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NCT02614794 · OUTCOME

Incidence of Health Resources Utilization

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
NUMBER
Unit
hospitalizations
Interval / dispersion
Not reported
Time frame
36.1 months

What was measured

Cumulative incidence of health resource utilization, including length of stay, hospitalizations, and ER visits using the EQ-5D-5L questionnaire.

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

Total number of hospitalizations
Values in hospitalizations · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra143Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra75Not reportedNot reportedNot reportedNot reported
Hospitalization for AE
Values in hospitalizations · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra124Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra64Not reportedNot reportedNot reportedNot reported
Planned hospitalization (other than AE)
Values in hospitalizations · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra10Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra6Not reportedNot reportedNot reportedNot reported
Ambulatory Surgery
Values in hospitalizations · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra3Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra0Not reportedNot reportedNot reportedNot reported
Other
Values in hospitalizations · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tuc+Cap+Tra6Not reportedNot reportedNot reportedNot reported
Pbo+Cap+Tra5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        143
      2. group Id
        OG001
        value
        75
    title
    Total number of hospitalizations
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        124
      2. group Id
        OG001
        value
        64
    title
    Hospitalization for AE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        6
    title
    Planned hospitalization (other than AE)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Ambulatory Surgery
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
    title
    Other
denoms
  1. counts
    1. group Id
      OG000
      value
      404
    2. group Id
      OG001
      value
      197
    units
    Participants
description
Cumulative incidence of health resource utilization, including length of stay, hospitalizations, and ER visits using the EQ-5D-5L questionnaire.
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
NUMBER
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
36.1 months
title
Incidence of Health Resources Utilization
type
SECONDARY
unit Of Measure
hospitalizations

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

Preserved source evidence · Not medical advice