Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE)
An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease. · Source last updated 2018-06-19
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 up to approximately 256 weeks
What was measured
Only AEs occurring on or after the start of study treatment and no more than 28 days after the discontinuation of study treatment. A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple severity grades for an AE while on a treatment, is only counted under the maximum grade.
Analysis population: Three additional arms were created to display subset of subjects with specific criteria.
Groups in this outcome
600 µg Bid - All Grades
All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.
600 μg - Grades 3/4
Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients
900 μg - All Grades
All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
900 μg - Grades 3/4
Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg
All Patients - All Grades
All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
All Patients - Grades 3/4
All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
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
600 µg Bid - All Grades
49
600 μg - Grades 3/4
49
900 μg - All Grades
55
900 μg - Grades 3/4
55
All Patients - All Grades
104
All Patients - Grades 3/4
104
Reported measurements
Any primary system organ class
Analysis denominator · Participants
Group
Source count
600 µg Bid - All Grades
49
600 μg - Grades 3/4
49
900 μg - All Grades
55
900 μg - Grades 3/4
55
All Patients - All Grades
104
All Patients - Grades 3/4
104
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
600 µg Bid - All Grades
53.1
Not reported
Not reported
Not reported
Not reported
600 μg - Grades 3/4
53.1
Not reported
Not reported
Not reported
Not reported
900 μg - All Grades
29.1
Not reported
Not reported
Not reported
Not reported
900 μg - Grades 3/4
27.3
Not reported
Not reported
Not reported
Not reported
All Patients - All Grades
40.4
Not reported
Not reported
Not reported
Not reported
All Patients - Grades 3/4
39.4
Not reported
Not reported
Not reported
Not reported
Metabolism and nutrition disorders
Analysis denominator · Participants
Group
Source count
600 µg Bid - All Grades
49
600 μg - Grades 3/4
26
900 μg - All Grades
55
900 μg - Grades 3/4
55
All Patients - All Grades
104
All Patients - Grades 3/4
104
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
600 µg Bid - All Grades
26.5
Not reported
Not reported
Not reported
Not reported
600 μg - Grades 3/4
26.5
Not reported
Not reported
Not reported
Not reported
900 μg - All Grades
12.7
Not reported
Not reported
Not reported
Not reported
900 μg - Grades 3/4
10.9
Not reported
Not reported
Not reported
Not reported
All Patients - All Grades
19.2
Not reported
Not reported
Not reported
Not reported
All Patients - Grades 3/4
18.3
Not reported
Not reported
Not reported
Not reported
Gastrointestinal disorders
Analysis denominator · Participants
Group
Source count
600 µg Bid - All Grades
49
600 μg - Grades 3/4
49
900 μg - All Grades
55
900 μg - Grades 3/4
55
All Patients - All Grades
104
All Patients - Grades 3/4
104
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
600 µg Bid - All Grades
18.4
Not reported
Not reported
Not reported
Not reported
600 μg - Grades 3/4
18.4
Not reported
Not reported
Not reported
Not reported
900 μg - All Grades
7.3
Not reported
Not reported
Not reported
Not reported
900 μg - Grades 3/4
7.3
Not reported
Not reported
Not reported
Not reported
All Patients - All Grades
12.5
Not reported
Not reported
Not reported
Not reported
All Patients - Grades 3/4
12.5
Not reported
Not reported
Not reported
Not reported
Investigations
Analysis denominator · Participants
Group
Source count
600 µg Bid - All Grades
49
600 μg - Grades 3/4
49
900 μg - All Grades
55
900 μg - Grades 3/4
55
All Patients - All Grades
104
All Patients - Grades 3/4
104
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
600 µg Bid - All Grades
8.2
Not reported
Not reported
Not reported
Not reported
600 μg - Grades 3/4
8.2
Not reported
Not reported
Not reported
Not reported
900 μg - All Grades
3.6
Not reported
Not reported
Not reported
Not reported
900 μg - Grades 3/4
3.6
Not reported
Not reported
Not reported
Not reported
All Patients - All Grades
5.8
Not reported
Not reported
Not reported
Not reported
All Patients - Grades 3/4
5.8
Not reported
Not reported
Not reported
Not reported
Hepatobiliary disorders
Analysis denominator · Participants
Group
Source count
600 µg Bid - All Grades
49
600 μg - Grades 3/4
49
900 μg - All Grades
55
900 μg - Grades 3/4
55
All Patients - All Grades
104
All Patients - Grades 3/4
104
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
600 µg Bid - All Grades
2.0
Not reported
Not reported
Not reported
Not reported
600 μg - Grades 3/4
2.0
Not reported
Not reported
Not reported
Not reported
900 μg - All Grades
5.5
Not reported
Not reported
Not reported
Not reported
900 μg - Grades 3/4
5.5
Not reported
Not reported
Not reported
Not reported
All Patients - All Grades
3.8
Not reported
Not reported
Not reported
Not reported
All Patients - Grades 3/4
3.8
Not reported
Not reported
Not reported
Not reported
Endocrine disorders
Analysis denominator · Participants
Group
Source count
600 µg Bid - All Grades
49
600 μg - Grades 3/4
49
900 μg - All Grades
55
900 μg - Grades 3/4
55
All Patients - All Grades
104
All Patients - Grades 3/4
104
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
600 µg Bid - All Grades
6.1
Not reported
Not reported
Not reported
Not reported
600 μg - Grades 3/4
6.1
Not reported
Not reported
Not reported
Not reported
900 μg - All Grades
0
Not reported
Not reported
Not reported
Not reported
900 μg - Grades 3/4
0
Not reported
Not reported
Not reported
Not reported
All Patients - All Grades
2.9
Not reported
Not reported
Not reported
Not reported
All Patients - Grades 3/4
2.9
Not reported
Not reported
Not reported
Not reported
Gen disorders,admin site conditions
Analysis denominator · Participants
Group
Source count
600 µg Bid - All Grades
49
600 μg - Grades 3/4
49
900 μg - All Grades
55
900 μg - Grades 3/4
55
All Patients - All Grades
104
All Patients - Grades 3/4
104
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
600 µg Bid - All Grades
4.1
Not reported
Not reported
Not reported
Not reported
600 μg - Grades 3/4
4.1
Not reported
Not reported
Not reported
Not reported
900 μg - All Grades
0
Not reported
Not reported
Not reported
Not reported
900 μg - Grades 3/4
0
Not reported
Not reported
Not reported
Not reported
All Patients - All Grades
1.9
Not reported
Not reported
Not reported
Not reported
All Patients - Grades 3/4
1.9
Not reported
Not reported
Not reported
Not reported
Ear and labyrinth disorders
Analysis denominator · Participants
Group
Source count
600 µg Bid - All Grades
49
600 μg - Grades 3/4
49
900 μg - All Grades
55
900 μg - Grades 3/4
55
All Patients - All Grades
104
All Patients - Grades 3/4
104
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
600 µg Bid - All Grades
2.0
Not reported
Not reported
Not reported
Not reported
600 μg - Grades 3/4
2.0
Not reported
Not reported
Not reported
Not reported
900 μg - All Grades
0
Not reported
Not reported
Not reported
Not reported
900 μg - Grades 3/4
0
Not reported
Not reported
Not reported
Not reported
All Patients - All Grades
1.0
Not reported
Not reported
Not reported
Not reported
All Patients - Grades 3/4
1.0
Not reported
Not reported
Not reported
Not reported
Infections and infestations
Analysis denominator · Participants
Group
Source count
600 µg Bid - All Grades
49
600 μg - Grades 3/4
49
900 μg - All Grades
55
900 μg - Grades 3/4
55
All Patients - All Grades
104
All Patients - Grades 3/4
104
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
600 µg Bid - All Grades
2.0
Not reported
Not reported
Not reported
Not reported
600 μg - Grades 3/4
2.0
Not reported
Not reported
Not reported
Not reported
900 μg - All Grades
0
Not reported
Not reported
Not reported
Not reported
900 μg - Grades 3/4
0
Not reported
Not reported
Not reported
Not reported
All Patients - All Grades
1.0
Not reported
Not reported
Not reported
Not reported
All Patients - Grades 3/4
1.0
Not reported
Not reported
Not reported
Not reported
Musculoskeletal and connective tissue disorders
Analysis denominator · Participants
Group
Source count
600 µg Bid - All Grades
49
600 μg - Grades 3/4
49
900 μg - All Grades
55
900 μg - Grades 3/4
55
All Patients - All Grades
104
All Patients - Grades 3/4
104
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
600 µg Bid - All Grades
2.0
Not reported
Not reported
Not reported
Not reported
600 μg - Grades 3/4
2.0
Not reported
Not reported
Not reported
Not reported
900 μg - All Grades
0
Not reported
Not reported
Not reported
Not reported
900 μg - Grades 3/4
0
Not reported
Not reported
Not reported
Not reported
All Patients - All Grades
1.0
Not reported
Not reported
Not reported
Not reported
All Patients - Grades 3/4
1.0
Not reported
Not reported
Not reported
Not reported
Neoplasms benign, malignant and unspecified
Analysis denominator · Participants
Group
Source count
600 µg Bid - All Grades
49
600 μg - Grades 3/4
49
900 μg - All Grades
55
900 μg - Grades 3/4
55
All Patients - All Grades
104
All Patients - Grades 3/4
104
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
600 µg Bid - All Grades
2.0
Not reported
Not reported
Not reported
Not reported
600 μg - Grades 3/4
2.0
Not reported
Not reported
Not reported
Not reported
900 μg - All Grades
0
Not reported
Not reported
Not reported
Not reported
900 μg - Grades 3/4
0
Not reported
Not reported
Not reported
Not reported
All Patients - All Grades
1.0
Not reported
Not reported
Not reported
Not reported
All Patients - Grades 3/4
1.0
Not reported
Not reported
Not reported
Not reported
Nervous system disorders
Analysis denominator · Participants
Group
Source count
600 µg Bid - All Grades
49
600 μg - Grades 3/4
49
900 μg - All Grades
55
900 μg - Grades 3/4
55
All Patients - All Grades
104
All Patients - Grades 3/4
104
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
600 µg Bid - All Grades
2.0
Not reported
Not reported
Not reported
Not reported
600 μg - Grades 3/4
2.0
Not reported
Not reported
Not reported
Not reported
900 μg - All Grades
0
Not reported
Not reported
Not reported
Not reported
900 μg - Grades 3/4
0
Not reported
Not reported
Not reported
Not reported
All Patients - All Grades
1.0
Not reported
Not reported
Not reported
Not reported
All Patients - Grades 3/4
1.0
Not reported
Not reported
Not reported
Not reported
Psychiatric disorders
Analysis denominator · Participants
Group
Source count
600 µg Bid - All Grades
49
600 μg - Grades 3/4
49
900 μg - All Grades
55
900 μg - Grades 3/4
55
All Patients - All Grades
104
All Patients - Grades 3/4
104
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
600 µg Bid - All Grades
0
Not reported
Not reported
Not reported
Not reported
600 μg - Grades 3/4
0
Not reported
Not reported
Not reported
Not reported
900 μg - All Grades
1.8
Not reported
Not reported
Not reported
Not reported
900 μg - Grades 3/4
1.8
Not reported
Not reported
Not reported
Not reported
All Patients - All Grades
1.0
Not reported
Not reported
Not reported
Not reported
All Patients - Grades 3/4
1.0
Not reported
Not reported
Not reported
Not reported
Respiratory, thoracic, mediastinal disorders
Analysis denominator · Participants
Group
Source count
600 µg Bid - All Grades
49
600 μg - Grades 3/4
49
900 μg - All Grades
55
900 μg - Grades 3/4
55
All Patients - All Grades
104
All Patients - Grades 3/4
104
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
600 µg Bid - All Grades
0
Not reported
Not reported
Not reported
Not reported
600 μg - Grades 3/4
0
Not reported
Not reported
Not reported
Not reported
900 μg - All Grades
1.8
Not reported
Not reported
Not reported
Not reported
900 μg - Grades 3/4
0
Not reported
Not reported
Not reported
Not reported
All Patients - All Grades
1.0
Not reported
Not reported
Not reported
Not reported
All Patients - Grades 3/4
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
53.1
group Id
OG001
value
53.1
group Id
OG002
value
29.1
group Id
OG003
value
27.3
group Id
OG004
value
40.4
group Id
OG005
value
39.4
denoms
counts
group Id
OG000
value
49
group Id
OG001
value
49
group Id
OG002
value
55
group Id
OG003
value
55
group Id
OG004
value
104
group Id
OG005
value
104
units
Participants
title
Any primary system organ class
categories
measurements
group Id
OG000
value
26.5
group Id
OG001
value
26.5
group Id
OG002
value
12.7
group Id
OG003
value
10.9
group Id
OG004
value
19.2
group Id
OG005
value
18.3
denoms
counts
group Id
OG000
value
49
group Id
OG001
value
26
group Id
OG002
value
55
group Id
OG003
value
55
group Id
OG004
value
104
group Id
OG005
value
104
units
Participants
title
Metabolism and nutrition disorders
categories
measurements
group Id
OG000
value
18.4
group Id
OG001
value
18.4
group Id
OG002
value
7.3
group Id
OG003
value
7.3
group Id
OG004
value
12.5
group Id
OG005
value
12.5
denoms
counts
group Id
OG000
value
49
group Id
OG001
value
49
group Id
OG002
value
55
group Id
OG003
value
55
group Id
OG004
value
104
group Id
OG005
value
104
units
Participants
title
Gastrointestinal disorders
categories
measurements
group Id
OG000
value
8.2
group Id
OG001
value
8.2
group Id
OG002
value
3.6
group Id
OG003
value
3.6
group Id
OG004
value
5.8
group Id
OG005
value
5.8
denoms
counts
group Id
OG000
value
49
group Id
OG001
value
49
group Id
OG002
value
55
group Id
OG003
value
55
group Id
OG004
value
104
group Id
OG005
value
104
units
Participants
title
Investigations
categories
measurements
group Id
OG000
value
2.0
group Id
OG001
value
2.0
group Id
OG002
value
5.5
group Id
OG003
value
5.5
group Id
OG004
value
3.8
group Id
OG005
value
3.8
denoms
counts
group Id
OG000
value
49
group Id
OG001
value
49
group Id
OG002
value
55
group Id
OG003
value
55
group Id
OG004
value
104
group Id
OG005
value
104
units
Participants
title
Hepatobiliary disorders
categories
measurements
group Id
OG000
value
6.1
group Id
OG001
value
6.1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
2.9
group Id
OG005
value
2.9
denoms
counts
group Id
OG000
value
49
group Id
OG001
value
49
group Id
OG002
value
55
group Id
OG003
value
55
group Id
OG004
value
104
group Id
OG005
value
104
units
Participants
title
Endocrine disorders
categories
measurements
group Id
OG000
value
4.1
group Id
OG001
value
4.1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1.9
group Id
OG005
value
1.9
denoms
counts
group Id
OG000
value
49
group Id
OG001
value
49
group Id
OG002
value
55
group Id
OG003
value
55
group Id
OG004
value
104
group Id
OG005
value
104
units
Participants
title
Gen disorders,admin site conditions
categories
measurements
group Id
OG000
value
2.0
group Id
OG001
value
2.0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1.0
group Id
OG005
value
1.0
denoms
counts
group Id
OG000
value
49
group Id
OG001
value
49
group Id
OG002
value
55
group Id
OG003
value
55
group Id
OG004
value
104
group Id
OG005
value
104
units
Participants
title
Ear and labyrinth disorders
categories
measurements
group Id
OG000
value
2.0
group Id
OG001
value
2.0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1.0
group Id
OG005
value
1.0
denoms
counts
group Id
OG000
value
49
group Id
OG001
value
49
group Id
OG002
value
55
group Id
OG003
value
55
group Id
OG004
value
104
group Id
OG005
value
104
units
Participants
title
Infections and infestations
categories
measurements
group Id
OG000
value
2.0
group Id
OG001
value
2.0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1.0
group Id
OG005
value
1.0
denoms
counts
group Id
OG000
value
49
group Id
OG001
value
49
group Id
OG002
value
55
group Id
OG003
value
55
group Id
OG004
value
104
group Id
OG005
value
104
units
Participants
title
Musculoskeletal and connective tissue disorders
categories
measurements
group Id
OG000
value
2.0
group Id
OG001
value
2.0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1.0
group Id
OG005
value
1.0
denoms
counts
group Id
OG000
value
49
group Id
OG001
value
49
group Id
OG002
value
55
group Id
OG003
value
55
group Id
OG004
value
104
group Id
OG005
value
104
units
Participants
title
Neoplasms benign, malignant and unspecified
categories
measurements
group Id
OG000
value
2.0
group Id
OG001
value
2.0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1.0
group Id
OG005
value
1.0
denoms
counts
group Id
OG000
value
49
group Id
OG001
value
49
group Id
OG002
value
55
group Id
OG003
value
55
group Id
OG004
value
104
group Id
OG005
value
104
units
Participants
title
Nervous system disorders
denoms
counts
group Id
OG000
value
49
group Id
OG001
value
49
group Id
OG002
value
55
group Id
OG003
value
55
group Id
OG004
value
104
group Id
OG005
value
104
units
Participants
description
Only AEs occurring on or after the start of study treatment and no more than 28 days after the discontinuation of study treatment. A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple severity grades for an AE while on a treatment, is only counted under the maximum grade.
groups
description
All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.
id
OG000
title
600 µg Bid - All Grades
description
Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients
id
OG001
title
600 μg - Grades 3/4
description
All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
id
OG002
title
900 μg - All Grades
description
Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg
id
OG003
title
900 μg - Grades 3/4
description
All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
id
OG004
title
All Patients - All Grades
description
All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
id
OG005
title
All Patients - Grades 3/4
param Type
NUMBER
population Description
Three additional arms were created to display subset of subjects with specific criteria.
reporting Status
POSTED
time Frame
Baseline up to approximately 256 weeks
title
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE)
Triangle