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NCT01006980 · OUTCOME

Time to Confirmed Response

A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3) · Source last updated 2016-09-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
From randomization (initiated January 2010) until December 30, 2010.

What was measured

Time to response was defined as the time from randomization to confirmed response (complete response or partial response).

Analysis population: The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response.

Groups in this outcome

Vemurafenib

Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).

Dacarbazine

Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).

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

Analysis denominator · Participants

GroupSource count
Vemurafenib106
Dacarbazine12

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Vemurafenib1.45Not reported1.05.5Not reported
Dacarbazine2.72Not reported1.65.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        5.5
        value
        1.45
      2. group Id
        OG001
        lower Limit
        1.6
        upper Limit
        5.8
        value
        2.72
denoms
  1. counts
    1. group Id
      OG000
      value
      106
    2. group Id
      OG001
      value
      12
    units
    Participants
description
Time to response was defined as the time from randomization to confirmed response (complete response or partial response).
dispersion Type
Full Range
groups
  1. description
    Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
    id
    OG000
    title
    Vemurafenib
  2. description
    Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
    id
    OG001
    title
    Dacarbazine
param Type
MEDIAN
population Description
The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response.
reporting Status
POSTED
time Frame
From randomization (initiated January 2010) until December 30, 2010.
title
Time to Confirmed Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice