TriangleNCT03483103 · OUTCOME
Health-Related Quality of Life (HRQoL) Assessed by the EuroQol Instrument EQ-5D-5L
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Scores on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Day 29
What was measured
The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-5L health states ranged from -.594 for the worst (55555) to 1 for the best (11111) for UK value set with an optimal health state is assigned a score of 1.00, death is assigned a score of 0.00 and negative values representing values as worse than dead. A change of .08 is considered to be a clinically meaningful change in health utility.
Analysis population: All participants who received at least one JCAR017 infusion who completed 5-dimension measures at baseline and at least one post-baseline
Groups in this outcome
Lisocabtagene Maraleucel (JCAR017)
Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
| Group | Source count |
|---|---|
| Lisocabtagene Maraleucel (JCAR017) | 55 |
Reported measurements
Baseline
| Group | Source count |
|---|---|
| Lisocabtagene Maraleucel (JCAR017) | 55 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lisocabtagene Maraleucel (JCAR017) | 0.7378 | 0.23190 | Not reported | Not reported | Not reported |
Day 29
| Group | Source count |
|---|---|
| Lisocabtagene Maraleucel (JCAR017) | 46 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lisocabtagene Maraleucel (JCAR017) | 0.7719 | 0.20651 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.23190
- value
- 0.7378
- denoms
- counts
- group Id
- OG000
- value
- 55
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 0.20651
- value
- 0.7719
- denoms
- counts
- group Id
- OG000
- value
- 46
- units
- Participants
- title
- Day 29
- denoms
- counts
- group Id
- OG000
- value
- 55
- units
- Participants
- description
- The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-5L health states ranged from -.594 for the worst (55555) to 1 for the best (11111) for UK value set with an optimal health state is assigned a score of 1.00, death is assigned a score of 0.00 and negative values representing values as worse than dead. A change of .08 is considered to be a clinically meaningful change in health utility.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
- id
- OG000
- title
- Lisocabtagene Maraleucel (JCAR017)
- param Type
- MEAN
- population Description
- All participants who received at least one JCAR017 infusion who completed 5-dimension measures at baseline and at least one post-baseline
- reporting Status
- POSTED
- time Frame
- Baseline and Day 29
- title
- Health-Related Quality of Life (HRQoL) Assessed by the EuroQol Instrument EQ-5D-5L
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice