TriangleNCT01564784 · OUTCOME
Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Day 1 of each cycle prior to dosing and EoT
What was measured
The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).
Analysis population: ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population.
Groups in this outcome
Inotuzumab Ozogamicin
Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\^2 (for a total cycle dose of 1.5 mg/m\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
Defined Investigator's Choice of Chemotherapy
Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
| Group | Source count |
|---|---|
| Inotuzumab Ozogamicin | 164 |
| Defined Investigator's Choice of Chemotherapy | 162 |
Reported measurements
Cycle 2, Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Inotuzumab Ozogamicin | 0.00 | 0.02 | Not reported | Not reported | Not reported |
| Defined Investigator's Choice of Chemotherapy | 0.02 | 0.03 | Not reported | Not reported | Not reported |
Cycle 3, Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Inotuzumab Ozogamicin | 0.01 | 0.02 | Not reported | Not reported | Not reported |
| Defined Investigator's Choice of Chemotherapy | -0.08 | 0.08 | Not reported | Not reported | Not reported |
Cycle 4, Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Inotuzumab Ozogamicin | 0.04 | 0.03 | Not reported | Not reported | Not reported |
| Defined Investigator's Choice of Chemotherapy | 0.00 | NA | Not reported | Not reported | n=1 |
Cycle 5, Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Inotuzumab Ozogamicin | 0.04 | 0.04 | Not reported | Not reported | Not reported |
| Defined Investigator's Choice of Chemotherapy | NA | NA | Not reported | Not reported | n=0 |
Cycle 6, Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Inotuzumab Ozogamicin | 0.03 | 0.04 | Not reported | Not reported | Not reported |
| Defined Investigator's Choice of Chemotherapy | NA | NA | Not reported | Not reported | n=0 |
EoT
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Inotuzumab Ozogamicin | -0.01 | 0.02 | Not reported | Not reported | Not reported |
| Defined Investigator's Choice of Chemotherapy | -0.04 | 0.02 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.01
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.07
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1710
- param Type
- Mean Difference (Net)
- param Value
- 0.03
- statistical Comment
- Treatment, time, treatment-by-time interaction, and baseline included as covariate.
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Lower Limit
- -0.01
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.07
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1710
- param Type
- Mean Difference (Net)
- param Value
- 0.03
- statistical Comment
- Treatment, time, treatment-by-time interaction, and baseline included as covariate.
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.02
- value
- 0.00
- group Id
- OG001
- spread
- 0.03
- value
- 0.02
- title
- Cycle 2, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.02
- value
- 0.01
- group Id
- OG001
- spread
- 0.08
- value
- -0.08
- title
- Cycle 3, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.03
- value
- 0.04
- comment
- n=1
- group Id
- OG001
- spread
- NA
- value
- 0.00
- title
- Cycle 4, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.04
- value
- 0.04
- comment
- n=0
- group Id
- OG001
- spread
- NA
- value
- NA
- title
- Cycle 5, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.04
- value
- 0.03
- comment
- n=0
- group Id
- OG001
- spread
- NA
- value
- NA
- title
- Cycle 6, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.02
- value
- -0.01
- group Id
- OG001
- spread
- 0.02
- value
- -0.04
- title
- EoT
- denoms
- counts
- group Id
- OG000
- value
- 164
- group Id
- OG001
- value
- 162
- units
- Participants
- description
- The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).
- dispersion Type
- Standard Error
- groups
- description
- Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\^2 (for a total cycle dose of 1.5 mg/m\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
- id
- OG000
- title
- Inotuzumab Ozogamicin
- description
- Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
- id
- OG001
- title
- Defined Investigator's Choice of Chemotherapy
- param Type
- MEAN
- population Description
- ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population.
- reporting Status
- POSTED
- time Frame
- Day 1 of each cycle prior to dosing and EoT
- title
- Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice