TriangleNCT01582061 · OUTCOME
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Muscle Strength
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
Direct observation of ability to stand unaided: 0=able to stand easily with arms extended, 1=able to stand after several efforts without using arms as assistance, 2=able to stand only by using arms as assistance 3=completely unable to stand
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 | 13 |
| Pasireotide 900 μg | 9 |
| All Patients | 22 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | -34.6 | 62.53 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | -53.7 | 46.98 | Not reported | Not reported | Not reported |
| All Patients | -42.4 | 56.28 | Not reported | Not reported | Not reported |
Week 24
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 7 |
| Pasireotide 900 μg | 7 |
| All Patients | 14 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | -28.6 | 48.80 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | -47.6 | 50.40 | Not reported | Not reported | Not reported |
| All Patients | -38.1 | 48.67 | Not reported | Not reported | Not reported |
Week 48
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 5 |
| Pasireotide 900 μg | 4 |
| All Patients | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | -30.0 | 44.72 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | -75.0 | 50.0 | Not reported | Not reported | Not reported |
| All Patients | -50.0 | 50.00 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 62.53
- value
- -34.6
- group Id
- OG001
- spread
- 46.98
- value
- -53.7
- group Id
- OG002
- spread
- 56.28
- value
- -42.4
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 48.80
- value
- -28.6
- group Id
- OG001
- spread
- 50.40
- value
- -47.6
- group Id
- OG002
- spread
- 48.67
- value
- -38.1
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 14
- units
- Participants
- title
- Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 44.72
- value
- -30.0
- group Id
- OG001
- spread
- 50.0
- value
- -75.0
- group Id
- OG002
- spread
- 50.00
- value
- -50.0
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 9
- 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
- Direct observation of ability to stand unaided: 0=able to stand easily with arms extended, 1=able to stand after several efforts without using arms as assistance, 2=able to stand only by using arms as assistance 3=completely unable to stand
- 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 - Muscle Strength
- type
- SECONDARY
- unit Of Measure
- percent change in scores
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice