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NCT02354508 · OUTCOME

Core 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 12, 24 & 36

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: FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study

Groups in this outcome

Pasireotide LAR Overall

This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

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 Overall123

Reported measurements

Week 12

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall119
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall0.00.15Not reportedNot reportedNot reported
Week 24

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall118
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall0.00.15Not reportedNot reportedNot reported
Week 36

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall111
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall0.00.15Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.15
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        119
      units
      Participants
    title
    Week 12
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.15
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        118
      units
      Participants
    title
    Week 24
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.15
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        111
      units
      Participants
    title
    Week 36
denoms
  1. counts
    1. group Id
      OG000
      value
      123
    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
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
    id
    OG000
    title
    Pasireotide LAR Overall
param Type
MEAN
population Description
FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study
reporting Status
POSTED
time Frame
Baseline, Weeks 12, 24 & 36
title
Core 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