NCT01582061 · OUTCOME
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP)
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
- MEAN
- Unit
- percent change of mmhg
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, week 12, 24 and 48
What was measured
Standing systolic and diastolic BP based on 1 assessment and sitting systolic and diastolic BP was mean of 3 assessments.
Analysis population: Number of patients with available data differed at visits
Groups in this outcome
Pasireotide 600 μg
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.
Pasireotide 900 μg
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
All Patients
Patients received pasireotide 600 μg or 900 μg BID
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 |
|---|
| Pasireotide 600 μg | 49 |
|---|
| Pasireotide 900 μg | 55 |
|---|
| All Patients | 104 |
|---|
Reported measurements
Sitting systolic Week 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 35 |
|---|
| Pasireotide 900 μg | 45 |
|---|
| All Patients | 80 |
|---|
Values in percent change of mmhg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | -6.8 | 12.04 | Not reported | Not reported | Not reported |
|---|
| Pasireotide 900 μg | -1.4 | 14.40 | Not reported | Not reported | Not reported |
|---|
| All Patients | -3.8 | 13.61 | Not reported | Not reported | Not reported |
|---|
Sitting systolic Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 24 |
|---|
| Pasireotide 900 μg | 29 |
|---|
| All Patients | 53 |
|---|
Values in percent change of mmhg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | -7.4 | 8.97 | Not reported | Not reported | Not reported |
|---|
| Pasireotide 900 μg | -5.7 | 11.09 | Not reported | Not reported | Not reported |
|---|
| All Patients | -6.5 | 10.13 | Not reported | Not reported | Not reported |
|---|
Sitting systolic Week 48
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 16 |
|---|
| Pasireotide 900 μg | 21 |
|---|
| All Patients | 37 |
|---|
Values in percent change of mmhg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | -5.1 | 8.57 | Not reported | Not reported | Not reported |
|---|
| Pasireotide 900 μg | -4.7 | 12.55 | Not reported | Not reported | Not reported |
|---|
| All Patients | -4.9 | 10.87 | Not reported | Not reported | Not reported |
|---|
Standing systolic Week 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 34 |
|---|
| Pasireotide 900 μg | 44 |
|---|
| All Patients | 78 |
|---|
Values in percent change of mmhg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | -7.9 | 12.49 | Not reported | Not reported | Not reported |
|---|
| Pasireotide 900 μg | -3.6 | 15.38 | Not reported | Not reported | Not reported |
|---|
| All Patients | -5.5 | 14.27 | Not reported | Not reported | Not reported |
|---|
Standing systolic Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 23 |
|---|
| Pasireotide 900 μg | 29 |
|---|
| All Patients | 52 |
|---|
Values in percent change of mmhg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | -10.9 | 10.30 | Not reported | Not reported | Not reported |
|---|
| Pasireotide 900 μg | -6.7 | 14.09 | Not reported | Not reported | Not reported |
|---|
| All Patients | -8.6 | 12.62 | Not reported | Not reported | Not reported |
|---|
Standing systolic Week 48
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 15 |
|---|
| Pasireotide 900 μg | 21 |
|---|
| All Patients | 36 |
|---|
Values in percent change of mmhg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | -6.5 | 9.45 | Not reported | Not reported | Not reported |
|---|
| Pasireotide 900 μg | -4.4 | 13.86 | Not reported | Not reported | Not reported |
|---|
| All Patients | -5.3 | 12.10 | Not reported | Not reported | Not reported |
|---|
Sitting diastolic Week 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 35 |
|---|
| Pasireotide 900 μg | 45 |
|---|
| All Patients | 80 |
|---|
Values in percent change of mmhg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | -4.6 | 15.13 | Not reported | Not reported | Not reported |
|---|
| Pasireotide 900 μg | -0.2 | 14.40 | Not reported | Not reported | Not reported |
|---|
| All Patients | -2.1 | 14.79 | Not reported | Not reported | Not reported |
|---|
Sitting diastolic Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 24 |
|---|
| Pasireotide 900 μg | 29 |
|---|
| All Patients | 53 |
|---|
Values in percent change of mmhg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | -6.2 | 7.29 | Not reported | Not reported | Not reported |
|---|
| Pasireotide 900 μg | -3.8 | 15.83 | Not reported | Not reported | Not reported |
|---|
| All Patients | -4.9 | 12.65 | Not reported | Not reported | Not reported |
|---|
Sitting diastolic Week 48
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 16 |
|---|
| Pasireotide 900 μg | 21 |
|---|
| All Patients | 37 |
|---|
Values in percent change of mmhg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | -3.3 | 10.38 | Not reported | Not reported | Not reported |
|---|
| Pasireotide 900 μg | -4.3 | 13.93 | Not reported | Not reported | Not reported |
|---|
| All Patients | -3.8 | 12.37 | Not reported | Not reported | Not reported |
|---|
Standing diastolic Week 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 34 |
|---|
| Pasireotide 900 μg | 44 |
|---|
| All Patients | 78 |
|---|
Values in percent change of mmhg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | -5.5 | 16.02 | Not reported | Not reported | Not reported |
|---|
| Pasireotide 900 μg | -1.9 | 17.63 | Not reported | Not reported | Not reported |
|---|
| All Patients | -3.5 | 16.93 | Not reported | Not reported | Not reported |
|---|
Standing diastolic Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 23 |
|---|
| Pasireotide 900 μg | 29 |
|---|
| All Patients | 52 |
|---|
Values in percent change of mmhg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | -7.6 | 10.30 | Not reported | Not reported | Not reported |
|---|
| Pasireotide 900 μg | -5.3 | 16.74 | Not reported | Not reported | Not reported |
|---|
| All Patients | -6.3 | 14.18 | Not reported | Not reported | Not reported |
|---|
Standing diastolic Week 48
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 15 |
|---|
| Pasireotide 900 μg | 21 |
|---|
| All Patients | 36 |
|---|
Values in percent change of mmhg · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | -2.1 | 13.78 | Not reported | Not reported | Not reported |
|---|
| Pasireotide 900 μg | -4.4 | 14.13 | Not reported | Not reported | Not reported |
|---|
| All Patients | -3.4 | 13.83 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 12.04
- value
- -6.8
- group Id
- OG001
- spread
- 14.40
- value
- -1.4
- group Id
- OG002
- spread
- 13.61
- value
- -3.8
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 45
- group Id
- OG002
- value
- 80
- units
- Participants
- title
- Sitting systolic Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 8.97
- value
- -7.4
- group Id
- OG001
- spread
- 11.09
- value
- -5.7
- group Id
- OG002
- spread
- 10.13
- value
- -6.5
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 53
- units
- Participants
- title
- Sitting systolic Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 8.57
- value
- -5.1
- group Id
- OG001
- spread
- 12.55
- value
- -4.7
- group Id
- OG002
- spread
- 10.87
- value
- -4.9
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 37
- units
- Participants
- title
- Sitting systolic Week 48
- categories
- measurements
- group Id
- OG000
- spread
- 12.49
- value
- -7.9
- group Id
- OG001
- spread
- 15.38
- value
- -3.6
- group Id
- OG002
- spread
- 14.27
- value
- -5.5
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 78
- units
- Participants
- title
- Standing systolic Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 10.30
- value
- -10.9
- group Id
- OG001
- spread
- 14.09
- value
- -6.7
- group Id
- OG002
- spread
- 12.62
- value
- -8.6
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 52
- units
- Participants
- title
- Standing systolic Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 9.45
- value
- -6.5
- group Id
- OG001
- spread
- 13.86
- value
- -4.4
- group Id
- OG002
- spread
- 12.10
- value
- -5.3
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 36
- units
- Participants
- title
- Standing systolic Week 48
- categories
- measurements
- group Id
- OG000
- spread
- 15.13
- value
- -4.6
- group Id
- OG001
- spread
- 14.40
- value
- -0.2
- group Id
- OG002
- spread
- 14.79
- value
- -2.1
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 45
- group Id
- OG002
- value
- 80
- units
- Participants
- title
- Sitting diastolic Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 7.29
- value
- -6.2
- group Id
- OG001
- spread
- 15.83
- value
- -3.8
- group Id
- OG002
- spread
- 12.65
- value
- -4.9
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 53
- units
- Participants
- title
- Sitting diastolic Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 10.38
- value
- -3.3
- group Id
- OG001
- spread
- 13.93
- value
- -4.3
- group Id
- OG002
- spread
- 12.37
- value
- -3.8
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 37
- units
- Participants
- title
- Sitting diastolic Week 48
- categories
- measurements
- group Id
- OG000
- spread
- 16.02
- value
- -5.5
- group Id
- OG001
- spread
- 17.63
- value
- -1.9
- group Id
- OG002
- spread
- 16.93
- value
- -3.5
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 78
- units
- Participants
- title
- Standing diastolic Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 10.30
- value
- -7.6
- group Id
- OG001
- spread
- 16.74
- value
- -5.3
- group Id
- OG002
- spread
- 14.18
- value
- -6.3
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 52
- units
- Participants
- title
- Standing diastolic Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 13.78
- value
- -2.1
- group Id
- OG001
- spread
- 14.13
- value
- -4.4
- group Id
- OG002
- spread
- 13.83
- value
- -3.4
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 36
- units
- Participants
- title
- Standing diastolic Week 48
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 55
- group Id
- OG002
- value
- 104
- units
- Participants
- description
- Standing systolic and diastolic BP based on 1 assessment and sitting systolic and diastolic BP was mean of 3 assessments.
- dispersion Type
- Standard Deviation
- groups
- description
- 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
- Pasireotide 600 μg
- description
- 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
- OG001
- title
- Pasireotide 900 μg
- description
- Patients received pasireotide 600 μg or 900 μg BID
- id
- OG002
- title
- All Patients
- param Type
- MEAN
- population Description
- Number of patients with available data differed at visits
- reporting Status
- POSTED
- time Frame
- Baseline, week 12, 24 and 48
- title
- Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP)
- type
- SECONDARY
- unit Of Measure
- percent change of mmhg
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