NCT03069352 · OUTCOME
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a
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
- score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline and Day 1 of Cycles 3, 5, 7, and 9
What was measured
PROMIS Fatigue SF 7a is a seven-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 7a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from Baseline) indicates improvement in fatigue; the minimum important difference used in this study was 3 points.
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) | 60 |
|---|
| 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 score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Low Dose Cytarabine (LDAC) | 1.567 | 1.855 | Not reported | Not reported | Not reported |
|---|
| Venetoclax + Low Dose Cytarabine (LDAC) | -2.940 | 1.093 | 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 score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Low Dose Cytarabine (LDAC) | -0.336 | 2.307 | Not reported | Not reported | Not reported |
|---|
| Venetoclax + Low Dose Cytarabine (LDAC) | -5.259 | 1.308 | 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 score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Low Dose Cytarabine (LDAC) | -3.818 | 2.314 | Not reported | Not reported | Not reported |
|---|
| Venetoclax + Low Dose Cytarabine (LDAC) | -4.625 | 1.354 | 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 score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Low Dose Cytarabine (LDAC) | -3.453 | 2.811 | Not reported | Not reported | Not reported |
|---|
| Venetoclax + Low Dose Cytarabine (LDAC) | -5.101 | 1.606 | 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
- -8.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.41
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.068
- 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
- -4.507
- ci Lower Limit
- -10.03
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.19
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.580
- 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
- -4.923
- ci Lower Limit
- -5.98
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.36
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.609
- 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
- -0.807
- ci Lower Limit
- -7.94
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.64
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 3.176
- 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
- -1.648
- 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
- 0.126
- 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
- -8.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.41
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.068
- 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
- -4.507
- ci Lower Limit
- -10.03
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.19
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.580
- 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
- -4.923
- ci Lower Limit
- -5.98
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.36
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.609
- 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
- -0.807
- ci Lower Limit
- -7.94
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.64
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 3.176
- 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
- -1.648
- 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
- 0.126
- 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
- 1.855
- value
- 1.567
- group Id
- OG001
- spread
- 1.093
- value
- -2.940
- 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
- 2.307
- value
- -0.336
- group Id
- OG001
- spread
- 1.308
- value
- -5.259
- 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
- 2.314
- value
- -3.818
- group Id
- OG001
- spread
- 1.354
- value
- -4.625
- 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
- 2.811
- value
- -3.453
- group Id
- OG001
- spread
- 1.606
- value
- -5.101
- 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
- 60
- group Id
- OG001
- value
- 127
- units
- Participants
- description
- PROMIS Fatigue SF 7a is a seven-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 7a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from Baseline) indicates improvement in fatigue; the minimum important difference used in this study was 3 points.
- 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 Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a
- type
- SECONDARY
- unit Of Measure
- score on a scale
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