NCT01673646 · OUTCOME
Change in Mean GH Levels From Baseline
Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism · Source last updated 2019-09-16
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- ug/L
- Interval / dispersion
- Full Range
- Time frame
- Baseline, Months 2.75, 3, 6, 9, 12, 18, 24
What was measured
This shows the change in mean GH levels from baseline in median GH levels by visit.
Analysis population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. Protocol allowed to change treatment dose (eg, 20mg -\> 40mg -\>20mg -\> 40mg -\>60mg) based on efficacy and safety after 3month treatment. So we combined Arms/groups.
Groups in this outcome
Pasireotide LAR - All Participants
All patients randomized regardless of pasireotide LAR dose.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide LAR - All Participants | 33 |
|---|
Reported measurements
Change from baseline @ Month 2.75
Values in ug/L · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR - All Participants | -7.60 | Not reported | -157.2 | 39.3 | Not reported |
|---|
Change from baseline @ Month 3
Values in ug/L · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR - All Participants | -5.98 | Not reported | -99.2 | 39.3 | Not reported |
|---|
Change from baseline @ Month 6
Values in ug/L · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR - All Participants | -7.27 | Not reported | -149.8 | 39.3 | Not reported |
|---|
Change from baseline @ Month 9
Values in ug/L · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR - All Participants | -8.83 | Not reported | -163.8 | 39.3 | Not reported |
|---|
Change from baseline @ Month 12
Values in ug/L · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR - All Participants | -8.90 | Not reported | -159.2 | 3.0 | Not reported |
|---|
Change from baseline @ Month 18
Values in ug/L · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR - All Participants | -15.68 | Not reported | -23.9 | 39.3 | Not reported |
|---|
Change from baseline @ Month 24
Values in ug/L · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR - All Participants | -16.67 | Not reported | -25.5 | -1.4 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -157.2
- upper Limit
- 39.3
- value
- -7.60
- title
- Change from baseline @ Month 2.75
- categories
- measurements
- group Id
- OG000
- lower Limit
- -99.2
- upper Limit
- 39.3
- value
- -5.98
- title
- Change from baseline @ Month 3
- categories
- measurements
- group Id
- OG000
- lower Limit
- -149.8
- upper Limit
- 39.3
- value
- -7.27
- title
- Change from baseline @ Month 6
- categories
- measurements
- group Id
- OG000
- lower Limit
- -163.8
- upper Limit
- 39.3
- value
- -8.83
- title
- Change from baseline @ Month 9
- categories
- measurements
- group Id
- OG000
- lower Limit
- -159.2
- upper Limit
- 3.0
- value
- -8.90
- title
- Change from baseline @ Month 12
- categories
- measurements
- group Id
- OG000
- lower Limit
- -23.9
- upper Limit
- 39.3
- value
- -15.68
- title
- Change from baseline @ Month 18
- categories
- measurements
- group Id
- OG000
- lower Limit
- -25.5
- upper Limit
- -1.4
- value
- -16.67
- title
- Change from baseline @ Month 24
- description
- This shows the change in mean GH levels from baseline in median GH levels by visit.
- dispersion Type
- Full Range
- groups
- description
- All patients randomized regardless of pasireotide LAR dose.
- id
- OG000
- title
- Pasireotide LAR - All Participants
- param Type
- MEDIAN
- population Description
- FAS: Comprises all patients to whom study treatment has been assigned by randomization. Protocol allowed to change treatment dose (eg, 20mg -\> 40mg -\>20mg -\> 40mg -\>60mg) based on efficacy and safety after 3month treatment. So we combined Arms/groups.
- reporting Status
- POSTED
- time Frame
- Baseline, Months 2.75, 3, 6, 9, 12, 18, 24
- title
- Change in Mean GH Levels From Baseline
- type
- SECONDARY
- unit Of Measure
- ug/L
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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