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NCT01227889 · OUTCOME

Number of Participants With Non-melanoma Skin Lesions: Randomized Phase

A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma · Source last updated 2017-10-04

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 study completion or discontinuation from the study (up to 9.9 months)

What was measured

Dermatological examinations were performed by the investigator, or at the discretion of the investigator, referred to a dermatologist. The number of participants with non-melanoma skin lessions was assessed from the time of Screening until study completion or discontinuation from the study for any reason.

Analysis population: Safety Population: all randomized participants who received at least one dose of study drug, based on the actual treatment received, if this differed from that to which the participant was randomized

Groups in this outcome

GSK2118436 150 mg BID

Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.

DTIC 1000 mg/m^2 in RP

In the RP, participants received IV DTIC 1000 mg/m\^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.

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 BID187
DTIC 1000 mg/m^2 in RP59

Reported measurements

Number of Subjects with Event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg BID14Not reportedNot reportedNot reportedNot reported
DTIC 1000 mg/m^2 in RP0Not reportedNot reportedNot reportedNot reported
Number of Events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg BID24Not reportedNot reportedNot reportedNot reported
DTIC 1000 mg/m^2 in RP0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        0
    title
    Number of Subjects with Event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        0
    title
    Number of Events
denoms
  1. counts
    1. group Id
      OG000
      value
      187
    2. group Id
      OG001
      value
      59
    units
    Participants
description
Dermatological examinations were performed by the investigator, or at the discretion of the investigator, referred to a dermatologist. The number of participants with non-melanoma skin lessions was assessed from the time of Screening until study completion or discontinuation from the study for any reason.
groups
  1. description
    Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
    id
    OG000
    title
    GSK2118436 150 mg BID
  2. description
    In the RP, participants received IV DTIC 1000 mg/m\^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
    id
    OG001
    title
    DTIC 1000 mg/m^2 in RP
param Type
NUMBER
population Description
Safety Population: all randomized participants who received at least one dose of study drug, based on the actual treatment received, if this differed from that to which the participant was randomized
reporting Status
POSTED
time Frame
From Screening until study completion or discontinuation from the study (up to 9.9 months)
title
Number of Participants With Non-melanoma Skin Lesions: Randomized Phase
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice