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NCT02928224 · OUTCOME

Phase 3: Number of Participants With Clinically Notable Shifts in Hematology and Coagulation Laboratory Parameters

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

Clinically notable shifts was defined as worsening by at least 2 grades or to more than or equal to (\>=) Grade 3 based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening and Grade 5: death.

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

Activated Partial Thromboplastin Time - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm9Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm9Not reportedNot reportedNot reportedNot reported
Phase 3:Control Arm4Not reportedNot reportedNot reportedNot reported
Hemoglobin - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm0Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm0Not reportedNot reportedNot reportedNot reported
Phase 3:Control Arm0Not reportedNot reportedNot reportedNot reported
Hemoglobin - Hypo
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm97Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm30Not reportedNot reportedNot reportedNot reported
Phase 3:Control Arm17Not reportedNot reportedNot reportedNot reported
Leukocytes - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm0Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm0Not reportedNot reportedNot reportedNot reported
Phase 3:Control Arm0Not reportedNot reportedNot reportedNot reported
Leukocytes - Hypo
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm2Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm9Not reportedNot reportedNot reportedNot reported
Phase 3:Control Arm51Not reportedNot reportedNot reportedNot reported
Lymphocytes - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm12Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm3Not reportedNot reportedNot reportedNot reported
Phase 3:Control Arm4Not reportedNot reportedNot reportedNot reported
Lymphocytes - Hypo
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm25Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm47Not reportedNot reportedNot reportedNot reported
Phase 3:Control Arm57Not reportedNot reportedNot reportedNot reported
Neutrophils - Hypo
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm4Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm8Not reportedNot reportedNot reportedNot reported
Phase 3:Control Arm65Not reportedNot reportedNot reportedNot reported
Platelets - Hypo
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm1Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm5Not reportedNot reportedNot reportedNot reported
Phase 3:Control Arm4Not reportedNot reportedNot reportedNot reported
Prothrombin Intl. Normalized Ratio - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm3Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm2Not reportedNot reportedNot reportedNot reported
Phase 3:Control Arm2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        4
    title
    Activated Partial Thromboplastin Time - Hyper
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Hemoglobin - Hyper
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        97
      2. group Id
        OG001
        value
        30
      3. group Id
        OG002
        value
        17
    title
    Hemoglobin - Hypo
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Leukocytes - Hyper
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        51
    title
    Leukocytes - Hypo
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        4
    title
    Lymphocytes - Hyper
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        47
      3. group Id
        OG002
        value
        57
    title
    Lymphocytes - Hypo
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        65
    title
    Neutrophils - Hypo
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        4
    title
    Platelets - Hypo
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
    title
    Prothrombin Intl. Normalized Ratio - Hyper
denoms
  1. counts
    1. group Id
      OG000
      value
      222
    2. group Id
      OG001
      value
      216
    3. group Id
      OG002
      value
      193
    units
    Participants
description
Clinically notable shifts was defined as worsening by at least 2 grades or to more than or equal to (\>=) Grade 3 based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening and Grade 5: death.
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 Clinically Notable Shifts in Hematology and Coagulation Laboratory Parameters
type
SECONDARY
unit Of Measure
Participants

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

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