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NCT01915303 · OUTCOME

Mean Scores of Cushing QoL Standardized Score at Week 17 and 35

Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's Disease · Source last updated 2020-09-18

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 and week 17 and 35

What was measured

Patients who completed nine or more items for the 12-item Cushing's syndrome QoL questionaire were considered evaluable for that assessment. Raw scores were obtained for the 12 items using the following scoring: 1) always or very much, 2) often or quite a bit, 3) sometimes or somewhat, 4) rarely or very little, 5) never or not at all. Then the standardized score, Y, was calculated for each patient as follows: Y = 100\* (X - n) / n\*5 - n\*1) = 100 \* (X - n) / 4\*n where X denoted the raw score and n the number of questions answered by the patient. The higher the score, the better the QoL. The best possible standardized score was 100 and the worst possible standardized score was 0

Analysis population: Full analysis set

Groups in this outcome

All Patients

Pasireotide montherapy (0.6 mg bid to 0.9 mg bid) was administered until the biochemical control was achieved and if not achieved, a combination was administered: pasireotide (0.9 mg bid) + cabergoline (0.5 QD to 1 mg QD). Patients were able to add cabergoline at anytime during core and extension

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

Analysis denominator · Participants

GroupSource count
All Patients68

Reported measurements

Baseline Mean

Analysis denominator · Participants

GroupSource count
All Patients68
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Patients41.620.2Not reportedNot reportedNot reported
Week 17 n=54

Analysis denominator · Participants

GroupSource count
All Patients54
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Patients46.319.7Not reportedNot reportedNot reported
Week 35 n=40

Analysis denominator · Participants

GroupSource count
All Patients40
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Patients47.620.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.2
        value
        41.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      units
      Participants
    title
    Baseline Mean
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.7
        value
        46.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      units
      Participants
    title
    Week 17 n=54
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.8
        value
        47.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      units
      Participants
    title
    Week 35 n=40
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    units
    Participants
description
Patients who completed nine or more items for the 12-item Cushing's syndrome QoL questionaire were considered evaluable for that assessment. Raw scores were obtained for the 12 items using the following scoring: 1) always or very much, 2) often or quite a bit, 3) sometimes or somewhat, 4) rarely or very little, 5) never or not at all. Then the standardized score, Y, was calculated for each patient as follows: Y = 100\* (X - n) / n\*5 - n\*1) = 100 \* (X - n) / 4\*n where X denoted the raw score and n the number of questions answered by the patient. The higher the score, the better the QoL. The best possible standardized score was 100 and the worst possible standardized score was 0
dispersion Type
Standard Deviation
groups
  1. description
    Pasireotide montherapy (0.6 mg bid to 0.9 mg bid) was administered until the biochemical control was achieved and if not achieved, a combination was administered: pasireotide (0.9 mg bid) + cabergoline (0.5 QD to 1 mg QD). Patients were able to add cabergoline at anytime during core and extension
    id
    OG000
    title
    All Patients
param Type
MEAN
population Description
Full analysis set
reporting Status
POSTED
time Frame
Baseline and week 17 and 35
title
Mean Scores of Cushing QoL Standardized Score at Week 17 and 35
type
SECONDARY
unit Of Measure
scores on a scale

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

Preserved source evidence · Not medical advice