NCT01137682 · OUTCOME
Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set)
Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly · Source last updated 2018-04-05
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Extension baseline up to approximately 196 weeks
What was measured
PK samples were collected for those patients treated with pasireotide LAR in the core study and who continued on pasireotide LAR in the extension phase. PK samples were collected before the injection of pasireotide LAR only at weeks 112 and 196. PK samples were also collected at weeks 48 and 132 only for all patients treated with octreotide LAR 30 mg or lanreotide ATG 120 mg in the core study who started treatment with pasireotide LAR in the extension study.
Blood samples (2.5 mL each sample) were collected to yield 1-mL plasma for analysis of pasireotide LAR oncentration.
Analysis population: Available data for analysis varies at visits
Groups in this outcome
Pasireotide LAR 40 mg
Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
Pasireotide LAR 60 mg
Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
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 40 mg | 116 |
|---|
| Pasireotide LAR 60 mg | 93 |
|---|
Reported measurements
Week 48
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide LAR 40 mg | 51 |
|---|
| Pasireotide LAR 60 mg | 0 |
|---|
Values in mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR 40 mg | 5.70 | 3.159 | Not reported | Not reported | Not reported |
|---|
Week 112
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide LAR 40 mg | 25 |
|---|
| Pasireotide LAR 60 mg | 72 |
|---|
Values in mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR 40 mg | 8.66 | 4.154 | Not reported | Not reported | Not reported |
|---|
| Pasireotide LAR 60 mg | 14.06 | 9.807 | Not reported | Not reported | Not reported |
|---|
Week 132
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide LAR 40 mg | 35 |
|---|
| Pasireotide LAR 60 mg | 0 |
|---|
Values in mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR 40 mg | 9.28 | 5.067 | Not reported | Not reported | Not reported |
|---|
Week 196
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide LAR 40 mg | 21 |
|---|
| Pasireotide LAR 60 mg | 65 |
|---|
Values in mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR 40 mg | 10.32 | 5.473 | Not reported | Not reported | Not reported |
|---|
| Pasireotide LAR 60 mg | 14.96 | 10.210 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.159
- value
- 5.70
- denoms
- counts
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Week 48
- categories
- measurements
- group Id
- OG000
- spread
- 4.154
- value
- 8.66
- group Id
- OG001
- spread
- 9.807
- value
- 14.06
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 72
- units
- Participants
- title
- Week 112
- categories
- measurements
- group Id
- OG000
- spread
- 5.067
- value
- 9.28
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Week 132
- categories
- measurements
- group Id
- OG000
- spread
- 5.473
- value
- 10.32
- group Id
- OG001
- spread
- 10.210
- value
- 14.96
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 65
- units
- Participants
- title
- Week 196
- denoms
- counts
- group Id
- OG000
- value
- 116
- group Id
- OG001
- value
- 93
- units
- Participants
- description
- PK samples were collected for those patients treated with pasireotide LAR in the core study and who continued on pasireotide LAR in the extension phase. PK samples were collected before the injection of pasireotide LAR only at weeks 112 and 196. PK samples were also collected at weeks 48 and 132 only for all patients treated with octreotide LAR 30 mg or lanreotide ATG 120 mg in the core study who started treatment with pasireotide LAR in the extension study.
Blood samples (2.5 mL each sample) were collected to yield 1-mL plasma for analysis of pasireotide LAR oncentration.
- dispersion Type
- Standard Deviation
- groups
- description
- Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
- id
- OG000
- title
- Pasireotide LAR 40 mg
- description
- Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
- id
- OG001
- title
- Pasireotide LAR 60 mg
- param Type
- MEAN
- population Description
- Available data for analysis varies at visits
- reporting Status
- POSTED
- time Frame
- Extension baseline up to approximately 196 weeks
- title
- Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set)
- type
- SECONDARY
- unit Of Measure
- mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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