NCT04266301 · OUTCOME
Change From Baseline of Global Health Status/Quality of Life Scores Using European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQ-C30).
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Scores on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to Cycle 12 Day 1 (C12D1) (1 cycle = 28 days)
What was measured
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer participants. Participant's responses to 2 questions (Items 29+30: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. Change from baseline to Cycle 12 Day 1 as presented.
Analysis population: FAS population with non-missing baseline (Cycle 1 Day 1) and Cycle 12 Day 1 EORTC-QLQ-C30 assessments. FAS comprised of all patients to whom study treatment had been assigned by randomization.
Groups in this outcome
Sabatolimab (MBG453) + Azacitidine
Participants were randomized to sabatolimab plus Azacitidine
Placebo + Azacitidine
Participants were randomized to placebo plus Azacitidine
| Group | Source count |
|---|---|
| Sabatolimab (MBG453) + Azacitidine | 64 |
| Placebo + Azacitidine | 62 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sabatolimab (MBG453) + Azacitidine | 8.72 | 23.071 | Not reported | Not reported | Not reported |
| Placebo + Azacitidine | 8.20 | 19.932 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 23.071
- value
- 8.72
- group Id
- OG001
- spread
- 19.932
- value
- 8.20
- denoms
- counts
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 62
- units
- Participants
- description
- EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer participants. Participant's responses to 2 questions (Items 29+30: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. Change from baseline to Cycle 12 Day 1 as presented.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants were randomized to sabatolimab plus Azacitidine
- id
- OG000
- title
- Sabatolimab (MBG453) + Azacitidine
- description
- Participants were randomized to placebo plus Azacitidine
- id
- OG001
- title
- Placebo + Azacitidine
- param Type
- MEAN
- population Description
- FAS population with non-missing baseline (Cycle 1 Day 1) and Cycle 12 Day 1 EORTC-QLQ-C30 assessments. FAS comprised of all patients to whom study treatment had been assigned by randomization.
- reporting Status
- POSTED
- time Frame
- Up to Cycle 12 Day 1 (C12D1) (1 cycle = 28 days)
- title
- Change From Baseline of Global Health Status/Quality of Life Scores Using European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQ-C30).
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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