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NCT02614794 · OUTCOME

Frequency of Dose Modifications

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
35.1 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+Tra220Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra81Not reportedNot reportedNot reportedNot reported
TEAEs resulting in tucatinib/placebo dose hold
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra216Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra80Not reportedNot reportedNot reportedNot reported
TEAEs resulting in tuc/pbo dose reduction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra84Not 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+Tra313Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra122Not reportedNot reportedNot reportedNot reported
TEAEs resulting in capecitabine dose hold
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra276Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra113Not reportedNot reportedNot reportedNot reported
TEAEs resulting in capecitabine dose reduction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra243Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra77Not reportedNot reportedNot reportedNot reported
TEAEs resulting trastuzumab dose modification
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra104Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra38Not reportedNot reportedNot reportedNot reported
TEAEs resulting in trastuzumab dose hold
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra104Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra38Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        220
      2. group Id
        OG001
        value
        81
    title
    TEAEs resulting in tuc/pbo dose modification
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        216
      2. group Id
        OG001
        value
        80
    title
    TEAEs resulting in tucatinib/placebo dose hold
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        84
      2. group Id
        OG001
        value
        21
    title
    TEAEs resulting in tuc/pbo dose reduction
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        313
      2. group Id
        OG001
        value
        122
    title
    TEAEs resulting capecitabine dose modification
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        276
      2. group Id
        OG001
        value
        113
    title
    TEAEs resulting in capecitabine dose hold
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        243
      2. group Id
        OG001
        value
        77
    title
    TEAEs resulting in capecitabine dose reduction
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        104
      2. group Id
        OG001
        value
        38
    title
    TEAEs resulting trastuzumab dose modification
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        104
      2. group Id
        OG001
        value
        38
    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
35.1 months
title
Frequency of Dose Modifications
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice