TriangleNCT01582061 · OUTCOME
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Hirsutism
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent change in scores
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, week 12, 24 and 48
What was measured
Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)\*100. Ferriman-Gallway scoring was used: 0=minimum and 36 was maximum in females only.
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 | 37 |
| Pasireotide 900 μg | 47 |
| All Patients | 84 |
Reported measurements
Week 12
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 24 |
| Pasireotide 900 μg | 31 |
| All Patients | 55 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | -12.2 | 24.57 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | -8.2 | 35.30 | Not reported | Not reported | Not reported |
| All Patients | -10.0 | 30.88 | Not reported | Not reported | Not reported |
Week 24
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 16 |
| Pasireotide 900 μg | 20 |
| All Patients | 36 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | -21.2 | 32.72 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | -16.2 | 46.99 | Not reported | Not reported | Not reported |
| All Patients | 18.4 | 40.79 | Not reported | Not reported | Not reported |
Week 48
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 11 |
| Pasireotide 900 μg | 15 |
| All Patients | 26 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | -18.2 | 30.12 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | 9.6 | 143.83 | Not reported | Not reported | Not reported |
| All Patients | -2.2 | 110.20 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 24.57
- value
- -12.2
- group Id
- OG001
- spread
- 35.30
- value
- -8.2
- group Id
- OG002
- spread
- 30.88
- value
- -10.0
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 55
- units
- Participants
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 32.72
- value
- -21.2
- group Id
- OG001
- spread
- 46.99
- value
- -16.2
- group Id
- OG002
- spread
- 40.79
- value
- 18.4
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 36
- units
- Participants
- title
- Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 30.12
- value
- -18.2
- group Id
- OG001
- spread
- 143.83
- value
- 9.6
- group Id
- OG002
- spread
- 110.20
- value
- -2.2
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 26
- units
- Participants
- title
- Week 48
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 47
- group Id
- OG002
- value
- 84
- units
- Participants
- description
- Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)\*100. Ferriman-Gallway scoring was used: 0=minimum and 36 was maximum in females only.
- 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 - Hirsutism
- type
- SECONDARY
- unit Of Measure
- percent change in scores
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice