TriangleNCT01582061 · OUTCOME
Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent change in score
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, week 12, 24 and 48
What was measured
A 12-item Cushing's syndrome HRQoL questionnaire (CushingQoL, cf. Webb et al 2008) was implemented and patients who completed 9 or more items at a visit were considered evaluable for that visit. The standardized scores were calculated as follows: 1) Obtain raw scores, denoted by X, as the sum of all the ratings on all the HRQoL questions for a single patient and the score can range from 12 (worst HRQoL) to 60 points (best HRQoL). Therefore, the lower the score, greater the negative impact on HRQoL and 2) obtain standardized score, Y, for a single patient • Y = 100 (X-12) / (60-12) = 100 (X-12)/48. For example, if a patient answers all 12 items with 'Sometimes' or 'Somewhat', X = 36 and Y = 100 ∙ 24/48 = 50 The WPAI-GH questionnaire was used to assess work productivity and activity impairment. However, there was very limited baseline data and therefore the results and outcomes of the objective, 'change from baseline in WPAI-GH scores' are not included.
Analysis population: Only patients who completed at least 9 questions on questionnaire were included for that visit.
Groups in this outcome
Pasireotide 600 μg
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.
Pasireotide 900 μg
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
All Patients
Patients received pasireotide 600 μg or 900 μg BID
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 47 |
| Pasireotide 900 μg | 54 |
| All Patients | 101 |
Reported measurements
Week 12
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 33 |
| Pasireotide 900 μg | 45 |
| All Patients | 78 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | 21.3 | 47.03 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | 100.8 | 252.25 | Not reported | Not reported | Not reported |
| All Patients | 67.1 | 197.09 | Not reported | Not reported | Not reported |
Week 24
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 23 |
| Pasireotide 900 μg | 28 |
| All Patients | 51 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | 36.7 | 59.25 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | 119.7 | 321.61 | Not reported | Not reported | Not reported |
| All Patients | 82.3 | 243.19 | Not reported | Not reported | Not reported |
Week 48
| Group | Source count |
|---|---|
| Pasireotide 600 μg | 15 |
| Pasireotide 900 μg | 20 |
| All Patients | 35 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide 600 μg | 24.0 | 37.76 | Not reported | Not reported | Not reported |
| Pasireotide 900 μg | 42.3 | 60.75 | Not reported | Not reported | Not reported |
| All Patients | 34.4 | 52.29 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 47.03
- value
- 21.3
- group Id
- OG001
- spread
- 252.25
- value
- 100.8
- group Id
- OG002
- spread
- 197.09
- value
- 67.1
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 45
- group Id
- OG002
- value
- 78
- units
- Participants
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 59.25
- value
- 36.7
- group Id
- OG001
- spread
- 321.61
- value
- 119.7
- group Id
- OG002
- spread
- 243.19
- value
- 82.3
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 51
- units
- Participants
- title
- Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 37.76
- value
- 24.0
- group Id
- OG001
- spread
- 60.75
- value
- 42.3
- group Id
- OG002
- spread
- 52.29
- value
- 34.4
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 35
- units
- Participants
- title
- Week 48
- denoms
- counts
- group Id
- OG000
- value
- 47
- group Id
- OG001
- value
- 54
- group Id
- OG002
- value
- 101
- units
- Participants
- description
- A 12-item Cushing's syndrome HRQoL questionnaire (CushingQoL, cf. Webb et al 2008) was implemented and patients who completed 9 or more items at a visit were considered evaluable for that visit. The standardized scores were calculated as follows: 1) Obtain raw scores, denoted by X, as the sum of all the ratings on all the HRQoL questions for a single patient and the score can range from 12 (worst HRQoL) to 60 points (best HRQoL). Therefore, the lower the score, greater the negative impact on HRQoL and 2) obtain standardized score, Y, for a single patient • Y = 100 (X-12) / (60-12) = 100 (X-12)/48. For example, if a patient answers all 12 items with 'Sometimes' or 'Somewhat', X = 36 and Y = 100 ∙ 24/48 = 50 The WPAI-GH questionnaire was used to assess work productivity and activity impairment. However, there was very limited baseline data and therefore the results and outcomes of the objective, 'change from baseline in WPAI-GH scores' are not included.
- dispersion Type
- Standard Deviation
- groups
- description
- Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.
- id
- OG000
- title
- Pasireotide 600 μg
- description
- Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
- id
- OG001
- title
- Pasireotide 900 μg
- description
- Patients received pasireotide 600 μg or 900 μg BID
- id
- OG002
- title
- All Patients
- param Type
- MEAN
- population Description
- Only patients who completed at least 9 questions on questionnaire were included for that visit.
- reporting Status
- POSTED
- time Frame
- Baseline, week 12, 24 and 48
- title
- Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores
- type
- SECONDARY
- unit Of Measure
- percent change in score
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Preserved source evidence · Not medical advice