TriangleNCT01761266 · OUTCOME
Time to Clinically Meaningful Worsening of HRQoL Assessed Using EuroQol Five Dimension Health Questionnaire (EQ-5D-3L)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline up to Off-Treatment Visit (approximately up to 3.8 years)
What was measured
The EuroQol five dimension health questionnaire (EQ-5D-3L) assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 3-15 with "3" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. EQ-5D-3L also included an EQ visual analogue scale (VAS) that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score was weighted with a range of -0.594 (worst) to 1.0 (best). EQ-5D-3L also included an EQ health utilities index (HUI) where 1.00 indicated perfect health while a score of 0.00 indicated death. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date.
Analysis population: The FAS included all participants who were randomized.
Groups in this outcome
Lenvatinib
Subjects received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (\>=) 60 kilogram (kg) or 8 mg based on the subject's body weight less than (\<) 60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Sorafenib
Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
| Group | Source count |
|---|---|
| Lenvatinib | 478 |
| Sorafenib | 476 |
Reported measurements
VAS
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenvatinib | 2.8 | 2.17 | 2.17 | 3.65 | Not reported |
| Sorafenib | 1.9 | 1.84 | 1.84 | 2.33 | Not reported |
HUI
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenvatinib | 2.8 | 1.97 | 1.97 | 3.52 | Not reported |
| Sorafenib | 1.9 | 1.84 | 1.84 | 2.66 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.17
- spread
- 2.17
- upper Limit
- 3.65
- value
- 2.8
- group Id
- OG001
- lower Limit
- 1.84
- spread
- 1.84
- upper Limit
- 2.33
- value
- 1.9
- title
- VAS
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.97
- spread
- 1.97
- upper Limit
- 3.52
- value
- 2.8
- group Id
- OG001
- lower Limit
- 1.84
- spread
- 1.84
- upper Limit
- 2.66
- value
- 1.9
- title
- HUI
- denoms
- counts
- group Id
- OG000
- value
- 478
- group Id
- OG001
- value
- 476
- units
- Participants
- description
- The EuroQol five dimension health questionnaire (EQ-5D-3L) assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 3-15 with "3" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. EQ-5D-3L also included an EQ visual analogue scale (VAS) that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score was weighted with a range of -0.594 (worst) to 1.0 (best). EQ-5D-3L also included an EQ health utilities index (HUI) where 1.00 indicated perfect health while a score of 0.00 indicated death. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Subjects received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (\>=) 60 kilogram (kg) or 8 mg based on the subject's body weight less than (\<) 60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
- id
- OG000
- title
- Lenvatinib
- description
- Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
- id
- OG001
- title
- Sorafenib
- param Type
- MEDIAN
- population Description
- The FAS included all participants who were randomized.
- reporting Status
- POSTED
- time Frame
- Baseline up to Off-Treatment Visit (approximately up to 3.8 years)
- title
- Time to Clinically Meaningful Worsening of HRQoL Assessed Using EuroQol Five Dimension Health Questionnaire (EQ-5D-3L)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice