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NCT01245062 · OUTCOME

PFS Following Cross-over to Trametinib as Assessed by the Investigator

GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma · Source last updated 2018-04-05

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
Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)

What was measured

PFS is defined as the time from the first dose of cross-over therapy to the first documented occurrence of PD or death. PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.

Analysis population: Cross-over Population

Groups in this outcome

Cross-over From Chemotherapy to Trametinib

Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.

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

Analysis denominator · Participants

GroupSource count
Cross-over From Chemotherapy to Trametinib70

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cross-over From Chemotherapy to Trametinib3.0Not reported2.74.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.7
        upper Limit
        4.8
        value
        3.0
denoms
  1. counts
    1. group Id
      OG000
      value
      70
    units
    Participants
description
PFS is defined as the time from the first dose of cross-over therapy to the first documented occurrence of PD or death. PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.
    id
    OG000
    title
    Cross-over From Chemotherapy to Trametinib
param Type
MEDIAN
population Description
Cross-over Population
reporting Status
POSTED
time Frame
Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)
title
PFS Following Cross-over to Trametinib as Assessed by the Investigator
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice