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NCT02614794 · OUTCOME

Incidence of Adverse Events (AEs) 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

What was measured

As determined by assessment of AEs, clinical laboratory tests, and vital signs measurements. AEs were classified by system organ class (SOC) and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA) Version 22.0 or higher; AE severities were classified using Version 4.03 of the (Common Terminology Criteria for Adverse Events) CTCAE criteria.

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

Any treatment-emergent AE (TEAE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra401Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra191Not reportedNot reportedNot reportedNot reported
Any Grade 3 or higher TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra248Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra101Not reportedNot reportedNot reportedNot reported
Any treatment-emergent serious AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra123Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra58Not reportedNot reportedNot reportedNot reported
TEAE leading to death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra8Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        401
      2. group Id
        OG001
        value
        191
    title
    Any treatment-emergent AE (TEAE)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        248
      2. group Id
        OG001
        value
        101
    title
    Any Grade 3 or higher TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        123
      2. group Id
        OG001
        value
        58
    title
    Any treatment-emergent serious AE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        6
    title
    TEAE leading to death
denoms
  1. counts
    1. group Id
      OG000
      value
      404
    2. group Id
      OG001
      value
      197
    units
    Participants
description
As determined by assessment of AEs, clinical laboratory tests, and vital signs measurements. AEs were classified by system organ class (SOC) and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA) Version 22.0 or higher; AE severities were classified using Version 4.03 of the (Common Terminology Criteria for Adverse Events) CTCAE criteria.
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
Incidence of Adverse Events (AEs) 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