NCT02246621 · OUTCOME

Change From Baseline to End of Study in Health Status on the EuroQol-5D 5L Visual Analog Scale (VAS) Scores Scale

A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer · Source last updated 2026-02-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: LEAST_SQUARES_MEAN
Unit: millimeter (mm)
Interval / dispersion: Standard Error
Time frame: Baseline, End of Study (Up to 32 Months)

What was measured

The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). Minimally important differences in the EQ-5D VAS score are 7 or greater in cancer patients. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline.

Analysis population: All randomized participants.

Groups in this outcome

Abemaciclib + NSAI

150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).

Placebo + NSAI

Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).

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

Analysis denominator · Participants

Group	Source count
Abemaciclib + NSAI	328
Placebo + NSAI	165

Reported measurements

Source class 1

Values in millimeter (mm) · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Abemaciclib + NSAI	0.49	0.78	Not reported	Not reported	Not reported
Placebo + NSAI	1.51	1.15	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Num Sides
TWO_SIDED
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
1.39
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.466
param Type
Mean Difference (Net)
param Value
-1.01
statistical Method
Mixed Models Analysis

Complete source fields

analyses

ci Num Sides
TWO_SIDED
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
1.39
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.466
param Type
Mean Difference (Net)
param Value
-1.01
statistical Method
Mixed Models Analysis

classes

categories
measurements
group Id
OG000
spread
0.78
value
0.49
group Id
OG001
spread
1.15
value
1.51

denoms

counts
group Id
OG000
value
328
group Id
OG001
value
165
units
Participants

description

dispersion Type

Standard Error

groups

description
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
id
OG000
title
Abemaciclib + NSAI
description
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
id
OG001
title
Placebo + NSAI

param Type

LEAST_SQUARES_MEAN

population Description

All randomized participants.

reporting Status

POSTED

time Frame

Baseline, End of Study (Up to 32 Months)

title

Change From Baseline to End of Study in Health Status on the EuroQol-5D 5L Visual Analog Scale (VAS) Scores Scale

type

SECONDARY

unit Of Measure

millimeter (mm)

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

Preserved source evidence · Not medical advice