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NCT03043313 · OUTCOME

Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis

Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer · Source last updated 2024-11-26

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
Up to 65.1 months

What was measured

The following hematology laboratory parameters were assessed: Hemoglobin decreased; hemoglobin increased; leukocytes decreased; lymphocytes decreased; neutrophils decreased and Platelets decreased. Treatment emergent laboratory abnormalities were defined as abnormalities that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. NCI CTCAE v4.03 was used for the lab parameters. Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.

Analysis population: The safety analysis set included all participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Groups in this outcome

Tucatinib+Trastuzumab (Cohorts A+B)

Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.

Tucatinib Post-Crossover (Cohort C)

Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.

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

Analysis denominator · Participants

GroupSource count
Tucatinib+Trastuzumab (Cohorts A+B)85
Tucatinib Post-Crossover (Cohort C)28

Reported measurements

Hemoglobin decreased, All grades
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)42Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)9Not reportedNot reportedNot reportedNot reported
Hemoglobin decreased, Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)3Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Hemoglobin decreased, Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)0Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Hemoglobin increased: All grades
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)3Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Hemoglobin increased: Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)0Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Hemoglobin increased: Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)0Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Leukocytes decreased, All grades
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)21Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)5Not reportedNot reportedNot reportedNot reported
Leukocytes decreased, Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)0Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Leukocytes decreased, Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)0Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Lymphocytes decreased, All grades
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)25Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)11Not reportedNot reportedNot reportedNot reported
Lymphocytes decreased, Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)6Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)1Not reportedNot reportedNot reportedNot reported
Lymphocytes decreased, Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)0Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Neutrophils decreased: All grades
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)10Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Neutrophils decreased: Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)0Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Neutrophils decreased: Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)0Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Platelets decreased, All grades
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)15Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)4Not reportedNot reportedNot reportedNot reported
Platelets decreased, Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)0Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Platelets decreased, Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)0Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        9
    title
    Hemoglobin decreased, All grades
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Hemoglobin decreased, Grade 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Hemoglobin decreased, Grade 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Hemoglobin increased: All grades
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Hemoglobin increased: Grade 3
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Hemoglobin increased: Grade 4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        5
    title
    Leukocytes decreased, All grades
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Leukocytes decreased, Grade 3
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Leukocytes decreased, Grade 4
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        11
    title
    Lymphocytes decreased, All grades
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        1
    title
    Lymphocytes decreased, Grade 3
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Lymphocytes decreased, Grade 4
denoms
  1. counts
    1. group Id
      OG000
      value
      85
    2. group Id
      OG001
      value
      28
    units
    Participants
description
The following hematology laboratory parameters were assessed: Hemoglobin decreased; hemoglobin increased; leukocytes decreased; lymphocytes decreased; neutrophils decreased and Platelets decreased. Treatment emergent laboratory abnormalities were defined as abnormalities that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. NCI CTCAE v4.03 was used for the lab parameters. Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.
groups
  1. description
    Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
    id
    OG000
    title
    Tucatinib+Trastuzumab (Cohorts A+B)
  2. description
    Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
    id
    OG001
    title
    Tucatinib Post-Crossover (Cohort C)
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety analysis set included all participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Up to 65.1 months
title
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice