TriangleNCT01170663 · OUTCOME
Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, end of therapy (up to 103 weeks)
What was measured
EORTC QLQ-C30 v3.0 is a 30-item, self-administered questionnaire with multidimensional scales assessing 15 domains (5 functional domains \[physical, role, cognitive, emotional, and social\], 9 symptom scales \[fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties\] and global health status scale). 28 questions assessed on a 1 (not at all) to 4 (very much) scale and the remaining 2 questions used a 1 (poor) to 7 (excellent) scale. A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
Analysis population: All participants according to the treatment group to which they were randomized with baseline and end of treatment Global Health Status observations.
Groups in this outcome
Ramucirumab (IMC-1211B) Plus Paclitaxel
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Placebo Plus Paclitaxel
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
| Group | Source count |
|---|---|
| Ramucirumab (IMC-1211B) Plus Paclitaxel | 209 |
| Placebo Plus Paclitaxel | 202 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab (IMC-1211B) Plus Paclitaxel | -13.5 | 23.24 | Not reported | Not reported | Not reported |
| Placebo Plus Paclitaxel | -12.1 | 24.81 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.3973
- p Value Comment
- Analysis of covariance (ANCOVA) included treatment group, randomization stratification factors and baseline value of Global Health Status scale.
- statistical Method
- ANCOVA
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.3973
- p Value Comment
- Analysis of covariance (ANCOVA) included treatment group, randomization stratification factors and baseline value of Global Health Status scale.
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 23.24
- value
- -13.5
- group Id
- OG001
- spread
- 24.81
- value
- -12.1
- denoms
- counts
- group Id
- OG000
- value
- 209
- group Id
- OG001
- value
- 202
- units
- Participants
- description
- EORTC QLQ-C30 v3.0 is a 30-item, self-administered questionnaire with multidimensional scales assessing 15 domains (5 functional domains \[physical, role, cognitive, emotional, and social\], 9 symptom scales \[fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties\] and global health status scale). 28 questions assessed on a 1 (not at all) to 4 (very much) scale and the remaining 2 questions used a 1 (poor) to 7 (excellent) scale. A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
- dispersion Type
- Standard Deviation
- groups
- description
- 8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
- id
- OG000
- title
- Ramucirumab (IMC-1211B) Plus Paclitaxel
- description
- Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
- id
- OG001
- title
- Placebo Plus Paclitaxel
- param Type
- MEAN
- population Description
- All participants according to the treatment group to which they were randomized with baseline and end of treatment Global Health Status observations.
- reporting Status
- POSTED
- time Frame
- Baseline, end of therapy (up to 103 weeks)
- title
- Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice