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NCT02354508 · OUTCOME

Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL)

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 Related Quality of Life (HRQoL) was assessed using AcroQoL, an acromegaly-specific quality of life instrument. The AcroQol instrument is comprised of 22 questions divided into two scales: one evaluating physical aspects (8 items) and the other that addresses psychological aspects (14 items). The psychological scale can also be further divided into subscale that evaluates physical appearance and the other subscale focused on the impact of the disease on personal relationships of the patient (7 items each). Each of the questions has a 5-item Likert scale. For each dimension the scores range from 0-4 with 0 being the lowest impact and 4 being the most severe.

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 - AcroQOL Total Scores

This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

Pasireotide LAR Overall - AcroQOL Physical Sub-scores

This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

Pasireotide LAR Overall - AcroQOL Psychological Sub-scores

This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores

This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores

This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

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 Overall - AcroQOL Total Scores88
Pasireotide LAR Overall - AcroQOL Physical Sub-scores88
Pasireotide LAR Overall - AcroQOL Psychological Sub-scores88
Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores88
Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores88

Reported measurements

Week 48

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - AcroQOL Total Scores0
Pasireotide LAR Overall - AcroQOL Physical Sub-scores0
Pasireotide LAR Overall - AcroQOL Psychological Sub-scores0
Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores0
Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores0
Week 60

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - AcroQOL Total Scores1
Pasireotide LAR Overall - AcroQOL Physical Sub-scores1
Pasireotide LAR Overall - AcroQOL Psychological Sub-scores1
Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores1
Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores1
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall - AcroQOL Total Scores-4.50.0Not reportedNot reportedNot reported
Pasireotide LAR Overall - AcroQOL Physical Sub-scores0.00.00Not reportedNot reportedNot reported
Pasireotide LAR Overall - AcroQOL Psychological Sub-scores-7.10.00Not reportedNot reportedNot reported
Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores-3.60.00Not reportedNot reportedNot reported
Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores-10.70.00Not reportedNot reportedNot reported
Week 72

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - AcroQOL Total Scores74
Pasireotide LAR Overall - AcroQOL Physical Sub-scores74
Pasireotide LAR Overall - AcroQOL Psychological Sub-scores73
Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores74
Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores72
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall - AcroQOL Total Scores1.69.72Not reportedNot reportedNot reported
Pasireotide LAR Overall - AcroQOL Physical Sub-scores0.910.61Not reportedNot reportedNot reported
Pasireotide LAR Overall - AcroQOL Psychological Sub-scores1.810.60Not reportedNot reportedNot reported
Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores0.812.82Not reportedNot reportedNot reported
Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores2.911.82Not reportedNot reportedNot reported
Complete source fields
classes
  1. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    Week 48
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0
        value
        -4.5
      2. group Id
        OG001
        spread
        0.00
        value
        0.0
      3. group Id
        OG002
        spread
        0.00
        value
        -7.1
      4. group Id
        OG003
        spread
        0.00
        value
        -3.6
      5. group Id
        OG004
        spread
        0.00
        value
        -10.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    Week 60
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.72
        value
        1.6
      2. group Id
        OG001
        spread
        10.61
        value
        0.9
      3. group Id
        OG002
        spread
        10.60
        value
        1.8
      4. group Id
        OG003
        spread
        12.82
        value
        0.8
      5. group Id
        OG004
        spread
        11.82
        value
        2.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        74
      3. group Id
        OG002
        value
        73
      4. group Id
        OG003
        value
        74
      5. group Id
        OG004
        value
        72
      units
      Participants
    title
    Week 72
denoms
  1. counts
    1. group Id
      OG000
      value
      88
    2. group Id
      OG001
      value
      88
    3. group Id
      OG002
      value
      88
    4. group Id
      OG003
      value
      88
    5. group Id
      OG004
      value
      88
    units
    Participants
description
Evaluation of effect of pasireotide LAR on Health Related Quality of Life (HRQoL) was assessed using AcroQoL, an acromegaly-specific quality of life instrument. The AcroQol instrument is comprised of 22 questions divided into two scales: one evaluating physical aspects (8 items) and the other that addresses psychological aspects (14 items). The psychological scale can also be further divided into subscale that evaluates physical appearance and the other subscale focused on the impact of the disease on personal relationships of the patient (7 items each). Each of the questions has a 5-item Likert scale. For each dimension the scores range from 0-4 with 0 being the lowest impact and 4 being the most severe.
dispersion Type
Standard Deviation
groups
  1. description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
    id
    OG000
    title
    Pasireotide LAR Overall - AcroQOL Total Scores
  2. description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
    id
    OG001
    title
    Pasireotide LAR Overall - AcroQOL Physical Sub-scores
  3. description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
    id
    OG002
    title
    Pasireotide LAR Overall - AcroQOL Psychological Sub-scores
  4. description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
    id
    OG003
    title
    Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores
  5. description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
    id
    OG004
    title
    Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores
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 Scores as Measured by Acromegaly Quality of Life (AcroQoL)
type
SECONDARY
unit Of Measure
scores on a scale

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

Preserved source evidence · Not medical advice