NCT03069352 · OUTCOME
Change From Baseline in Global Health Status / Quality of Life
A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy · Source last updated 2025-09-30
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
- Standard Error
- Time frame
- Baseline and Day 1 of Cycles 3, 5, 7, and 9
What was measured
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) consists of a Global Health Status/Quality of Life (GHS/QoL) scale, a Financial Difficulties scale, 5 functional scales (Cognitive, Social, Physical, Emotional, and Role Functioning), and 8 symptom scales/items (Fatigue, Insomnia, Appetite Loss, Pain, Constipation, Diarrhea, Dyspnea, and Nausea and Vomiting).
The GHS/QoL scale includes 2 questions in which participants were asked to rate their overall health and overall quality of life during the past week on a scale from 1 (very poor) to 7 (excellent). The 2 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life.
Analysis population: Full analysis set with available data at Baseline and each time point
Groups in this outcome
Placebo + Low Dose Cytarabine (LDAC)
Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
Venetoclax + Low Dose Cytarabine (LDAC)
Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + Low Dose Cytarabine (LDAC) | 59 |
|---|
| Venetoclax + Low Dose Cytarabine (LDAC) | 127 |
|---|
Reported measurements
Cycle 3 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + Low Dose Cytarabine (LDAC) | 22 |
|---|
| Venetoclax + Low Dose Cytarabine (LDAC) | 69 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Low Dose Cytarabine (LDAC) | 1.941 | 4.126 | Not reported | Not reported | Not reported |
|---|
| Venetoclax + Low Dose Cytarabine (LDAC) | 4.857 | 2.413 | Not reported | Not reported | Not reported |
|---|
Cycle 5 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + Low Dose Cytarabine (LDAC) | 12 |
|---|
| Venetoclax + Low Dose Cytarabine (LDAC) | 40 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Low Dose Cytarabine (LDAC) | 2.627 | 5.047 | Not reported | Not reported | Not reported |
|---|
| Venetoclax + Low Dose Cytarabine (LDAC) | 16.015 | 2.853 | Not reported | Not reported | Not reported |
|---|
Cycle 7 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + Low Dose Cytarabine (LDAC) | 12 |
|---|
| Venetoclax + Low Dose Cytarabine (LDAC) | 36 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Low Dose Cytarabine (LDAC) | 3.481 | 5.337 | Not reported | Not reported | Not reported |
|---|
| Venetoclax + Low Dose Cytarabine (LDAC) | 10.599 | 3.092 | Not reported | Not reported | Not reported |
|---|
Cycle 9 day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + Low Dose Cytarabine (LDAC) | 7 |
|---|
| Venetoclax + Low Dose Cytarabine (LDAC) | 22 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Low Dose Cytarabine (LDAC) | 6.918 | 6.642 | Not reported | Not reported | Not reported |
|---|
| Venetoclax + Low Dose Cytarabine (LDAC) | 13.299 | 3.772 | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- -6.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.06
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 4.617
- estimate Comment
- A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.
- group Description
- Cycle 3 Day 1
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 2.917
- ci Lower Limit
- 2.18
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.59
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 5.659
- estimate Comment
- A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.
- group Description
- Cycle 5 Day 1
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 13.388
- ci Lower Limit
- -4.83
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 19.06
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 6.031
- estimate Comment
- A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.
- group Description
- Cycle 7 Day 1
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 7.119
- ci Lower Limit
- -8.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 21.26
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 7.511
- estimate Comment
- A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.
- group Description
- Cycle 9 Day 1
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 6.381
- group Description
- A linear mixed effects regression model with a variable covariance structure was fitted to the longitudinal data (considering all time points) to test for differences between treatment arms.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.085
- statistical Comment
- Model included AML status (de novo vs. secondary), age (18-\< 75 vs. ≥ 75), treatment arm, time, and treatment arm by time interaction as fixed factors
- statistical Method
- Linear Mixed Effects Regression Model
Complete source fields
- analyses
- ci Lower Limit
- -6.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.06
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 4.617
- estimate Comment
- A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.
- group Description
- Cycle 3 Day 1
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 2.917
- ci Lower Limit
- 2.18
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.59
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 5.659
- estimate Comment
- A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.
- group Description
- Cycle 5 Day 1
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 13.388
- ci Lower Limit
- -4.83
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 19.06
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 6.031
- estimate Comment
- A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.
- group Description
- Cycle 7 Day 1
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 7.119
- ci Lower Limit
- -8.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 21.26
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 7.511
- estimate Comment
- A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.
- group Description
- Cycle 9 Day 1
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 6.381
- group Description
- A linear mixed effects regression model with a variable covariance structure was fitted to the longitudinal data (considering all time points) to test for differences between treatment arms.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.085
- statistical Comment
- Model included AML status (de novo vs. secondary), age (18-\< 75 vs. ≥ 75), treatment arm, time, and treatment arm by time interaction as fixed factors
- statistical Method
- Linear Mixed Effects Regression Model
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 4.126
- value
- 1.941
- group Id
- OG001
- spread
- 2.413
- value
- 4.857
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 69
- units
- Participants
- title
- Cycle 3 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 5.047
- value
- 2.627
- group Id
- OG001
- spread
- 2.853
- value
- 16.015
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 40
- units
- Participants
- title
- Cycle 5 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 5.337
- value
- 3.481
- group Id
- OG001
- spread
- 3.092
- value
- 10.599
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 36
- units
- Participants
- title
- Cycle 7 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 6.642
- value
- 6.918
- group Id
- OG001
- spread
- 3.772
- value
- 13.299
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 22
- units
- Participants
- title
- Cycle 9 day 1
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 127
- units
- Participants
- description
- The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) consists of a Global Health Status/Quality of Life (GHS/QoL) scale, a Financial Difficulties scale, 5 functional scales (Cognitive, Social, Physical, Emotional, and Role Functioning), and 8 symptom scales/items (Fatigue, Insomnia, Appetite Loss, Pain, Constipation, Diarrhea, Dyspnea, and Nausea and Vomiting).
The GHS/QoL scale includes 2 questions in which participants were asked to rate their overall health and overall quality of life during the past week on a scale from 1 (very poor) to 7 (excellent). The 2 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life.
- dispersion Type
- Standard Error
- groups
- description
- Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
- id
- OG000
- title
- Placebo + Low Dose Cytarabine (LDAC)
- description
- Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
- id
- OG001
- title
- Venetoclax + Low Dose Cytarabine (LDAC)
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Full analysis set with available data at Baseline and each time point
- reporting Status
- POSTED
- time Frame
- Baseline and Day 1 of Cycles 3, 5, 7, and 9
- title
- Change From Baseline in Global Health Status / Quality of Life
- type
- SECONDARY
- unit Of Measure
- scores on a scale
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