TriangleNCT02354508 · OUTCOME
Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL)
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
- Baseline, Weeks 12, 24 & 36
What was measured
Evaluation of effect of pasireotide LAR on Health Related Quality of Life (HRQoL) was assessed using AcroQoL, an acromegaly-specific quality of life instrument. The AcroQol instrument is comprised of 22 questions divided into two scales: one evaluating physical aspects (8 items) and the other that addresses psychological aspects (14 items). The psychological scale can also be further divided into subscale that evaluates physical appearance and the other subscale focused on the impact of the disease on personal relationships of the patient (7 items each). Each of the questions has a 5-item Likert scale. For each dimension the scores range from 0-4 with 0 being the lowest impact and 4 being the most severe.
Analysis population: 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
Pasireotide LAR Overall - AcroQOL Total Scores
This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
Pasireotide LAR Overall - AcroQOL Physical Sub-scores
This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
Pasireotide LAR Overall - AcroQOL Psychological Sub-scores
This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores
This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores
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 |
|---|---|
| Pasireotide LAR Overall - AcroQOL Total Scores | 123 |
| Pasireotide LAR Overall - AcroQOL Physical Sub-scores | 123 |
| Pasireotide LAR Overall - AcroQOL Psychological Sub-scores | 123 |
| Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores | 123 |
| Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores | 123 |
Reported measurements
Week 12
| Group | Source count |
|---|---|
| Pasireotide LAR Overall - AcroQOL Total Scores | 120 |
| Pasireotide LAR Overall - AcroQOL Physical Sub-scores | 120 |
| Pasireotide LAR Overall - AcroQOL Psychological Sub-scores | 120 |
| Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores | 120 |
| Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores | 118 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide LAR Overall - AcroQOL Total Scores | 4.5 | 9.52 | Not reported | Not reported | Not reported |
| Pasireotide LAR Overall - AcroQOL Physical Sub-scores | 5.3 | 12.93 | Not reported | Not reported | Not reported |
| Pasireotide LAR Overall - AcroQOL Psychological Sub-scores | 4.1 | 10.05 | Not reported | Not reported | Not reported |
| Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores | 6.5 | 12.43 | Not reported | Not reported | Not reported |
| Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores | 1.9 | 12.04 | Not reported | Not reported | Not reported |
Week 24
| Group | Source count |
|---|---|
| Pasireotide LAR Overall - AcroQOL Total Scores | 118 |
| Pasireotide LAR Overall - AcroQOL Physical Sub-scores | 118 |
| Pasireotide LAR Overall - AcroQOL Psychological Sub-scores | 118 |
| Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores | 118 |
| Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores | 117 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide LAR Overall - AcroQOL Total Scores | 4.7 | 9.88 | Not reported | Not reported | Not reported |
| Pasireotide LAR Overall - AcroQOL Physical Sub-scores | 5.8 | 12.26 | Not reported | Not reported | Not reported |
| Pasireotide LAR Overall - AcroQOL Psychological Sub-scores | 4.0 | 10.72 | Not reported | Not reported | Not reported |
| Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores | 7.2 | 14.44 | Not reported | Not reported | Not reported |
| Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores | 0.9 | 10.70 | Not reported | Not reported | Not reported |
Week 36
| Group | Source count |
|---|---|
| Pasireotide LAR Overall - AcroQOL Total Scores | 110 |
| Pasireotide LAR Overall - AcroQOL Physical Sub-scores | 110 |
| Pasireotide LAR Overall - AcroQOL Psychological Sub-scores | 109 |
| Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores | 110 |
| Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores | 108 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide LAR Overall - AcroQOL Total Scores | 4.6 | 10.14 | Not reported | Not reported | Not reported |
| Pasireotide LAR Overall - AcroQOL Physical Sub-scores | 5.4 | 13.00 | Not reported | Not reported | Not reported |
| Pasireotide LAR Overall - AcroQOL Psychological Sub-scores | 4.3 | 11.02 | Not reported | Not reported | Not reported |
| Pasireotide LAR Overall - AcroQOL Psycho/Appearance Sub-scores | 7.0 | 15.33 | Not reported | Not reported | Not reported |
| Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores | 1.8 | 10.69 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 9.52
- value
- 4.5
- group Id
- OG001
- spread
- 12.93
- value
- 5.3
- group Id
- OG002
- spread
- 10.05
- value
- 4.1
- group Id
- OG003
- spread
- 12.43
- value
- 6.5
- group Id
- OG004
- spread
- 12.04
- value
- 1.9
- denoms
- counts
- group Id
- OG000
- value
- 120
- group Id
- OG001
- value
- 120
- group Id
- OG002
- value
- 120
- group Id
- OG003
- value
- 120
- group Id
- OG004
- value
- 118
- units
- Participants
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 9.88
- value
- 4.7
- group Id
- OG001
- spread
- 12.26
- value
- 5.8
- group Id
- OG002
- spread
- 10.72
- value
- 4.0
- group Id
- OG003
- spread
- 14.44
- value
- 7.2
- group Id
- OG004
- spread
- 10.70
- value
- 0.9
- denoms
- counts
- group Id
- OG000
- value
- 118
- group Id
- OG001
- value
- 118
- group Id
- OG002
- value
- 118
- group Id
- OG003
- value
- 118
- group Id
- OG004
- value
- 117
- units
- Participants
- title
- Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 10.14
- value
- 4.6
- group Id
- OG001
- spread
- 13.00
- value
- 5.4
- group Id
- OG002
- spread
- 11.02
- value
- 4.3
- group Id
- OG003
- spread
- 15.33
- value
- 7.0
- group Id
- OG004
- spread
- 10.69
- value
- 1.8
- denoms
- counts
- group Id
- OG000
- value
- 110
- group Id
- OG001
- value
- 110
- group Id
- OG002
- value
- 109
- group Id
- OG003
- value
- 110
- group Id
- OG004
- value
- 108
- units
- Participants
- title
- Week 36
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 123
- group Id
- OG002
- value
- 123
- group Id
- OG003
- value
- 123
- group Id
- OG004
- value
- 123
- units
- Participants
- description
- Evaluation of effect of pasireotide LAR on Health Related Quality of Life (HRQoL) was assessed using AcroQoL, an acromegaly-specific quality of life instrument. The AcroQol instrument is comprised of 22 questions divided into two scales: one evaluating physical aspects (8 items) and the other that addresses psychological aspects (14 items). The psychological scale can also be further divided into subscale that evaluates physical appearance and the other subscale focused on the impact of the disease on personal relationships of the patient (7 items each). Each of the questions has a 5-item Likert scale. For each dimension the scores range from 0-4 with 0 being the lowest impact and 4 being the most severe.
- dispersion Type
- Standard Deviation
- groups
- description
- This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
- id
- OG000
- title
- Pasireotide LAR Overall - AcroQOL Total Scores
- description
- This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
- id
- OG001
- title
- Pasireotide LAR Overall - AcroQOL Physical Sub-scores
- description
- This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
- id
- OG002
- title
- Pasireotide LAR Overall - AcroQOL Psychological Sub-scores
- 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 - AcroQOL Psycho/Appearance Sub-scores
- description
- This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
- id
- OG004
- title
- Pasireotide LAR Overall-AcroQOL Psycho/Pers Relatns Sub-scores
- param Type
- MEAN
- population Description
- 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
- Baseline, Weeks 12, 24 & 36
- title
- Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL)
- type
- SECONDARY
- unit Of Measure
- scores on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice