NCT03697109 · OUTCOME
Change in Cushing QoL Normalized Total Score During the OL Phase
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Week 22 (end of OL Phase)
What was measured
The Cushing QoL patient questionnaire, which evaluates the health-related QoL in patients with Cushing syndrome, comprises 12 questions, each with 5 possible answers. The total score ranges from 12-60, with a higher score indicating improvement in QoL. The Cushing QoL instrument addresses known problem areas associated with Cushing syndrome including trouble sleeping, wound healing/bruising, irritability/mood swings/anger, self-confidence, physical changes, ability to participate in activities, interactions with friends and family, memory issues, and future health concerns.
Analysis population: The analysis population was patients in the mITT-OL Population.
Groups in this outcome
Relacorilant (OL Phase)
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.
| Group | Source count |
|---|---|
| Relacorilant (OL Phase) | 151 |
Reported measurements
Baseline Cushing QoL Score
| Group | Source count |
|---|---|
| Relacorilant (OL Phase) | 151 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relacorilant (OL Phase) | 41.9 | 19.78 | Not reported | Not reported | Not reported |
Change from Baseline in Cushing QoL Score
| Group | Source count |
|---|---|
| Relacorilant (OL Phase) | 99 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relacorilant (OL Phase) | 7.4 | 14.63 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 19.78
- value
- 41.9
- denoms
- counts
- group Id
- OG000
- value
- 151
- units
- Participants
- title
- Baseline Cushing QoL Score
- categories
- measurements
- group Id
- OG000
- spread
- 14.63
- value
- 7.4
- denoms
- counts
- group Id
- OG000
- value
- 99
- units
- Participants
- title
- Change from Baseline in Cushing QoL Score
- denoms
- counts
- group Id
- OG000
- value
- 151
- units
- Participants
- description
- The Cushing QoL patient questionnaire, which evaluates the health-related QoL in patients with Cushing syndrome, comprises 12 questions, each with 5 possible answers. The total score ranges from 12-60, with a higher score indicating improvement in QoL. The Cushing QoL instrument addresses known problem areas associated with Cushing syndrome including trouble sleeping, wound healing/bruising, irritability/mood swings/anger, self-confidence, physical changes, ability to participate in activities, interactions with friends and family, memory issues, and future health concerns.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.
- id
- OG000
- title
- Relacorilant (OL Phase)
- param Type
- MEAN
- population Description
- The analysis population was patients in the mITT-OL Population.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 22 (end of OL Phase)
- title
- Change in Cushing QoL Normalized Total Score During the OL Phase
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle