TriangleNCT01582061 · OUTCOME
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Body Mass Index (BMI)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent change in kg/m2
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, week 12, 24 and 48
What was measured
Percent change in patients reducing by at least one class level. Class levels: \<25.0, 25.0 to \<30.0, ≥ 30.0. Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)\*100
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 | Source count |
|---|---|
| Pasireotide 600 μg | 49 |
| Pasireotide 900 μg | 55 |
| All Patients | 104 |
Reported measurements
Week 12
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 35 |
| Pasireotide 900 μg | 44 |
| All Patients | 79 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | -4.2 | 3.70 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | -4.8 | 5.38 | Not reported | Not reported | Not reported |
| All Patients | -4.5 | 4.69 | Not reported | Not reported | Not reported |
Week 24
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 24 |
| Pasireotide 900 μg | 29 |
| All Patients | 53 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | -7.3 | 5.46 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | -5.2 | 6.51 | Not reported | Not reported | Not reported |
| All Patients | -6.1 | 6.10 | Not reported | Not reported | Not reported |
Week 48
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 16 |
| Pasireotide 900 μg | 21 |
| All Patients | 37 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | -8.0 | 6.82 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | -6.3 | 7.88 | Not reported | Not reported | Not reported |
| All Patients | -7.0 | 7.39 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.70
- value
- -4.2
- group Id
- OG001
- spread
- 5.38
- value
- -4.8
- group Id
- OG002
- spread
- 4.69
- value
- -4.5
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 79
- units
- Participants
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 5.46
- value
- -7.3
- group Id
- OG001
- spread
- 6.51
- value
- -5.2
- group Id
- OG002
- spread
- 6.10
- value
- -6.1
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 53
- units
- Participants
- title
- Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 6.82
- value
- -8.0
- group Id
- OG001
- spread
- 7.88
- value
- -6.3
- group Id
- OG002
- spread
- 7.39
- value
- -7.0
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 37
- units
- Participants
- title
- Week 48
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 55
- group Id
- OG002
- value
- 104
- units
- Participants
- description
- Percent change in patients reducing by at least one class level. Class levels: \<25.0, 25.0 to \<30.0, ≥ 30.0. Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)\*100
- 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 - Body Mass Index (BMI)
- type
- SECONDARY
- unit Of Measure
- percent change in kg/m2
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice