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NCT01667419 · OUTCOME

Percentage of Participants With Adverse Events

A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma · Source last updated 2019-07-23

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
From randomization up to study completion or discontinuation (up until 13-July-2018, approximately 6 years)

What was measured

An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.

Analysis population: The safety population included all participants who received at least one dose of study medication.

Groups in this outcome

Cohort 1 Vemurafenib

Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks

Cohort 1 Placebo

Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks

Cohort 2 Vemurafenib

Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks

Cohort 2 Placebo

Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks

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

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib154
Cohort 1 Placebo156
Cohort 2 Vemurafenib93
Cohort 2 Placebo91

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib99.4Not reportedNot reportedNot reportedNot reported
Cohort 1 Placebo88.5Not reportedNot reportedNot reportedNot reported
Cohort 2 Vemurafenib100.0Not reportedNot reportedNot reportedNot reported
Cohort 2 Placebo89.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        99.4
      2. group Id
        OG001
        value
        88.5
      3. group Id
        OG002
        value
        100.0
      4. group Id
        OG003
        value
        89.0
denoms
  1. counts
    1. group Id
      OG000
      value
      154
    2. group Id
      OG001
      value
      156
    3. group Id
      OG002
      value
      93
    4. group Id
      OG003
      value
      91
    units
    Participants
description
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
groups
  1. description
    Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
    id
    OG000
    title
    Cohort 1 Vemurafenib
  2. description
    Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
    id
    OG001
    title
    Cohort 1 Placebo
  3. description
    Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
    id
    OG002
    title
    Cohort 2 Vemurafenib
  4. description
    Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
    id
    OG003
    title
    Cohort 2 Placebo
param Type
NUMBER
population Description
The safety population included all participants who received at least one dose of study medication.
reporting Status
POSTED
time Frame
From randomization up to study completion or discontinuation (up until 13-July-2018, approximately 6 years)
title
Percentage of Participants With Adverse Events
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice