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NCT02354508 · OUTCOME

Extension Phase: Change From Baseline in EQ-5D-5L Index Scores

Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues · Source last updated 2019-12-10

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

Measure
MEAN
Unit
scores on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Weeks 48, 60 & 72

What was measured

Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages - the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.

Analysis population: Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.

Groups in this outcome

Pasireotide LAR Overall

These are the participants in the extension phase who received Pasireotide LAR

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

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall88

Reported measurements

Week 48

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall0
Week 60

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall1
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall-0.10.00Not reportedNot reportedNot reported
Week 72

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall73
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall0.00.08Not reportedNot reportedNot reported
Complete source fields
classes
  1. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Week 48
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.00
        value
        -0.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Week 60
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.08
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      units
      Participants
    title
    Week 72
denoms
  1. counts
    1. group Id
      OG000
      value
      88
    units
    Participants
description
Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages - the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.
dispersion Type
Standard Deviation
groups
  1. description
    These are the participants in the extension phase who received Pasireotide LAR
    id
    OG000
    title
    Pasireotide LAR Overall
param Type
MEAN
population Description
Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.
reporting Status
POSTED
time Frame
Baseline, Weeks 48, 60 & 72
title
Extension Phase: Change From Baseline in EQ-5D-5L Index Scores
type
SECONDARY
unit Of Measure
scores on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice