NCT02354508 · OUTCOME
Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Week 36
What was measured
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, by previous treatment and overall - last observation carried forward (LOCF)
Analysis population: Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.
Groups in this outcome
Lanreotide 120 mg
Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
Octreotide 30 mg
Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
Octreotide 40 mg
Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).
Pasireotide LAR Overall
This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
| Group | Source count |
|---|---|
| Lanreotide 120 mg | 41 |
| Octreotide 30 mg | 29 |
| Octreotide 40 mg | 53 |
| Pasireotide LAR Overall | 123 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lanreotide 120 mg | 14.6 | Not reported | 5.57 | 29.17 | Not reported |
| Octreotide 30 mg | 13.8 | Not reported | 3.89 | 31.66 | Not reported |
| Octreotide 40 mg | 17.0 | Not reported | 8.07 | 29.80 | Not reported |
| Pasireotide LAR Overall | 15.4 | Not reported | 9.56 | 23.07 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.57
- upper Limit
- 29.17
- value
- 14.6
- group Id
- OG001
- lower Limit
- 3.89
- upper Limit
- 31.66
- value
- 13.8
- group Id
- OG002
- lower Limit
- 8.07
- upper Limit
- 29.80
- value
- 17.0
- group Id
- OG003
- lower Limit
- 9.56
- upper Limit
- 23.07
- value
- 15.4
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 53
- group Id
- OG003
- value
- 123
- units
- Participants
- description
- Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, by previous treatment and overall - last observation carried forward (LOCF)
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
- id
- OG000
- title
- Lanreotide 120 mg
- description
- Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
- id
- OG001
- title
- Octreotide 30 mg
- description
- Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).
- id
- OG002
- title
- Octreotide 40 mg
- description
- This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
- id
- OG003
- title
- Pasireotide LAR Overall
- param Type
- NUMBER
- population Description
- Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.
- reporting Status
- POSTED
- time Frame
- Week 36
- title
- Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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