TriangleNCT01582061 · OUTCOME
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Waist Circumference
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent change of centimeters
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, week 12, 24 and 48
What was measured
Clinically relevant threshold (at any time point). Reduction of ≥ 5%, Reduction of ≥ 10%
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 | 42 |
| All Patients | 77 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | -2.0 | 4.29 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | -2.9 | 6.70 | Not reported | Not reported | Not reported |
| All Patients | -2.5 | 5.72 | Not reported | Not reported | Not reported |
Week 24
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 24 |
| Pasireotide 900 μg | 28 |
| All Patients | 52 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | -5.8 | 6.28 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | -3.1 | 5.48 | Not reported | Not reported | Not reported |
| All Patients | -4.4 | 5.96 | Not reported | Not reported | Not reported |
Week 48
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 16 |
| Pasireotide 900 μg | 20 |
| All Patients | 36 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | -5.1 | 5.74 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | -4.1 | 5.64 | Not reported | Not reported | Not reported |
| All Patients | -4.6 | 5.62 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 4.29
- value
- -2.0
- group Id
- OG001
- spread
- 6.70
- value
- -2.9
- group Id
- OG002
- spread
- 5.72
- value
- -2.5
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 42
- group Id
- OG002
- value
- 77
- units
- Participants
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 6.28
- value
- -5.8
- group Id
- OG001
- spread
- 5.48
- value
- -3.1
- group Id
- OG002
- spread
- 5.96
- value
- -4.4
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 52
- units
- Participants
- title
- Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 5.74
- value
- -5.1
- group Id
- OG001
- spread
- 5.64
- value
- -4.1
- group Id
- OG002
- spread
- 5.62
- value
- -4.6
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 36
- 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
- Clinically relevant threshold (at any time point). Reduction of ≥ 5%, Reduction of ≥ 10%
- 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 - Waist Circumference
- type
- SECONDARY
- unit Of Measure
- percent change of centimeters
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice