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NCT01072175 · OUTCOME

Part D: Overall Survival (OS)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From the date of first dose until date of death due to any cause (up to approximately 7 years)

What was measured

OS is defined as the interval of time between the date of randomization until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact.

Analysis population: ITT Population

Groups in this outcome

Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg

Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.

Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg

Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.

Part D: Dabrafenib 75 mg + Trametinib 2 mg

Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.

Part D: Dabrafenib 150 mg + Trametinib 2 mg

Participants received dabrefinib 150 mg HPMC 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 D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg12
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg16
Part D: Dabrafenib 75 mg + Trametinib 2 mg43
Part D: Dabrafenib 150 mg + Trametinib 2 mg39

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg19.5Not reported12.428.0Not reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg15.5Not reported10.460.0Not reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg15.3Not reported13.037.2Not reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg40.3Not reported15.769.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.4
        upper Limit
        28.0
        value
        19.5
      2. group Id
        OG001
        lower Limit
        10.4
        upper Limit
        60.0
        value
        15.5
      3. group Id
        OG002
        lower Limit
        13.0
        upper Limit
        37.2
        value
        15.3
      4. group Id
        OG003
        lower Limit
        15.7
        upper Limit
        69.6
        value
        40.3
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      43
    4. group Id
      OG003
      value
      39
    units
    Participants
description
OS is defined as the interval of time between the date of randomization until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
    id
    OG000
    title
    Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
  2. description
    Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
    id
    OG001
    title
    Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
  3. description
    Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
    id
    OG002
    title
    Part D: Dabrafenib 75 mg + Trametinib 2 mg
  4. description
    Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
    id
    OG003
    title
    Part D: Dabrafenib 150 mg + Trametinib 2 mg
param Type
MEDIAN
population Description
ITT Population
reporting Status
POSTED
time Frame
From the date of first dose until date of death due to any cause (up to approximately 7 years)
title
Part D: Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

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