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NCT01524978 · OUTCOME

Safety: Percentage of Participants With Adverse Event

A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers · Source last updated 2017-11-20

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
Up to approximately 3 years

What was measured

An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

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

Groups in this outcome

Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib

Participants with NSCLC were treated with vemurafenib monotherapy.

Cohort 2: Ovarian Cancer - Vemurafenib

Participants with ovarian cancer were treated with vemurafenib monotherapy.

Cohort 3a: Colorectal Cancer - Vemurafenib

Participants with colorectal cancer were treated with vemurafenib monotherapy.

Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab

Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.

Cohort 4: Cholangiocarcinoma - Vemurafenib

Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.

Cohort 6: Multiple Myeloma - Vemurafenib

Participants with multiple myeloma were treated with vemurafenib monotherapy.

Cohort 7a: ECD/LCH - Vemurafenib

Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.

Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib

Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.

Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib

Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.

Cohort 7d: Early Stage Astrocytoma - Vemurafenib

Participants with early stage astrocytoma were treated with vemurafenib monotherapy.

Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib

Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.

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: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib62
Cohort 2: Ovarian Cancer - Vemurafenib4
Cohort 3a: Colorectal Cancer - Vemurafenib10
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab27
Cohort 4: Cholangiocarcinoma - Vemurafenib9
Cohort 6: Multiple Myeloma - Vemurafenib9
Cohort 7a: ECD/LCH - Vemurafenib26
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib12
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib12
Cohort 7d: Early Stage Astrocytoma - Vemurafenib9
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib28

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib100Not reportedNot reportedNot reportedNot reported
Cohort 2: Ovarian Cancer - Vemurafenib100Not reportedNot reportedNot reportedNot reported
Cohort 3a: Colorectal Cancer - Vemurafenib100Not reportedNot reportedNot reportedNot reported
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab100Not reportedNot reportedNot reportedNot reported
Cohort 4: Cholangiocarcinoma - Vemurafenib100Not reportedNot reportedNot reportedNot reported
Cohort 6: Multiple Myeloma - Vemurafenib100Not reportedNot reportedNot reportedNot reported
Cohort 7a: ECD/LCH - Vemurafenib100Not reportedNot reportedNot reportedNot reported
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib91.7Not reportedNot reportedNot reportedNot reported
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib100Not reportedNot reportedNot reportedNot reported
Cohort 7d: Early Stage Astrocytoma - Vemurafenib100Not reportedNot reportedNot reportedNot reported
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
      2. group Id
        OG001
        value
        100
      3. group Id
        OG002
        value
        100
      4. group Id
        OG003
        value
        100
      5. group Id
        OG004
        value
        100
      6. group Id
        OG005
        value
        100
      7. group Id
        OG006
        value
        100
      8. group Id
        OG007
        value
        91.7
      9. group Id
        OG008
        value
        100
      10. group Id
        OG009
        value
        100
      11. group Id
        OG010
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      62
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      27
    5. group Id
      OG004
      value
      9
    6. group Id
      OG005
      value
      9
    7. group Id
      OG006
      value
      26
    8. group Id
      OG007
      value
      12
    9. group Id
      OG008
      value
      12
    10. group Id
      OG009
      value
      9
    11. group Id
      OG010
      value
      28
    units
    Participants
description
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
groups
  1. description
    Participants with NSCLC were treated with vemurafenib monotherapy.
    id
    OG000
    title
    Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
  2. description
    Participants with ovarian cancer were treated with vemurafenib monotherapy.
    id
    OG001
    title
    Cohort 2: Ovarian Cancer - Vemurafenib
  3. description
    Participants with colorectal cancer were treated with vemurafenib monotherapy.
    id
    OG002
    title
    Cohort 3a: Colorectal Cancer - Vemurafenib
  4. description
    Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
    id
    OG003
    title
    Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
  5. description
    Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
    id
    OG004
    title
    Cohort 4: Cholangiocarcinoma - Vemurafenib
  6. description
    Participants with multiple myeloma were treated with vemurafenib monotherapy.
    id
    OG005
    title
    Cohort 6: Multiple Myeloma - Vemurafenib
  7. description
    Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
    id
    OG006
    title
    Cohort 7a: ECD/LCH - Vemurafenib
  8. description
    Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
    id
    OG007
    title
    Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
  9. description
    Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
    id
    OG008
    title
    Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
  10. description
    Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
    id
    OG009
    title
    Cohort 7d: Early Stage Astrocytoma - Vemurafenib
  11. description
    Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
    id
    OG010
    title
    Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
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
Up to approximately 3 years
title
Safety: Percentage of Participants With Adverse Event
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice