TriangleNCT01001377 · OUTCOME
Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- scores on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
What was measured
The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The health state index measures the following 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension contains 3 levels of response to reflect degree of problems participants have experienced: no problem (1), some problem (2) and extreme problems (3). The health states for each respondent are converted into a single index number using a specified set of weights. Resulting scores can range from 1.0 and -0.594. A higher score indicates a more preferred health status with 1.0 representing perfect health and 0 representing death. Negative scores are possible and represent health states regarded as less preferable than death (0). Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and participants a random effect.
Analysis population: Patient reported outcomes (PRO) analysis set: all participants in the primary analysis set who have a Baseline and at least one follow-up PRO assessment prior to clinical or objective disease progression per RECIST version 1.1. Participants with available data are included.
Groups in this outcome
Cetuximab
Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days.
Panitumumab
Panitumumab 6 mg/kg IV every 14 days.
| Group | Source count |
|---|---|
| Cetuximab | 150 |
| Panitumumab | 143 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cetuximab | -0.0341 | Not reported | -0.0806 | 0.0123 | Not reported |
| Panitumumab | -0.0216 | Not reported | -0.0691 | 0.0260 | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.0353
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.0605
- estimate Comment
- A positive difference between the treatment groups favors the panitumumab group.
- group Description
- Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- LS Mean Difference
- param Value
- 0.0126
Complete source fields
- analyses
- ci Lower Limit
- -0.0353
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.0605
- estimate Comment
- A positive difference between the treatment groups favors the panitumumab group.
- group Description
- Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- LS Mean Difference
- param Value
- 0.0126
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.0806
- upper Limit
- 0.0123
- value
- -0.0341
- group Id
- OG001
- lower Limit
- -0.0691
- upper Limit
- 0.0260
- value
- -0.0216
- denoms
- counts
- group Id
- OG000
- value
- 150
- group Id
- OG001
- value
- 143
- units
- Participants
- description
- The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The health state index measures the following 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension contains 3 levels of response to reflect degree of problems participants have experienced: no problem (1), some problem (2) and extreme problems (3). The health states for each respondent are converted into a single index number using a specified set of weights. Resulting scores can range from 1.0 and -0.594. A higher score indicates a more preferred health status with 1.0 representing perfect health and 0 representing death. Negative scores are possible and represent health states regarded as less preferable than death (0). Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and participants a random effect.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days.
- id
- OG000
- title
- Cetuximab
- description
- Panitumumab 6 mg/kg IV every 14 days.
- id
- OG001
- title
- Panitumumab
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Patient reported outcomes (PRO) analysis set: all participants in the primary analysis set who have a Baseline and at least one follow-up PRO assessment prior to clinical or objective disease progression per RECIST version 1.1. Participants with available data are included.
- reporting Status
- POSTED
- time Frame
- From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
- title
- Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score
- type
- SECONDARY
- unit Of Measure
- scores on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice