TriangleNCT01137682 · OUTCOME
Time to First Response (Weeks) by Treatment 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
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
Time to first response is defined as the time from the date of first dose to the date of first occurrence of a reduction of mean GH \< 2.5 µg/L and the normalization of IGF-1. The weeks correspond to time taken to achieve first mean GH \< 2.5 µg/L and the normalization of IGF-1.
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 | 112.3 | Not reported | 76.1 | 254.1 | Not reported |
| Pasireotide LAR 60 mg Extension | 65.3 | Not reported | 40.4 | 94.9 | Not reported |
| Cross Over to Pasireotide Extension | 95.1 | Not reported | 65.3 | 156.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 76.1
- upper Limit
- 254.1
- value
- 112.3
- group Id
- OG001
- lower Limit
- 40.4
- upper Limit
- 94.9
- value
- 65.3
- group Id
- OG002
- lower Limit
- 65.3
- upper Limit
- 156.0
- value
- 95.1
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 54
- group Id
- OG002
- value
- 62
- units
- Participants
- description
- Time to first response is defined as the time from the date of first dose to the date of first occurrence of a reduction of mean GH \< 2.5 µg/L and the normalization of IGF-1. The weeks correspond to time taken to achieve first mean GH \< 2.5 µg/L and the normalization of IGF-1.
- 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
- Time to First Response (Weeks) by Treatment 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
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice