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NCT05654623 · OUTCOME

Change From Baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Index and Visual Analogue Scale (VAS) Scores

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This outcome was registered, but no numerical results were posted in the captured record.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
From baseline up to 28 days after last dose of study treatment

What was measured

The EQ-5D-5L was a 5-item participant-completed questionnaire designed to assess health status in terms of a single index value or utility score. There were 2 components, a Health State Profile where participants rated their level of problems (1=none, 2=slight, 3=moderate, 4=severe, 5=extreme/unable) in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a visual analogue scale (VAS) in which participants rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). Responses to 5 dimensions comprised health state/ single utility index value. E.g. if a participant responds "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses) had a unique predefined utility index value assigned to it per US value sets, Overall index scores ranged from 0 to 1, with lower scores representing a higher level of dysfunction.

Groups in this outcome

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

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
anticipated Posting Date
2029-05
denom Units Selected
Participants
description
The EQ-5D-5L was a 5-item participant-completed questionnaire designed to assess health status in terms of a single index value or utility score. There were 2 components, a Health State Profile where participants rated their level of problems (1=none, 2=slight, 3=moderate, 4=severe, 5=extreme/unable) in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a visual analogue scale (VAS) in which participants rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). Responses to 5 dimensions comprised health state/ single utility index value. E.g. if a participant responds "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses) had a unique predefined utility index value assigned to it per US value sets, Overall index scores ranged from 0 to 1, with lower scores representing a higher level of dysfunction.
reporting Status
NOT_POSTED
time Frame
From baseline up to 28 days after last dose of study treatment
title
Change From Baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Index and Visual Analogue Scale (VAS) Scores
type
SECONDARY

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Preserved source evidence · Not medical advice