NCT01283542 · OUTCOME

Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS)

Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma. · Source last updated 2019-04-26

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

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Baseline and at weeks 4, 12,24,48,72, 96

What was measured

The absence and presence of disease-related symptoms were reported by patients and recorded by the medical staff. Patients classified the symptoms according to a 5-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe

Analysis population: number of participants varied across visits

Groups in this outcome

Baseline

Baseline of Main Phase

Week 4

Week 4 of Main Phase

Week 12

Week 12 of Main Phase

Week 24

Week 24 of Main Phase

Week 48

Week 48 of Extension Phase

Week 72

Week 72 of Extension Phase

Week 96

Week 96 of Extension Phase

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
Baseline	20
Week 4	20
Week 12	19
Week 24	20
Week 48	13
Week 72	12
Week 96	11

Reported measurements

Headache Absent

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	45.0	Not reported	Not reported	Not reported	Not reported
Week 4	75.0	Not reported	Not reported	Not reported	Not reported
Week 12	52.6	Not reported	Not reported	Not reported	Not reported
Week 24	45.0	Not reported	Not reported	Not reported	Not reported
Week 48	61.5	Not reported	Not reported	Not reported	Not reported
Week 72	58.3	Not reported	Not reported	Not reported	Not reported
Week 96	70.0	Not reported	Not reported	Not reported	Not reported

Headache Mild

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	30.0	Not reported	Not reported	Not reported	Not reported
Week 4	10.0	Not reported	Not reported	Not reported	Not reported
Week 12	36.8	Not reported	Not reported	Not reported	Not reported
Week 24	45.0	Not reported	Not reported	Not reported	Not reported
Week 48	7.7	Not reported	Not reported	Not reported	Not reported
Week 72	8.3	Not reported	Not reported	Not reported	Not reported
Week 96	0.0	Not reported	Not reported	Not reported	Not reported

Headache Moderate

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	25.0	Not reported	Not reported	Not reported	Not reported
Week 4	15.0	Not reported	Not reported	Not reported	Not reported
Week 12	10.5	Not reported	Not reported	Not reported	Not reported
Week 24	10.0	Not reported	Not reported	Not reported	Not reported
Week 48	30.8	Not reported	Not reported	Not reported	Not reported
Week 72	33.3	Not reported	Not reported	Not reported	Not reported
Week 96	20.0	Not reported	Not reported	Not reported	Not reported

Headache Severe

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	0	Not reported	Not reported	Not reported	Not reported
Week 4	0	Not reported	Not reported	Not reported	Not reported
Week 12	0	Not reported	Not reported	Not reported	Not reported
Week 24	0	Not reported	Not reported	Not reported	Not reported
Week 48	0	Not reported	Not reported	Not reported	Not reported
Week 72	0	Not reported	Not reported	Not reported	Not reported
Week 96	10.0	Not reported	Not reported	Not reported	Not reported

Visual Disturbances Absent

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	80.0	Not reported	Not reported	Not reported	Not reported
Week 4	80.0	Not reported	Not reported	Not reported	Not reported
Week 12	84.2	Not reported	Not reported	Not reported	Not reported
Week 24	85.0	Not reported	Not reported	Not reported	Not reported
Week 48	76.9	Not reported	Not reported	Not reported	Not reported
Week 72	83.3	Not reported	Not reported	Not reported	Not reported
Week 96	80.0	Not reported	Not reported	Not reported	Not reported

Visual Disturbances Mild

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	10.0	Not reported	Not reported	Not reported	Not reported
Week 4	10.0	Not reported	Not reported	Not reported	Not reported
Week 12	10.5	Not reported	Not reported	Not reported	Not reported
Week 24	10.0	Not reported	Not reported	Not reported	Not reported
Week 48	7.7	Not reported	Not reported	Not reported	Not reported
Week 72	0	Not reported	Not reported	Not reported	Not reported
Week 96	0	Not reported	Not reported	Not reported	Not reported

Visual Disturbances Moderate

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	5.0	Not reported	Not reported	Not reported	Not reported
Week 4	5.0	Not reported	Not reported	Not reported	Not reported
Week 12	5.3	Not reported	Not reported	Not reported	Not reported
Week 24	5.0	Not reported	Not reported	Not reported	Not reported
Week 48	15.4	Not reported	Not reported	Not reported	Not reported
Week 72	16.7	Not reported	Not reported	Not reported	Not reported
Week 96	20.0	Not reported	Not reported	Not reported	Not reported

Visual Disturbances Severe

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	5.0	Not reported	Not reported	Not reported	Not reported
Week 4	5.0	Not reported	Not reported	Not reported	Not reported
Week 12	0	Not reported	Not reported	Not reported	Not reported
Week 24	0	Not reported	Not reported	Not reported	Not reported
Week 48	0	Not reported	Not reported	Not reported	Not reported
Week 72	0	Not reported	Not reported	Not reported	Not reported
Week 96	0	Not reported	Not reported	Not reported	Not reported

Fatigue Absent

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	80.0	Not reported	Not reported	Not reported	Not reported
Week 4	80.0	Not reported	Not reported	Not reported	Not reported
Week 12	73.7	Not reported	Not reported	Not reported	Not reported
Week 24	75.0	Not reported	Not reported	Not reported	Not reported
Week 48	69.2	Not reported	Not reported	Not reported	Not reported
Week 72	58.3	Not reported	Not reported	Not reported	Not reported
Week 96	70.0	Not reported	Not reported	Not reported	Not reported

Fatigue Mild

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	15.0	Not reported	Not reported	Not reported	Not reported
Week 4	15.0	Not reported	Not reported	Not reported	Not reported
Week 12	21.1	Not reported	Not reported	Not reported	Not reported
Week 24	20.0	Not reported	Not reported	Not reported	Not reported
Week 48	30.8	Not reported	Not reported	Not reported	Not reported
Week 72	33.3	Not reported	Not reported	Not reported	Not reported
Week 96	30.0	Not reported	Not reported	Not reported	Not reported

Fatigue Moderate

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	5.0	Not reported	Not reported	Not reported	Not reported
Week 4	0	Not reported	Not reported	Not reported	Not reported
Week 12	5.3	Not reported	Not reported	Not reported	Not reported
Week 24	5.0	Not reported	Not reported	Not reported	Not reported
Week 48	0	Not reported	Not reported	Not reported	Not reported
Week 72	8.3	Not reported	Not reported	Not reported	Not reported
Week 96	0	Not reported	Not reported	Not reported	Not reported

Fatigue Severe

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	0	Not reported	Not reported	Not reported	Not reported
Week 4	5.0	Not reported	Not reported	Not reported	Not reported
Week 12	0	Not reported	Not reported	Not reported	Not reported
Week 24	0	Not reported	Not reported	Not reported	Not reported
Week 48	0	Not reported	Not reported	Not reported	Not reported
Week 72	0	Not reported	Not reported	Not reported	Not reported
Week 96	0	Not reported	Not reported	Not reported	Not reported

Decreased libido Absent

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	55.0	Not reported	Not reported	Not reported	Not reported
Week 4	65.0	Not reported	Not reported	Not reported	Not reported
Week 12	68.4	Not reported	Not reported	Not reported	Not reported
Week 24	65.0	Not reported	Not reported	Not reported	Not reported
Week 48	61.5	Not reported	Not reported	Not reported	Not reported
Week 72	66.7	Not reported	Not reported	Not reported	Not reported
Week 96	70.0	Not reported	Not reported	Not reported	Not reported

Decreased libido Mild

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	10.0	Not reported	Not reported	Not reported	Not reported
Week 4	10.0	Not reported	Not reported	Not reported	Not reported
Week 12	10.5	Not reported	Not reported	Not reported	Not reported
Week 24	10.0	Not reported	Not reported	Not reported	Not reported
Week 48	23.1	Not reported	Not reported	Not reported	Not reported
Week 72	25.0	Not reported	Not reported	Not reported	Not reported
Week 96	0	Not reported	Not reported	Not reported	Not reported

Decreased libido Moderate

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	20.0	Not reported	Not reported	Not reported	Not reported
Week 4	10.0	Not reported	Not reported	Not reported	Not reported
Week 12	5.3	Not reported	Not reported	Not reported	Not reported
Week 24	10.0	Not reported	Not reported	Not reported	Not reported
Week 48	0	Not reported	Not reported	Not reported	Not reported
Week 72	0	Not reported	Not reported	Not reported	Not reported
Week 96	20.0	Not reported	Not reported	Not reported	Not reported

Decreased libido Severe

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	5.0	Not reported	Not reported	Not reported	Not reported
Week 4	15.0	Not reported	Not reported	Not reported	Not reported
Week 12	15.8	Not reported	Not reported	Not reported	Not reported
Week 24	15.0	Not reported	Not reported	Not reported	Not reported
Week 48	15.4	Not reported	Not reported	Not reported	Not reported
Week 72	8.3	Not reported	Not reported	Not reported	Not reported
Week 96	10.0	Not reported	Not reported	Not reported	Not reported

Decreased libido Very severe

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	10.0	Not reported	Not reported	Not reported	Not reported
Week 4	0	Not reported	Not reported	Not reported	Not reported
Week 12	0	Not reported	Not reported	Not reported	Not reported
Week 24	0	Not reported	Not reported	Not reported	Not reported
Week 48	0	Not reported	Not reported	Not reported	Not reported
Week 72	0	Not reported	Not reported	Not reported	Not reported
Week 96	0	Not reported	Not reported	Not reported	Not reported

Erectile dysfunction Yes

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	22.2	Not reported	Not reported	Not reported	Not reported
Week 4	11.1	Not reported	Not reported	Not reported	Not reported
Week 12	11.1	Not reported	Not reported	Not reported	Not reported
Week 24	11.1	Not reported	Not reported	Not reported	Not reported
Week 48	0	Not reported	Not reported	Not reported	Not reported
Week 72	0	Not reported	Not reported	Not reported	Not reported
Week 96	0	Not reported	Not reported	Not reported	Not reported

Erectile dysfunction No

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	77.8	Not reported	Not reported	Not reported	Not reported
Week 4	88.9	Not reported	Not reported	Not reported	Not reported
Week 12	88.9	Not reported	Not reported	Not reported	Not reported
Week 24	88.9	Not reported	Not reported	Not reported	Not reported
Week 48	100.0	Not reported	Not reported	Not reported	Not reported
Week 72	100.0	Not reported	Not reported	Not reported	Not reported
Week 96	100.0	Not reported	Not reported	Not reported	Not reported

Regular Menses Yes

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	45.5	Not reported	Not reported	Not reported	Not reported
Week 4	55.6	Not reported	Not reported	Not reported	Not reported
Week 12	62.5	Not reported	Not reported	Not reported	Not reported
Week 24	55.6	Not reported	Not reported	Not reported	Not reported
Week 48	60.0	Not reported	Not reported	Not reported	Not reported
Week 72	50.0	Not reported	Not reported	Not reported	Not reported
Week 96	50.0	Not reported	Not reported	Not reported	Not reported

Regular Menses No

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Baseline	54.5	Not reported	Not reported	Not reported	Not reported
Week 4	44.4	Not reported	Not reported	Not reported	Not reported
Week 12	37.5	Not reported	Not reported	Not reported	Not reported
Week 24	44.4	Not reported	Not reported	Not reported	Not reported
Week 48	40.0	Not reported	Not reported	Not reported	Not reported
Week 72	50.0	Not reported	Not reported	Not reported	Not reported
Week 96	50.0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
45.0
group Id
OG001
value
75.0
group Id
OG002
value
52.6
group Id
OG003
value
45.0
group Id
OG004
value
61.5
group Id
OG005
value
58.3
group Id
OG006
value
70.0
title
Headache Absent
categories
measurements
group Id
OG000
value
30.0
group Id
OG001
value
10.0
group Id
OG002
value
36.8
group Id
OG003
value
45.0
group Id
OG004
value
7.7
group Id
OG005
value
8.3
group Id
OG006
value
0.0
title
Headache Mild
categories
measurements
group Id
OG000
value
25.0
group Id
OG001
value
15.0
group Id
OG002
value
10.5
group Id
OG003
value
10.0
group Id
OG004
value
30.8
group Id
OG005
value
33.3
group Id
OG006
value
20.0
title
Headache Moderate
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
10.0
title
Headache Severe
categories
measurements
group Id
OG000
value
80.0
group Id
OG001
value
80.0
group Id
OG002
value
84.2
group Id
OG003
value
85.0
group Id
OG004
value
76.9
group Id
OG005
value
83.3
group Id
OG006
value
80.0
title
Visual Disturbances Absent
categories
measurements
group Id
OG000
value
10.0
group Id
OG001
value
10.0
group Id
OG002
value
10.5
group Id
OG003
value
10.0
group Id
OG004
value
7.7
group Id
OG005
value
0
group Id
OG006
value
0
title
Visual Disturbances Mild
categories
measurements
group Id
OG000
value
5.0
group Id
OG001
value
5.0
group Id
OG002
value
5.3
group Id
OG003
value
5.0
group Id
OG004
value
15.4
group Id
OG005
value
16.7
group Id
OG006
value
20.0
title
Visual Disturbances Moderate
categories
measurements
group Id
OG000
value
5.0
group Id
OG001
value
5.0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Visual Disturbances Severe
categories
measurements
group Id
OG000
value
80.0
group Id
OG001
value
80.0
group Id
OG002
value
73.7
group Id
OG003
value
75.0
group Id
OG004
value
69.2
group Id
OG005
value
58.3
group Id
OG006
value
70.0
title
Fatigue Absent
categories
measurements
group Id
OG000
value
15.0
group Id
OG001
value
15.0
group Id
OG002
value
21.1
group Id
OG003
value
20.0
group Id
OG004
value
30.8
group Id
OG005
value
33.3
group Id
OG006
value
30.0
title
Fatigue Mild
categories
measurements
group Id
OG000
value
5.0
group Id
OG001
value
0
group Id
OG002
value
5.3
group Id
OG003
value
5.0
group Id
OG004
value
0
group Id
OG005
value
8.3
group Id
OG006
value
0
title
Fatigue Moderate
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
5.0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Fatigue Severe

denoms

counts
group Id
OG000
value
20
group Id
OG001
value
20
group Id
OG002
value
19
group Id
OG003
value
20
group Id
OG004
value
13
group Id
OG005
value
12
group Id
OG006
value
11
units
Participants

description

groups

description
Baseline of Main Phase
id
OG000
title
Baseline
description
Week 4 of Main Phase
id
OG001
title
Week 4
description
Week 12 of Main Phase
id
OG002
title
Week 12
description
Week 24 of Main Phase
id
OG003
title
Week 24
description
Week 48 of Extension Phase
id
OG004
title
Week 48
description
Week 72 of Extension Phase
id
OG005
title
Week 72
description
Week 96 of Extension Phase
id
OG006
title
Week 96

param Type

NUMBER

population Description

number of participants varied across visits

reporting Status

POSTED

time Frame

Baseline and at weeks 4, 12,24,48,72, 96

title

Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS)

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice