NCT01915303 · OUTCOME
Mean Scores of Cushing QoL Standardized Score at Week 17 and 35
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 and week 17 and 35
What was measured
Patients who completed nine or more items for the 12-item Cushing's syndrome QoL questionaire were considered evaluable for that assessment. Raw scores were obtained for the 12 items using the following scoring: 1) always or very much, 2) often or quite a bit, 3) sometimes or somewhat, 4) rarely or very little, 5) never or not at all. Then the standardized score, Y, was calculated for each patient as follows: Y = 100\* (X - n) / n\*5 - n\*1) = 100 \* (X - n) / 4\*n where X denoted the raw score and n the number of questions answered by the patient. The higher the score, the better the QoL. The best possible standardized score was 100 and the worst possible standardized score was 0
Analysis population: Full analysis set
Groups in this outcome
All Patients
Pasireotide montherapy (0.6 mg bid to 0.9 mg bid) was administered until the biochemical control was achieved and if not achieved, a combination was administered: pasireotide (0.9 mg bid) + cabergoline (0.5 QD to 1 mg QD). Patients were able to add cabergoline at anytime during core and extension
| Group | Source count |
|---|---|
| All Patients | 68 |
Reported measurements
Baseline Mean
| Group | Source count |
|---|---|
| All Patients | 68 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Patients | 41.6 | 20.2 | Not reported | Not reported | Not reported |
Week 17 n=54
| Group | Source count |
|---|---|
| All Patients | 54 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Patients | 46.3 | 19.7 | Not reported | Not reported | Not reported |
Week 35 n=40
| Group | Source count |
|---|---|
| All Patients | 40 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Patients | 47.6 | 20.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 20.2
- value
- 41.6
- denoms
- counts
- group Id
- OG000
- value
- 68
- units
- Participants
- title
- Baseline Mean
- categories
- measurements
- group Id
- OG000
- spread
- 19.7
- value
- 46.3
- denoms
- counts
- group Id
- OG000
- value
- 54
- units
- Participants
- title
- Week 17 n=54
- categories
- measurements
- group Id
- OG000
- spread
- 20.8
- value
- 47.6
- denoms
- counts
- group Id
- OG000
- value
- 40
- units
- Participants
- title
- Week 35 n=40
- denoms
- counts
- group Id
- OG000
- value
- 68
- units
- Participants
- description
- Patients who completed nine or more items for the 12-item Cushing's syndrome QoL questionaire were considered evaluable for that assessment. Raw scores were obtained for the 12 items using the following scoring: 1) always or very much, 2) often or quite a bit, 3) sometimes or somewhat, 4) rarely or very little, 5) never or not at all. Then the standardized score, Y, was calculated for each patient as follows: Y = 100\* (X - n) / n\*5 - n\*1) = 100 \* (X - n) / 4\*n where X denoted the raw score and n the number of questions answered by the patient. The higher the score, the better the QoL. The best possible standardized score was 100 and the worst possible standardized score was 0
- dispersion Type
- Standard Deviation
- groups
- description
- Pasireotide montherapy (0.6 mg bid to 0.9 mg bid) was administered until the biochemical control was achieved and if not achieved, a combination was administered: pasireotide (0.9 mg bid) + cabergoline (0.5 QD to 1 mg QD). Patients were able to add cabergoline at anytime during core and extension
- id
- OG000
- title
- All Patients
- param Type
- MEAN
- population Description
- Full analysis set
- reporting Status
- POSTED
- time Frame
- Baseline and week 17 and 35
- title
- Mean Scores of Cushing QoL Standardized Score at Week 17 and 35
- type
- SECONDARY
- unit Of Measure
- scores on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle