TriangleNCT02737501 · OUTCOME
Change From Baseline in Global Health Status/Quality of Life as Assessed by EORTC QLQ-C30 (Version 3.0)
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 and Month 36
What was measured
HRQoL: perceived quality of participant's life, includes self-reported multidimensional measures of physical and mental health. Patient-reported symptoms (PROs) and HRQoL will be collected by administering the european organisation for research and treatment of cancer (EORTC) quality of life (QLQ)-C30 questionnaire. EORTC-QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. The 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Raw scores are converted into overall score ranging from 0 to 100, where lower scores indicate better QOL. A negative change from Baseline indicates improvement.
Analysis population: ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses.
Groups in this outcome
Randomized Phase: Brigatinib 90 mg QD/180 QD
Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
Randomized Phase: Crizotinib 250 mg BID
Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
| Group | Source count |
|---|---|
| Randomized Phase: Brigatinib 90 mg QD/180 QD | 104 |
| Randomized Phase: Crizotinib 250 mg BID | 53 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomized Phase: Brigatinib 90 mg QD/180 QD | 4.007 | 25.7563 | Not reported | Not reported | Not reported |
| Randomized Phase: Crizotinib 250 mg BID | -4.088 | 27.4748 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.00
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0295
- p Value Comment
- p-values were obtained using mixed effects models stratified by presence of iCNS metastases at study entry, prior chemotherapy at Baseline.
- param Type
- Least Square Mean Difference
- param Value
- 5.79
- statistical Comment
- A mixed effect model is used with an unstructured covariance matrix.
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Lower Limit
- 0.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.00
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0295
- p Value Comment
- p-values were obtained using mixed effects models stratified by presence of iCNS metastases at study entry, prior chemotherapy at Baseline.
- param Type
- Least Square Mean Difference
- param Value
- 5.79
- statistical Comment
- A mixed effect model is used with an unstructured covariance matrix.
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 25.7563
- value
- 4.007
- group Id
- OG001
- spread
- 27.4748
- value
- -4.088
- denoms
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 53
- units
- Participants
- description
- HRQoL: perceived quality of participant's life, includes self-reported multidimensional measures of physical and mental health. Patient-reported symptoms (PROs) and HRQoL will be collected by administering the european organisation for research and treatment of cancer (EORTC) quality of life (QLQ)-C30 questionnaire. EORTC-QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. The 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Raw scores are converted into overall score ranging from 0 to 100, where lower scores indicate better QOL. A negative change from Baseline indicates improvement.
- dispersion Type
- Standard Deviation
- groups
- description
- Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
- id
- OG000
- title
- Randomized Phase: Brigatinib 90 mg QD/180 QD
- description
- Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
- id
- OG001
- title
- Randomized Phase: Crizotinib 250 mg BID
- param Type
- MEAN
- population Description
- ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses.
- reporting Status
- POSTED
- time Frame
- Baseline and Month 36
- title
- Change From Baseline in Global Health Status/Quality of Life as Assessed by EORTC QLQ-C30 (Version 3.0)
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice