TriangleNCT01582061 · OUTCOME
Percent Change From Baseline in Growth Hormone (GH) Values
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent change of µg/L
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, week 12, 24 and 48
What was measured
Descriptive summary of the effect of pasireotide on GH.
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 | 48 |
| Pasireotide 900 μg | 55 |
| All Patients | 103 |
Reported measurements
Week 12
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 35 |
| Pasireotide 900 μg | 45 |
| All Patients | 80 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | -17.3 | 109.89 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | -20.90 | 156.60 | Not reported | Not reported | Not reported |
| All Patients | -19.3 | 137.33 | Not reported | Not reported | Not reported |
Week 24
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 22 |
| Pasireotide 900 μg | 29 |
| All Patients | 51 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | -22.2 | 62.43 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | -26.2 | 105.44 | Not reported | Not reported | Not reported |
| All Patients | -24.4 | 88.70 | 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 | 23.1 | 127.30 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | -1.0 | 134.97 | Not reported | Not reported | Not reported |
| All Patients | 9.7 | 130.32 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 109.89
- value
- -17.3
- group Id
- OG001
- spread
- 156.60
- value
- -20.90
- group Id
- OG002
- spread
- 137.33
- value
- -19.3
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 45
- group Id
- OG002
- value
- 80
- units
- Participants
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 62.43
- value
- -22.2
- group Id
- OG001
- spread
- 105.44
- value
- -26.2
- group Id
- OG002
- spread
- 88.70
- value
- -24.4
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 51
- units
- Participants
- title
- Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 127.30
- value
- 23.1
- group Id
- OG001
- spread
- 134.97
- value
- -1.0
- group Id
- OG002
- spread
- 130.32
- value
- 9.7
- 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
- 48
- group Id
- OG001
- value
- 55
- group Id
- OG002
- value
- 103
- units
- Participants
- description
- Descriptive summary of the effect of pasireotide on GH.
- 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 From Baseline in Growth Hormone (GH) Values
- type
- SECONDARY
- unit Of Measure
- percent change of µg/L
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice