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NCT02614794 · OUTCOME

Frequency of Dose Modifications at Time of Final Analysis

A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer · Source last updated 2023-08-14

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 60.1 months

Analysis population: Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment (tucatinib/placebo, trastuzumab, or capecitabine), with participants allocated to the treatment group associated with the regimen actually received.

Groups in this outcome

Tuc+Cap+Tra

Tucatinib in combination with capecitabine \& trastuzumab

Pbo+Cap+Tra

Placebo in combination with capecitabine \& trastuzumab

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

Analysis denominator · Participants

GroupSource count
Tuc+Cap+Tra404
Pbo+Cap+Tra197

Reported measurements

TEAEs resulting in tuc/pbo dose modification
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra237Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra85Not reportedNot reportedNot reportedNot reported
TEAEs resulting in tucatinib/placebo dose hold
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra232Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra84Not reportedNot reportedNot reportedNot reported
TEAEs resulting in tuc/pbo dose reduction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra92Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra21Not reportedNot reportedNot reportedNot reported
TEAEs resulting capecitabine dose modification
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra322Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra125Not reportedNot reportedNot reportedNot reported
TEAEs resulting in capecitabine dose hold
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra288Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra117Not reportedNot reportedNot reportedNot reported
TEAEs resulting in capecitabine dose reduction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra251Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra79Not reportedNot reportedNot reportedNot reported
TEAEs resulting trastuzumab dose modification
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra117Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra41Not reportedNot reportedNot reportedNot reported
TEAEs resulting in trastuzumab dose hold
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra117Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra41Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        237
      2. group Id
        OG001
        value
        85
    title
    TEAEs resulting in tuc/pbo dose modification
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        232
      2. group Id
        OG001
        value
        84
    title
    TEAEs resulting in tucatinib/placebo dose hold
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        92
      2. group Id
        OG001
        value
        21
    title
    TEAEs resulting in tuc/pbo dose reduction
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        322
      2. group Id
        OG001
        value
        125
    title
    TEAEs resulting capecitabine dose modification
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        288
      2. group Id
        OG001
        value
        117
    title
    TEAEs resulting in capecitabine dose hold
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        251
      2. group Id
        OG001
        value
        79
    title
    TEAEs resulting in capecitabine dose reduction
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        117
      2. group Id
        OG001
        value
        41
    title
    TEAEs resulting trastuzumab dose modification
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        117
      2. group Id
        OG001
        value
        41
    title
    TEAEs resulting in trastuzumab dose hold
denoms
  1. counts
    1. group Id
      OG000
      value
      404
    2. group Id
      OG001
      value
      197
    units
    Participants
groups
  1. description
    Tucatinib in combination with capecitabine \& trastuzumab
    id
    OG000
    title
    Tuc+Cap+Tra
  2. description
    Placebo in combination with capecitabine \& trastuzumab
    id
    OG001
    title
    Pbo+Cap+Tra
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment (tucatinib/placebo, trastuzumab, or capecitabine), with participants allocated to the treatment group associated with the regimen actually received.
reporting Status
POSTED
time Frame
Up to 60.1 months
title
Frequency of Dose Modifications at Time of Final Analysis
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice