NCT01207388 · OUTCOME
Change From Baseline in EuroQoL 5-Dimension (EQ-5D) Scales
Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2020-02-10
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline and the end of each treatment cycle (day 29 of each cycle) and 30 days after end of the last infusion (end of the core study, a maximum of 26 weeks).
What was measured
The EQ-5D is a self-administered questionnaire which captures 3 basic types of information: a descriptive profile (health state index) and the overall health rating using a visual analog scale. The health state index measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression on scales from no problems (score = 1), some problems (score = 2), to extreme problems (score = 3). For each dimension the mean change from baseline was calculated at the end of each treatment cycle and at the end of the core study. The maximum observed change from baseline during cycles 1 to 4 and the change from baseline at the end of the core study are reported for each dimension.
Analysis population: FAS with available data at relevant time points. For maximum change, the change from baseline was calculated using subset of FAS with available data (baseline and post-baseline) at the end of each cycle. The number analyzed are the number of subjects with available data at the time point at which maximum change from baseline was observed.
Groups in this outcome
Maximum Change From Baseline in Cycles 1 - 4
Not reported
Change From Baseline at End of Core Study
Not reported
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 |
|---|
| Maximum Change From Baseline in Cycles 1 - 4 | 112 |
|---|
| Change From Baseline at End of Core Study | 75 |
|---|
Reported measurements
Mobility
Analysis denominator · Participants
| Group | Source count |
|---|
| Maximum Change From Baseline in Cycles 1 - 4 | 14 |
|---|
| Change From Baseline at End of Core Study | 75 |
|---|
Values in units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Maximum Change From Baseline in Cycles 1 - 4 | -0.2 | 0.1 | Not reported | Not reported | Not reported |
|---|
| Change From Baseline at End of Core Study | 0.0 | 0.1 | Not reported | Not reported | Not reported |
|---|
Self-care
Analysis denominator · Participants
| Group | Source count |
|---|
| Maximum Change From Baseline in Cycles 1 - 4 | 13 |
|---|
| Change From Baseline at End of Core Study | 73 |
|---|
Values in units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Maximum Change From Baseline in Cycles 1 - 4 | -0.1 | 0.1 | Not reported | Not reported | Not reported |
|---|
| Change From Baseline at End of Core Study | 0.0 | 0.0 | Not reported | Not reported | Not reported |
|---|
Usual Activities
Analysis denominator · Participants
| Group | Source count |
|---|
| Maximum Change From Baseline in Cycles 1 - 4 | 27 |
|---|
| Change From Baseline at End of Core Study | 75 |
|---|
Values in units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Maximum Change From Baseline in Cycles 1 - 4 | -0.1 | 0.1 | Not reported | Not reported | Not reported |
|---|
| Change From Baseline at End of Core Study | -0.1 | 0.1 | Not reported | Not reported | Not reported |
|---|
Pain/Discomfort
Analysis denominator · Participants
| Group | Source count |
|---|
| Maximum Change From Baseline in Cycles 1 - 4 | 14 |
|---|
| Change From Baseline at End of Core Study | 75 |
|---|
Values in units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Maximum Change From Baseline in Cycles 1 - 4 | -0.2 | 0.2 | Not reported | Not reported | Not reported |
|---|
| Change From Baseline at End of Core Study | -0.1 | 0.1 | Not reported | Not reported | Not reported |
|---|
Anxiety/Depression
Analysis denominator · Participants
| Group | Source count |
|---|
| Maximum Change From Baseline in Cycles 1 - 4 | 56 |
|---|
| Change From Baseline at End of Core Study | 75 |
|---|
Values in units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Maximum Change From Baseline in Cycles 1 - 4 | -0.2 | 0.1 | Not reported | Not reported | Not reported |
|---|
| Change From Baseline at End of Core Study | -0.1 | 0.1 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.1
- value
- -0.2
- group Id
- OG001
- spread
- 0.1
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 75
- units
- Participants
- title
- Mobility
- categories
- measurements
- group Id
- OG000
- spread
- 0.1
- value
- -0.1
- group Id
- OG001
- spread
- 0.0
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 73
- units
- Participants
- title
- Self-care
- categories
- measurements
- group Id
- OG000
- spread
- 0.1
- value
- -0.1
- group Id
- OG001
- spread
- 0.1
- value
- -0.1
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 75
- units
- Participants
- title
- Usual Activities
- categories
- measurements
- group Id
- OG000
- spread
- 0.2
- value
- -0.2
- group Id
- OG001
- spread
- 0.1
- value
- -0.1
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 75
- units
- Participants
- title
- Pain/Discomfort
- categories
- measurements
- group Id
- OG000
- spread
- 0.1
- value
- -0.2
- group Id
- OG001
- spread
- 0.1
- value
- -0.1
- denoms
- counts
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 75
- units
- Participants
- title
- Anxiety/Depression
- denoms
- counts
- group Id
- OG000
- value
- 112
- group Id
- OG001
- value
- 75
- units
- Participants
- description
- The EQ-5D is a self-administered questionnaire which captures 3 basic types of information: a descriptive profile (health state index) and the overall health rating using a visual analog scale. The health state index measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression on scales from no problems (score = 1), some problems (score = 2), to extreme problems (score = 3). For each dimension the mean change from baseline was calculated at the end of each treatment cycle and at the end of the core study. The maximum observed change from baseline during cycles 1 to 4 and the change from baseline at the end of the core study are reported for each dimension.
- dispersion Type
- Standard Error
- groups
- id
- OG000
- title
- Maximum Change From Baseline in Cycles 1 - 4
- id
- OG001
- title
- Change From Baseline at End of Core Study
- param Type
- MEAN
- population Description
- FAS with available data at relevant time points. For maximum change, the change from baseline was calculated using subset of FAS with available data (baseline and post-baseline) at the end of each cycle. The number analyzed are the number of subjects with available data at the time point at which maximum change from baseline was observed.
- reporting Status
- POSTED
- time Frame
- Baseline and the end of each treatment cycle (day 29 of each cycle) and 30 days after end of the last infusion (end of the core study, a maximum of 26 weeks).
- title
- Change From Baseline in EuroQoL 5-Dimension (EQ-5D) Scales
- type
- SECONDARY
- unit Of Measure
- units on a scale
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