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NCT02928224 · OUTCOME

(Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Final Analysis

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer · Source last updated 2023-12-21

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)

What was measured

An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants according to incidence of dose interruptions, dose modifications and dose discontinuations due to AEs were reported in this outcome measure.

Analysis population: The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 posttreatment assessment, which may have included death. Participants were analyzed according to treatment received.

Groups in this outcome

Combined Safety Lead-in

Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.

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

Analysis denominator · Participants

GroupSource count
Combined Safety Lead-in37

Reported measurements

Dose interruptions
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combined Safety Lead-in30Not reportedNot reportedNot reportedNot reported
Dose modifications
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combined Safety Lead-in16Not reportedNot reportedNot reportedNot reported
Discontinuation due to AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combined Safety Lead-in8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        30
    title
    Dose interruptions
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    Dose modifications
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Discontinuation due to AEs
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    units
    Participants
description
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants according to incidence of dose interruptions, dose modifications and dose discontinuations due to AEs were reported in this outcome measure.
groups
  1. description
    Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
    id
    OG000
    title
    Combined Safety Lead-in
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 posttreatment assessment, which may have included death. Participants were analyzed according to treatment received.
reporting Status
POSTED
time Frame
From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)
title
(Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Final Analysis
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice