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NCT01006980 · OUTCOME

Participants With a Best Overall Response (BOR) of Complete Response or Partial 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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From randomization (initiated January 2010) until December 30, 2010

What was measured

BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Participants who never received study treatment and treated participants without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion and no new lesion.

Analysis population: The analysis population consisted of all ITT participants randomized by September 22, 2010 (at least 14 weeks prior to the clinical cutoff date of December 30, 2010). The 14-week interval was chosen as it was the minimum time needed to observe a confirmed overall response according to protocol-specified schedule for the first two tumor assessments.

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
Vemurafenib219
Dacarbazine220

Reported measurements

Responders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vemurafenib106Not reportedNot reportedNot reportedNot reported
Dacarbazine12Not reportedNot reportedNot reportedNot reported
Non-responders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vemurafenib113Not reportedNot reportedNot reportedNot reported
Dacarbazine208Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        106
      2. group Id
        OG001
        value
        12
    title
    Responders
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        113
      2. group Id
        OG001
        value
        208
    title
    Non-responders
denoms
  1. counts
    1. group Id
      OG000
      value
      219
    2. group Id
      OG001
      value
      220
    units
    Participants
description
BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Participants who never received study treatment and treated participants without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion and no new lesion.
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
NUMBER
population Description
The analysis population consisted of all ITT participants randomized by September 22, 2010 (at least 14 weeks prior to the clinical cutoff date of December 30, 2010). The 14-week interval was chosen as it was the minimum time needed to observe a confirmed overall response according to protocol-specified schedule for the first two tumor assessments.
reporting Status
POSTED
time Frame
From randomization (initiated January 2010) until December 30, 2010
title
Participants With a Best Overall Response (BOR) of Complete Response or Partial Response
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice