TriangleNCT01137682 · OUTCOME
Duration of the First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- CORE baseline up to approximately 268 weeks
What was measured
n is the number of patients achieving response criteria. The weeks correspond to duration of first response (in weeks) for patients achieving biomedical control. Median and 95% CI are derived from Kaplan-Meier curves. Kaplan-Meier estimates \[95% CI\] at each time point are estimates of probability of response.
Groups in this outcome
Pasireotide LAR 40 mg Extension
If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
Pasireotide LAR 60 mg Extension
If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
Cross Over to Pasireotide Extension
Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
| Group | Source count |
|---|---|
| Pasireotide LAR 40 mg Extension | 57 |
| Pasireotide LAR 60 mg Extension | 54 |
| Cross Over to Pasireotide Extension | 62 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide LAR 40 mg Extension | 29.1 | Not reported | 15.6 | 48.1 | Not reported |
| Pasireotide LAR 60 mg Extension | 26.9 | Not reported | 12.7 | 48.0 | Not reported |
| Cross Over to Pasireotide Extension | 24.9 | Not reported | 12.4 | 47.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.6
- upper Limit
- 48.1
- value
- 29.1
- group Id
- OG001
- lower Limit
- 12.7
- upper Limit
- 48.0
- value
- 26.9
- group Id
- OG002
- lower Limit
- 12.4
- upper Limit
- 47.4
- value
- 24.9
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 54
- group Id
- OG002
- value
- 62
- units
- Participants
- description
- n is the number of patients achieving response criteria. The weeks correspond to duration of first response (in weeks) for patients achieving biomedical control. Median and 95% CI are derived from Kaplan-Meier curves. Kaplan-Meier estimates \[95% CI\] at each time point are estimates of probability of response.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
- id
- OG000
- title
- Pasireotide LAR 40 mg Extension
- description
- If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
- id
- OG001
- title
- Pasireotide LAR 60 mg Extension
- description
- Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
- id
- OG002
- title
- Cross Over to Pasireotide Extension
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- CORE baseline up to approximately 268 weeks
- title
- Duration of the First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice