TriangleNCT03474107 · OUTCOME
Change From Baseline to Week 12 in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)
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 12
What was measured
EQ-5D-5L is a health status instrument for self-reported assessment of 5 domains of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain is rated by selecting 1 of 5 standardized categorizations ranging from no problem to extreme problem. The final question is a visual analogue scale (VAS) to rank health status from 0 (best health imaginable) to 100 (worst health imaginable).
Analysis population: FAS population with available data.
Groups in this outcome
Enfortumab Vedotin 1.25 mg/kg
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Chemotherapy
Participants received either 75 mg/m\^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
| Group | Source count |
|---|---|
| Enfortumab Vedotin 1.25 mg/kg | 124 |
| Chemotherapy | 102 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enfortumab Vedotin 1.25 mg/kg | -1.8 | 16.6 | Not reported | Not reported | Not reported |
| Chemotherapy | -5.3 | 14.5 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 16.6
- value
- -1.8
- group Id
- OG001
- spread
- 14.5
- value
- -5.3
- denoms
- counts
- group Id
- OG000
- value
- 124
- group Id
- OG001
- value
- 102
- units
- Participants
- description
- EQ-5D-5L is a health status instrument for self-reported assessment of 5 domains of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain is rated by selecting 1 of 5 standardized categorizations ranging from no problem to extreme problem. The final question is a visual analogue scale (VAS) to rank health status from 0 (best health imaginable) to 100 (worst health imaginable).
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
- id
- OG000
- title
- Enfortumab Vedotin 1.25 mg/kg
- description
- Participants received either 75 mg/m\^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
- id
- OG001
- title
- Chemotherapy
- param Type
- MEAN
- population Description
- FAS population with available data.
- reporting Status
- POSTED
- time Frame
- Baseline and week 12
- title
- Change From Baseline to Week 12 in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice