TriangleNCT01001377 · OUTCOME
Change From Baseline in NCCN FCSI Functional Well-being Scale 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 FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).
Analysis population: Patient reported outcomes (PRO) analysis set participants with available data.
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 | 152 |
| Panitumumab | 143 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cetuximab | 1.3567 | Not reported | -4.1564 | 6.8697 | Not reported |
| Panitumumab | 1.1569 | Not reported | -4.4887 | 6.8025 | Not reported |
Source statistical analyses
- ci Lower Limit
- -6.0093
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.6098
- 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
- -0.1998
Complete source fields
- analyses
- ci Lower Limit
- -6.0093
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.6098
- 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
- -0.1998
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -4.1564
- upper Limit
- 6.8697
- value
- 1.3567
- group Id
- OG001
- lower Limit
- -4.4887
- upper Limit
- 6.8025
- value
- 1.1569
- denoms
- counts
- group Id
- OG000
- value
- 152
- group Id
- OG001
- value
- 143
- units
- Participants
- description
- The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).
- 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 participants with available data.
- 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 NCCN FCSI Functional Well-being Scale Score
- type
- SECONDARY
- unit Of Measure
- scores on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice