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NCT02102490 · OUTCOME

Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score

A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread · Source last updated 2020-01-21

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
Cycle 6 Day 1

What was measured

EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.

Analysis population: All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 data.

Groups in this outcome

Abemaciclib

200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.

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

Analysis denominator · Participants

GroupSource count
Abemaciclib59

Reported measurements

Better
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Abemaciclib17Not reportedNot reportedNot reportedNot reported
No Change
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Abemaciclib16Not reportedNot reportedNot reportedNot reported
Worse
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Abemaciclib26Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    Better
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    No Change
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        26
    title
    Worse
denoms
  1. counts
    1. group Id
      OG000
      value
      59
    units
    Participants
description
EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
groups
  1. description
    200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
    id
    OG000
    title
    Abemaciclib
param Type
COUNT_OF_PARTICIPANTS
population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 data.
reporting Status
POSTED
time Frame
Cycle 6 Day 1
title
Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice