NCT01137682 · OUTCOME
Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis 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
- scores on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- CORE baseline up to approximately 24 weeks
What was measured
Acromegaly Quality of Life questionnaire (AcroQoL) is a validated disease specific questionnaire. It contains 22 items divided into two scales: physical aspects (8 items) and psychological aspects (14 items) which is divided in two sub-scales: physical appearance and personal relationships of the patient (seven items each). The total score and sub-scores were calculated using the following formula: ((X -Y) / 4Y) x 100, X=sum of the scores for individual items (between 1 and 5 for each item), Y=number of individual items included in above sum (i.e. 22 for the total score, 8 for the physical sub-score, 14 for the psychological sub-score, 7 for the sub-score 'appearance' and 'personal relations'). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. If more than 25% of items are not completed, results were considered invalid.
Analysis population: Available data available for analysis differed from visit to visit
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 | 57 |
|---|
| Pasireotide LAR 60 mg | 54 |
|---|
Reported measurements
Week 4 CORE
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide LAR 40 mg | 55 |
|---|
| Pasireotide LAR 60 mg | 52 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR 40 mg | 3.5 | 11.28 | Not reported | Not reported | Not reported |
|---|
| Pasireotide LAR 60 mg | 2.3 | 11.08 | Not reported | Not reported | Not reported |
|---|
Week 8 CORE
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide LAR 40 mg | 54 |
|---|
| Pasireotide LAR 60 mg | 52 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR 40 mg | 2.4 | 12.97 | Not reported | Not reported | Not reported |
|---|
| Pasireotide LAR 60 mg | 2.5 | 12.11 | Not reported | Not reported | Not reported |
|---|
Week 12 CORE
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide LAR 40 mg | 53 |
|---|
| Pasireotide LAR 60 mg | 50 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR 40 mg | 3.0 | 12.41 | Not reported | Not reported | Not reported |
|---|
| Pasireotide LAR 60 mg | 1.9 | 11.50 | Not reported | Not reported | Not reported |
|---|
Week 16 CORE
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide LAR 40 mg | 55 |
|---|
| Pasireotide LAR 60 mg | 52 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR 40 mg | 3.3 | 12.99 | Not reported | Not reported | Not reported |
|---|
| Pasireotide LAR 60 mg | 6.6 | 15.33 | Not reported | Not reported | Not reported |
|---|
Week 20 CORE
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide LAR 40 mg | 56 |
|---|
| Pasireotide LAR 60 mg | 50 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR 40 mg | 3.5 | 12.89 | Not reported | Not reported | Not reported |
|---|
| Pasireotide LAR 60 mg | 4.0 | 16.02 | Not reported | Not reported | Not reported |
|---|
Week24 CORE
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide LAR 40 mg | 55 |
|---|
| Pasireotide LAR 60 mg | 53 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide LAR 40 mg | 3.0 | 16.61 | Not reported | Not reported | Not reported |
|---|
| Pasireotide LAR 60 mg | 5.4 | 17.77 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 11.28
- value
- 3.5
- group Id
- OG001
- spread
- 11.08
- value
- 2.3
- denoms
- counts
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 52
- units
- Participants
- title
- Week 4 CORE
- categories
- measurements
- group Id
- OG000
- spread
- 12.97
- value
- 2.4
- group Id
- OG001
- spread
- 12.11
- value
- 2.5
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 52
- units
- Participants
- title
- Week 8 CORE
- categories
- measurements
- group Id
- OG000
- spread
- 12.41
- value
- 3.0
- group Id
- OG001
- spread
- 11.50
- value
- 1.9
- denoms
- counts
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 50
- units
- Participants
- title
- Week 12 CORE
- categories
- measurements
- group Id
- OG000
- spread
- 12.99
- value
- 3.3
- group Id
- OG001
- spread
- 15.33
- value
- 6.6
- denoms
- counts
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 52
- units
- Participants
- title
- Week 16 CORE
- categories
- measurements
- group Id
- OG000
- spread
- 12.89
- value
- 3.5
- group Id
- OG001
- spread
- 16.02
- value
- 4.0
- denoms
- counts
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 50
- units
- Participants
- title
- Week 20 CORE
- categories
- measurements
- group Id
- OG000
- spread
- 16.61
- value
- 3.0
- group Id
- OG001
- spread
- 17.77
- value
- 5.4
- denoms
- counts
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 53
- units
- Participants
- title
- Week24 CORE
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 54
- units
- Participants
- description
- Acromegaly Quality of Life questionnaire (AcroQoL) is a validated disease specific questionnaire. It contains 22 items divided into two scales: physical aspects (8 items) and psychological aspects (14 items) which is divided in two sub-scales: physical appearance and personal relationships of the patient (seven items each). The total score and sub-scores were calculated using the following formula: ((X -Y) / 4Y) x 100, X=sum of the scores for individual items (between 1 and 5 for each item), Y=number of individual items included in above sum (i.e. 22 for the total score, 8 for the physical sub-score, 14 for the psychological sub-score, 7 for the sub-score 'appearance' and 'personal relations'). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. If more than 25% of items are not completed, results were considered invalid.
- 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 available for analysis differed from visit to visit
- reporting Status
- POSTED
- time Frame
- CORE baseline up to approximately 24 weeks
- title
- Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set)
- type
- SECONDARY
- unit Of Measure
- scores on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle