TriangleNCT02181413 · OUTCOME
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Domain Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline up to EOT (up to Month 24)
What was measured
The EORTC QLQ-C30 is a 30-item questionnaire used to assess the health-related quality of life of cancer patients. GHS/QoL domain is based on questions 29 ("How would you rate your overall health during the past week?") and 30 ("How would you rate your overall quality of life during the past week?") of the EORTC QLQ-C30 where the study participants' self-reported responses to the questions on a 7-point scale (1=very poor to 7=excellent). The raw GHS/QoL domain scores were linearly transformed to a scale ranging 0 (worse outcome) to 100 (best outcome), with higher scores indicating better quality of life. The change from baseline in EORTC QLQ-C30 GHS/QoL domain was evaluated by treatment group.
Analysis population: ITT Population was defined as all participants who were randomized and had post randomization data. Overall number of participants analyzed indicates the number of participants with data available for analysis.
Groups in this outcome
Placebo
Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.
Ixazomib Citrate
Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
| Group | Source count |
|---|---|
| Placebo | 237 |
| Ixazomib Citrate | 349 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -1.7 | 1.57 | Not reported | Not reported | Not reported |
| Ixazomib Citrate | -4.1 | 1.43 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -4.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.2
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.074
- param Type
- Least Squares (LS) Mean Difference
- param Value
- -2.3
- statistical Comment
- P-value was from the significance test for the coefficient of the interaction between treatment and visit.
- statistical Method
- t-test, 2 sided
Complete source fields
- analyses
- ci Lower Limit
- -4.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.2
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.074
- param Type
- Least Squares (LS) Mean Difference
- param Value
- -2.3
- statistical Comment
- P-value was from the significance test for the coefficient of the interaction between treatment and visit.
- statistical Method
- t-test, 2 sided
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.57
- value
- -1.7
- group Id
- OG001
- spread
- 1.43
- value
- -4.1
- denoms
- counts
- group Id
- OG000
- value
- 237
- group Id
- OG001
- value
- 349
- units
- Participants
- description
- The EORTC QLQ-C30 is a 30-item questionnaire used to assess the health-related quality of life of cancer patients. GHS/QoL domain is based on questions 29 ("How would you rate your overall health during the past week?") and 30 ("How would you rate your overall quality of life during the past week?") of the EORTC QLQ-C30 where the study participants' self-reported responses to the questions on a 7-point scale (1=very poor to 7=excellent). The raw GHS/QoL domain scores were linearly transformed to a scale ranging 0 (worse outcome) to 100 (best outcome), with higher scores indicating better quality of life. The change from baseline in EORTC QLQ-C30 GHS/QoL domain was evaluated by treatment group.
- dispersion Type
- Standard Error
- groups
- description
- Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.
- id
- OG000
- title
- Placebo
- description
- Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
- id
- OG001
- title
- Ixazomib Citrate
- param Type
- LEAST_SQUARES_MEAN
- population Description
- ITT Population was defined as all participants who were randomized and had post randomization data. Overall number of participants analyzed indicates the number of participants with data available for analysis.
- reporting Status
- POSTED
- time Frame
- Baseline up to EOT (up to Month 24)
- title
- Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Domain Score
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice