Skip to content
TriangleGet started
← Full study record

NCT02928224 · OUTCOME

Phase 3: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities

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 (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)

What was measured

Newly occurring clinically notable changes was defined as participants not meeting the criterion at baseline and meeting criterion post-baseline. The criterion included: low/high systolic blood pressure (SBP): \<= 90 millimeters of mercury (mmHg) with decrease from baseline of \>= 20mmHg or \>= 160mmHg with increase from baseline of \>= 20mmHg, low or high diastolic blood pressure (DBP): \<= 50mmHg with decrease from baseline of \>= 15mmHg or \>= 100mmHg with increase from baseline of \>= 15mmHg, low or high pulse: \<= 50 beats/min with decrease from baseline of \>= 15 beats/min or \>= 120 beats/min with increase from baseline of \>= 15 beats/min, low or high temperature: \<= 36 degree Celsius (deg C) or \>= 37.5 deg C.

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

Groups in this outcome

Phase 3: Triplet Arm

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

Phase 3: Doublet Arm

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

Phase 3: Control Arm

Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.

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

Analysis denominator · Participants

GroupSource count
Phase 3: Triplet Arm222
Phase 3: Doublet Arm216
Phase 3: Control Arm193

Reported measurements

Diastolic Blood Pressure - High
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm8Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm6Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm7Not reportedNot reportedNot reportedNot reported
Diastolic Blood Pressure - Low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm21Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm27Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm5Not reportedNot reportedNot reportedNot reported
Pulse Rate - High
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm23Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm14Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm20Not reportedNot reportedNot reportedNot reported
Pulse Rate - Low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm3Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm4Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm3Not reportedNot reportedNot reportedNot reported
Systolic Blood Pressure - High
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm19Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm13Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm5Not reportedNot reportedNot reportedNot reported
Systolic Blood Pressure - Low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm37Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm28Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm10Not reportedNot reportedNot reportedNot reported
Temperature - High
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm33Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm23Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm25Not reportedNot reportedNot reportedNot reported
Temperature - Low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm93Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm84Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm55Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        7
    title
    Diastolic Blood Pressure - High
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        27
      3. group Id
        OG002
        value
        5
    title
    Diastolic Blood Pressure - Low
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        20
    title
    Pulse Rate - High
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
    title
    Pulse Rate - Low
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        5
    title
    Systolic Blood Pressure - High
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        28
      3. group Id
        OG002
        value
        10
    title
    Systolic Blood Pressure - Low
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        23
      3. group Id
        OG002
        value
        25
    title
    Temperature - High
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        93
      2. group Id
        OG001
        value
        84
      3. group Id
        OG002
        value
        55
    title
    Temperature - Low
denoms
  1. counts
    1. group Id
      OG000
      value
      222
    2. group Id
      OG001
      value
      216
    3. group Id
      OG002
      value
      193
    units
    Participants
description
Newly occurring clinically notable changes was defined as participants not meeting the criterion at baseline and meeting criterion post-baseline. The criterion included: low/high systolic blood pressure (SBP): \<= 90 millimeters of mercury (mmHg) with decrease from baseline of \>= 20mmHg or \>= 160mmHg with increase from baseline of \>= 20mmHg, low or high diastolic blood pressure (DBP): \<= 50mmHg with decrease from baseline of \>= 15mmHg or \>= 100mmHg with increase from baseline of \>= 15mmHg, low or high pulse: \<= 50 beats/min with decrease from baseline of \>= 15 beats/min or \>= 120 beats/min with increase from baseline of \>= 15 beats/min, low or high temperature: \<= 36 degree Celsius (deg C) or \>= 37.5 deg C.
groups
  1. description
    Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
    id
    OG000
    title
    Phase 3: Triplet Arm
  2. description
    Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.
    id
    OG001
    title
    Phase 3: Doublet Arm
  3. description
    Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.
    id
    OG002
    title
    Phase 3: Control Arm
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 post-treatment 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 (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
title
Phase 3: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities
type
SECONDARY
unit Of Measure
Participants

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

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