TriangleNCT02411448 · OUTCOME
Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
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, Cycle 28 (each cycle is 2 weeks)
What was measured
The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.
Analysis population: Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.
Groups in this outcome
Part B: Ramucirumab+ Erlotinib
Part B: 10 mg/kg ramucirumab every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Part B: Placebo+ Erlotinib
Part B: Placebo every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
| Group | Source count |
|---|---|
| Part B: Ramucirumab+ Erlotinib | 108 |
| Part B: Placebo+ Erlotinib | 81 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Ramucirumab+ Erlotinib | 0.02 | 0.18 | Not reported | Not reported | Not reported |
| Part B: Placebo+ Erlotinib | 0.01 | 0.1 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.18
- value
- 0.02
- group Id
- OG001
- spread
- 0.1
- value
- 0.01
- denoms
- counts
- group Id
- OG000
- value
- 108
- group Id
- OG001
- value
- 81
- units
- Participants
- description
- The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.
- dispersion Type
- Standard Deviation
- groups
- description
- Part B: 10 mg/kg ramucirumab every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
- id
- OG000
- title
- Part B: Ramucirumab+ Erlotinib
- description
- Part B: Placebo every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
- id
- OG001
- title
- Part B: Placebo+ Erlotinib
- param Type
- MEAN
- population Description
- Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.
- reporting Status
- POSTED
- time Frame
- Baseline, Cycle 28 (each cycle is 2 weeks)
- title
- Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice