participants received dabrafenib 150 mg gelatin capsules BID.

Part C: Dabrafenib 150 mg + Trametinib 1 mg

Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.

Part C: Dabrafenib 150 mg + Trametinib 2 mg

Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.

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

Analysis denominator · Participants

GroupSource count
Part C: Dabrafenib 150 mg53
Part C: Dabrafenib 150 mg + Trametinib 1 mg54
Part C: Dabrafenib 150 mg + Trametinib 2 mg55

Reported measurements

Systolic BP (mmHg) , G3 or G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg5Not reportedNot reportedNot reportedNot reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg4Not reportedNot reportedNot reportedNot reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg12Not reportedNot reportedNot reportedNot reported
Diastolic BP (mmHg), G3 or G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg4Not reportedNot reportedNot reportedNot reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg4Not reportedNot reportedNot reportedNot reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg4Not reportedNot reportedNot reportedNot reported
Heart rate, Decrease to <60 bpm
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg9Not reportedNot reportedNot reportedNot reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg8Not reportedNot reportedNot reportedNot reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg11Not reportedNot reportedNot reportedNot reported
Heart rate, Change to normal or no change
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg34Not reportedNot reportedNot reportedNot reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg30Not reportedNot reportedNot reportedNot reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg28Not reportedNot reportedNot reportedNot reported
Heart rate, Increase to >100 bpm
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg10Not reportedNot reportedNot reportedNot reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg16Not reportedNot reportedNot reportedNot reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg18Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        12
    title
    Systolic BP (mmHg) , G3 or G4
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        4
    title
    Diastolic BP (mmHg), G3 or G4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        11
    title
    Heart rate, Decrease to <60 bpm
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        30
      3. group Id
        OG002
        value
        28
    title
    Heart rate, Change to normal or no change
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        16
      3. group Id
        OG002
        value
        18
    title
    Heart rate, Increase to >100 bpm
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      54
    3. group Id
      OG002
      value
      55
    units
    Participants
description
Blood pressure were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred.lood pressure measurement included systolic blood pressure (BP, milimeter of mercury \[mmHg\]) and diastolic BP (DBP). Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value. Heart Rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to \<60 bpm, change to normal or no change, or increase to \>100 bpm are presented.
groups
  1. description
    Participants received dabrafenib 150 mg gelatin capsules BID.
    id
    OG000
    title
    Part C: Dabrafenib 150 mg
  2. description
    Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
    id
    OG001
    title
    Part C: Dabrafenib 150 mg + Trametinib 1 mg
  3. description
    Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
    id
    OG002
    title
    Part C: Dabrafenib 150 mg + Trametinib 2 mg
param Type
NUMBER
population Description
ATP Population
reporting Status
POSTED
time Frame
From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)
title
Part C (Randomized): Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice