Mean Scores of SF-12v2 Domain Scores 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, week 17 and 35
What was measured
SF-12v2 General Health Survey is a general patient reported outcome instrument over time. It is scored to provide eight health domain scores (Bodily Pain (BP), General Health (GH), Physical Functioning (PF), Role-Physical (RP), Social Functioning (SF), Role-Emotional (RE), Vitality (VT) and Mental Health (MH)). These eight domain scores can be combined to form two summary scores reflecting overall physical and mental health: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The analyses reported here focus on PCS and MCS scores. The domain scores use a norm-based score, which standardizes the scores with respect to the mean and standard deviation of a nationally representative sample of United States (US) adults. These are the scores on the original scale which have not been transformed in any way. The possible range of scores is 0 to 100, with higher scores representing better outcomes.
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
Group
Source count
All Patients
68
Reported measurements
Baseline Bodily pain scale
Analysis denominator · Participants
Group
Source count
All Patients
68
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
42.9
11.93
Not reported
Not reported
Not reported
Week 17 n=52 Bodily pain scale
Analysis denominator · Participants
Group
Source count
All Patients
52
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
45.1
10.75
Not reported
Not reported
Not reported
Week 35 n=40 Bodily pain scale
Analysis denominator · Participants
Group
Source count
All Patients
40
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
44.9
10.79
Not reported
Not reported
Not reported
Baseline n=67 General health scale:
Analysis denominator · Participants
Group
Source count
All Patients
67
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
38.9
9.23
Not reported
Not reported
Not reported
Week 17 n=52 General health scale:
Analysis denominator · Participants
Group
Source count
All Patients
52
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
40.9
8.52
Not reported
Not reported
Not reported
Week 35 n=40 General health scale:
Analysis denominator · Participants
Group
Source count
All Patients
40
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
40.7
8.94
Not reported
Not reported
Not reported
Baseline n=67 Mental component
Analysis denominator · Participants
Group
Source count
All Patients
67
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
42.4
10.17
Not reported
Not reported
Not reported
Week 17 n=52 Mental component
Analysis denominator · Participants
Group
Source count
All Patients
52
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
41.9
9.68
Not reported
Not reported
Not reported
Week 35 n=40 Mental component
Analysis denominator · Participants
Group
Source count
All Patients
40
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
42.1
8.32
Not reported
Not reported
Not reported
Baseline n=67 Mental health
Analysis denominator · Participants
Group
Source count
All Patients
67
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
41.9
10.48
Not reported
Not reported
Not reported
Week 17 n=52 Mental health
Analysis denominator · Participants
Group
Source count
All Patients
52
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
43.0
9.54
Not reported
Not reported
Not reported
Week 35 n=40 Mental health
Analysis denominator · Participants
Group
Source count
All Patients
40
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
42.4
8.44
Not reported
Not reported
Not reported
Baseline n=67 Physical component summary
Analysis denominator · Participants
Group
Source count
All Patients
67
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
42.7
9.03
Not reported
Not reported
Not reported
Week 17 n=52 Physical component summary
Analysis denominator · Participants
Group
Source count
All Patients
52
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
44.0
8.52
Not reported
Not reported
Not reported
Week 35 n=40 Physical component summary
Analysis denominator · Participants
Group
Source count
All Patients
40
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
43.4
9.59
Not reported
Not reported
Not reported
Baseline n=67 Physical functioning
Analysis denominator · Participants
Group
Source count
All Patients
67
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
42.1
10.17
Not reported
Not reported
Not reported
Week 17 n=52 Physical functioning
Analysis denominator · Participants
Group
Source count
All Patients
52
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
41.9
8.93
Not reported
Not reported
Not reported
Week 35 n=40 Physical functioning
Analysis denominator · Participants
Group
Source count
All Patients
40
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
42.1
11.10
Not reported
Not reported
Not reported
Baseline n=67 Role emotional
Analysis denominator · Participants
Group
Source count
All Patients
67
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
39.7
11.67
Not reported
Not reported
Not reported
Week 17 n=52 Role emotional
Analysis denominator · Participants
Group
Source count
All Patients
52
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
38.0
9.95
Not reported
Not reported
Not reported
Week 35 n=40 Role emotional
Analysis denominator · Participants
Group
Source count
All Patients
40
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
38.7
10.70
Not reported
Not reported
Not reported
Baseline n=67 Role physical scale:
Analysis denominator · Participants
Group
Source count
All Patients
67
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
42.3
10.45
Not reported
Not reported
Not reported
Week 17 n=52 Role physical scale:
Analysis denominator · Participants
Group
Source count
All Patients
52
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
42.8
8.73
Not reported
Not reported
Not reported
Week 35 n=40 Role physical scale:
Analysis denominator · Participants
Group
Source count
All Patients
40
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
41.3
9.63
Not reported
Not reported
Not reported
Baseline n=67 Social functioning
Analysis denominator · Participants
Group
Source count
All Patients
67
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
42.2
11.22
Not reported
Not reported
Not reported
Week 17 n=52 Social functioning
Analysis denominator · Participants
Group
Source count
All Patients
52
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
43.0
8.70
Not reported
Not reported
Not reported
Week 35 n=40 Social functioning
Analysis denominator · Participants
Group
Source count
All Patients
40
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
43.3
9.66
Not reported
Not reported
Not reported
Baseline n=67 Vitality scale:
Analysis denominator · Participants
Group
Source count
All Patients
67
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
47.2
10.02
Not reported
Not reported
Not reported
Week 17 n=52 Vitality scale:
Analysis denominator · Participants
Group
Source count
All Patients
52
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
45.7
10.29
Not reported
Not reported
Not reported
Week 35 n=40 Vitality scale:
Analysis denominator · Participants
Group
Source count
All Patients
40
Values in scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
All Patients
45.6
8.78
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
11.93
value
42.9
denoms
counts
group Id
OG000
value
68
units
Participants
title
Baseline Bodily pain scale
categories
measurements
group Id
OG000
spread
10.75
value
45.1
denoms
counts
group Id
OG000
value
52
units
Participants
title
Week 17 n=52 Bodily pain scale
categories
measurements
group Id
OG000
spread
10.79
value
44.9
denoms
counts
group Id
OG000
value
40
units
Participants
title
Week 35 n=40 Bodily pain scale
categories
measurements
group Id
OG000
spread
9.23
value
38.9
denoms
counts
group Id
OG000
value
67
units
Participants
title
Baseline n=67 General health scale:
categories
measurements
group Id
OG000
spread
8.52
value
40.9
denoms
counts
group Id
OG000
value
52
units
Participants
title
Week 17 n=52 General health scale:
categories
measurements
group Id
OG000
spread
8.94
value
40.7
denoms
counts
group Id
OG000
value
40
units
Participants
title
Week 35 n=40 General health scale:
categories
measurements
group Id
OG000
spread
10.17
value
42.4
denoms
counts
group Id
OG000
value
67
units
Participants
title
Baseline n=67 Mental component
categories
measurements
group Id
OG000
spread
9.68
value
41.9
denoms
counts
group Id
OG000
value
52
units
Participants
title
Week 17 n=52 Mental component
categories
measurements
group Id
OG000
spread
8.32
value
42.1
denoms
counts
group Id
OG000
value
40
units
Participants
title
Week 35 n=40 Mental component
categories
measurements
group Id
OG000
spread
10.48
value
41.9
denoms
counts
group Id
OG000
value
67
units
Participants
title
Baseline n=67 Mental health
categories
measurements
group Id
OG000
spread
9.54
value
43.0
denoms
counts
group Id
OG000
value
52
units
Participants
title
Week 17 n=52 Mental health
categories
measurements
group Id
OG000
spread
8.44
value
42.4
denoms
counts
group Id
OG000
value
40
units
Participants
title
Week 35 n=40 Mental health
denoms
counts
group Id
OG000
value
68
units
Participants
description
SF-12v2 General Health Survey is a general patient reported outcome instrument over time. It is scored to provide eight health domain scores (Bodily Pain (BP), General Health (GH), Physical Functioning (PF), Role-Physical (RP), Social Functioning (SF), Role-Emotional (RE), Vitality (VT) and Mental Health (MH)). These eight domain scores can be combined to form two summary scores reflecting overall physical and mental health: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The analyses reported here focus on PCS and MCS scores. The domain scores use a norm-based score, which standardizes the scores with respect to the mean and standard deviation of a nationally representative sample of United States (US) adults. These are the scores on the original scale which have not been transformed in any way. The possible range of scores is 0 to 100, with higher scores representing better outcomes.
dispersion Type
Standard Deviation
groups
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, week 17 and 35
title
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Triangle