TriangleNCT03697109 · OUTCOME
Change in Cushing Quality of Life (QoL) Normalized Total Score During the RW Phase
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Week 22 (end of OL Phase) and Week 36 (Week 12 of RW 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 ITT-RW Population.
Groups in this outcome
Relacorilant (RW Phase)
Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.
Placebo (RW Phase)
Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug. Placebo: Placebo matched to study drug
| Group | Source count |
|---|---|
| Relacorilant (RW Phase) | 27 |
| Placebo (RW Phase) | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relacorilant (RW Phase) | 0.59 | Not reported | -4.28 | 5.46 | Not reported |
| Placebo (RW Phase) | -0.58 | Not reported | -5.14 | 3.98 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -4.28
- upper Limit
- 5.46
- value
- 0.59
- group Id
- OG001
- lower Limit
- -5.14
- upper Limit
- 3.98
- value
- -0.58
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 31
- 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
- 95% Confidence Interval
- groups
- description
- Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.
- id
- OG000
- title
- Relacorilant (RW Phase)
- description
- Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug. Placebo: Placebo matched to study drug
- id
- OG001
- title
- Placebo (RW Phase)
- param Type
- LEAST_SQUARES_MEAN
- population Description
- The analysis population was patients in the ITT-RW Population.
- reporting Status
- POSTED
- time Frame
- Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
- title
- Change in Cushing Quality of Life (QoL) Normalized Total Score During the RW 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