TriangleNCT01582061 · OUTCOME
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent change in celius
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline week 12, 24 and 48
What was measured
degrees celius
Analysis population: Number of patients with available data differed at visits
Groups in this outcome
600 µg Bid - All Grades
All grades of adverse events. 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.
900 μg - All Grades
All grades of adverse events. 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 - All Grades
All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
| Group | Source count |
|---|---|
| 600 µg Bid - All Grades | 49 |
| 900 μg - All Grades | 55 |
| All Patients - All Grades | 104 |
Reported measurements
Week 12
| Group | Source count |
|---|---|
| 600 µg Bid - All Grades | 33 |
| 900 μg - All Grades | 43 |
| All Patients - All Grades | 76 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 600 µg Bid - All Grades | 0.1 | 1.26 | Not reported | Not reported | Not reported |
| 900 μg - All Grades | -0.3 | 1.06 | Not reported | Not reported | Not reported |
| All Patients - All Grades | -0.1 | 1.17 | Not reported | Not reported | Not reported |
Week 24
| Group | Source count |
|---|---|
| 600 µg Bid - All Grades | 21 |
| 900 μg - All Grades | 28 |
| All Patients - All Grades | 49 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 600 µg Bid - All Grades | -0.1 | 1.15 | Not reported | Not reported | Not reported |
| 900 μg - All Grades | -0.1 | 1.26 | Not reported | Not reported | Not reported |
| All Patients - All Grades | -0.1 | 1.20 | Not reported | Not reported | Not reported |
Week 48
| Group | Source count |
|---|---|
| 600 µg Bid - All Grades | 15 |
| 900 μg - All Grades | 20 |
| All Patients - All Grades | 35 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 600 µg Bid - All Grades | 0.03 | 1.47 | Not reported | Not reported | Not reported |
| 900 μg - All Grades | -0.1 | 1.19 | Not reported | Not reported | Not reported |
| All Patients - All Grades | 0.1 | 1.31 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.26
- value
- 0.1
- group Id
- OG001
- spread
- 1.06
- value
- -0.3
- group Id
- OG002
- spread
- 1.17
- value
- -0.1
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 43
- group Id
- OG002
- value
- 76
- units
- Participants
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 1.15
- value
- -0.1
- group Id
- OG001
- spread
- 1.26
- value
- -0.1
- group Id
- OG002
- spread
- 1.20
- value
- -0.1
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 49
- units
- Participants
- title
- Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 1.47
- value
- 0.03
- group Id
- OG001
- spread
- 1.19
- value
- -0.1
- group Id
- OG002
- spread
- 1.31
- value
- 0.1
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 35
- 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
- degrees celius
- dispersion Type
- Standard Deviation
- groups
- description
- All grades of adverse events. 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
- 600 µg Bid - All Grades
- description
- All grades of adverse events. 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
- 900 μg - All Grades
- description
- All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
- id
- OG002
- title
- All Patients - All Grades
- 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 - Temperature
- type
- SECONDARY
- unit Of Measure
- percent change in celius
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice