TriangleNCT03085095 · OUTCOME
Change From Baseline In QoL Total Score For Urinary And Bowel Symptoms Domains As Assessed By The EORTC-QLQ-PR25
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, Week 49 Day 1 (Day 337)
What was measured
Subscale assessments of urinary symptoms (9 items) and bowel symptoms (4 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. A decrease in symptom scores indicates improvement (lower level of symptoms/problems).
Analysis population: All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.
Groups in this outcome
Relugolix
Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide Acetate
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
| Group | Source count |
|---|---|
| Relugolix | 537 |
| Leuprolide Acetate | 256 |
Reported measurements
Urinary symptoms
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relugolix | 1.1 | 15.29 | Not reported | Not reported | Not reported |
| Leuprolide Acetate | -0.4 | 13.78 | Not reported | Not reported | Not reported |
Incontinence aid use
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relugolix | 1.0 | 15.41 | Not reported | Not reported | Not reported |
| Leuprolide Acetate | 0.0 | 19.80 | Not reported | Not reported | Not reported |
Bowel symptoms
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relugolix | 1.2 | 8.92 | Not reported | Not reported | Not reported |
| Leuprolide Acetate | 2.0 | 9.51 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 15.29
- value
- 1.1
- group Id
- OG001
- spread
- 13.78
- value
- -0.4
- title
- Urinary symptoms
- categories
- measurements
- group Id
- OG000
- spread
- 15.41
- value
- 1.0
- group Id
- OG001
- spread
- 19.80
- value
- 0.0
- title
- Incontinence aid use
- categories
- measurements
- group Id
- OG000
- spread
- 8.92
- value
- 1.2
- group Id
- OG001
- spread
- 9.51
- value
- 2.0
- title
- Bowel symptoms
- denoms
- counts
- group Id
- OG000
- value
- 537
- group Id
- OG001
- value
- 256
- units
- Participants
- description
- Subscale assessments of urinary symptoms (9 items) and bowel symptoms (4 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. A decrease in symptom scores indicates improvement (lower level of symptoms/problems).
- dispersion Type
- Standard Deviation
- groups
- description
- Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
- id
- OG000
- title
- Relugolix
- description
- Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
- id
- OG001
- title
- Leuprolide Acetate
- param Type
- MEAN
- population Description
- All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 49 Day 1 (Day 337)
- title
- Change From Baseline In QoL Total Score For Urinary And Bowel Symptoms Domains As Assessed By The EORTC-QLQ-PR25
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice