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NCT01006980 · OUTCOME

Number of Participants With Adverse Events (AEs)

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

The intensity of AEs was graded according to the NCI Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death). A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution, for example is life-threatening, requires hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or requires intervention to prevent one or other of the outcomes listed above.

Analysis population: The safety population was defined as all treated participants who had at least one on-study assessment. The safety population was analyzed according to the treatment received.

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
Vemurafenib336
Dacarbazine282

Reported measurements

Any adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vemurafenib326Not reportedNot reportedNot reportedNot reported
Dacarbazine253Not reportedNot reportedNot reportedNot reported
Serious adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vemurafenib110Not reportedNot reportedNot reportedNot reported
Dacarbazine45Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        326
      2. group Id
        OG001
        value
        253
    title
    Any adverse event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        110
      2. group Id
        OG001
        value
        45
    title
    Serious adverse event
denoms
  1. counts
    1. group Id
      OG000
      value
      336
    2. group Id
      OG001
      value
      282
    units
    Participants
description
The intensity of AEs was graded according to the NCI Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death). A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution, for example is life-threatening, requires hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or requires intervention to prevent one or other of the outcomes listed above.
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 safety population was defined as all treated participants who had at least one on-study assessment. The safety population was analyzed according to the treatment received.
reporting Status
POSTED
time Frame
From randomization (initiated January 2010) until December 30, 2010.
title
Number of Participants With Adverse Events (AEs)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice