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NCT03043313 · OUTCOME

Number of Participants With Clinically Significant Vital Signs: 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

Vital signs included temperature, oxygen saturation, systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and weight. Vital signs were considered clinically significant: temperature: \>= 38 degree Celsius (C); oxygen saturation less than (\<)88%; SBP \>=120 millimeters of mercury (mmHg) or DBP \>=80 mmHg; SBP \>=140 mmHg or DBP \>=90 mmHg; SBP \>=160 mmHg or DBP \>=100 mmHg and heart rate \>100 beats per minute (bpm) and maximum decrease from baseline in weight in kilograms (kg).

Analysis population: The safety analysis set included participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP.

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)86
Tucatinib Post-Crossover (Cohort C)28

Reported measurements

Temperature >=38 degree C
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)1Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
Oxygen saturation <88%
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)8Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)0Not reportedNot reportedNot reportedNot reported
SBP >= 120 mmHg or DBP >= 80 mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)80Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)27Not reportedNot reportedNot reportedNot reported
SBP >= 140 mmHg or DBP >= 90 mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)49Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)13Not reportedNot reportedNot reportedNot reported
SBP >= 160 mmHg or DBP >= 100 mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)21Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)4Not reportedNot reportedNot reportedNot reported
Heart rate > 100 bpm
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)26Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)5Not reportedNot reportedNot reportedNot reported
Maximum decrease from baseline in weight (kg)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tucatinib+Trastuzumab (Cohorts A+B)65Not reportedNot reportedNot reportedNot reported
Tucatinib Post-Crossover (Cohort C)23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Temperature >=38 degree C
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
    title
    Oxygen saturation <88%
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        80
      2. group Id
        OG001
        value
        27
    title
    SBP >= 120 mmHg or DBP >= 80 mmHg
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        13
    title
    SBP >= 140 mmHg or DBP >= 90 mmHg
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        4
    title
    SBP >= 160 mmHg or DBP >= 100 mmHg
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        5
    title
    Heart rate > 100 bpm
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        23
    title
    Maximum decrease from baseline in weight (kg)
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    2. group Id
      OG001
      value
      28
    units
    Participants
description
Vital signs included temperature, oxygen saturation, systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and weight. Vital signs were considered clinically significant: temperature: \>= 38 degree Celsius (C); oxygen saturation less than (\<)88%; SBP \>=120 millimeters of mercury (mmHg) or DBP \>=80 mmHg; SBP \>=140 mmHg or DBP \>=90 mmHg; SBP \>=160 mmHg or DBP \>=100 mmHg and heart rate \>100 beats per minute (bpm) and maximum decrease from baseline in weight in kilograms (kg).
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 participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP.
reporting Status
POSTED
time Frame
Up to 65.1 months
title
Number of Participants With Clinically Significant Vital Signs: Final Analysis
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice