TriangleNCT01757535 · OUTCOME
Mean Change in the European Quality of Life-Five Dimensions-Three Levels (EQ-5D-3L) Score From Baseline
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 Deviation
- Time frame
- From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months
What was measured
The EQ-5D-3L is a self-administered questionnaire consisting of 5 questions, pertaining to specific health dimensions (ie, mobility, self-care, pain, usual activities, and anxiety/depression) and a health status scale. Each question has 3 levels of severity, corresponding to no problems, moderate problems and severe problems. Canadian population sample weights were used to derive health utility scores. A higher utility score represents a better health state. A clinically meaningful improvement or worsening was defined as at least 0.08 points of improvement or 0.10 points of worsening from baseline, respectively, for the EQ-5D-3L Health Utility Index. The instrument is scored using the United Kingdom (UK) index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health; -0.594 is considered 'worse than death'.
Analysis population: All treated participants with a EQ-5D-3L measurement at the end of treatment
Groups in this outcome
Oral Azacitidine Plus Best Supportive Care
Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.
Placebo Plus Best Supportive Care
Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.
| Group | Source count |
|---|---|
| Oral Azacitidine Plus Best Supportive Care | 164 |
| Placebo Plus Best Supportive Care | 150 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine Plus Best Supportive Care | -0.0416 | 0.15467 | Not reported | Not reported | Not reported |
| Placebo Plus Best Supportive Care | -0.0152 | 0.14799 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.15467
- value
- -0.0416
- group Id
- OG001
- spread
- 0.14799
- value
- -0.0152
- denoms
- counts
- group Id
- OG000
- value
- 164
- group Id
- OG001
- value
- 150
- units
- Participants
- description
- The EQ-5D-3L is a self-administered questionnaire consisting of 5 questions, pertaining to specific health dimensions (ie, mobility, self-care, pain, usual activities, and anxiety/depression) and a health status scale. Each question has 3 levels of severity, corresponding to no problems, moderate problems and severe problems. Canadian population sample weights were used to derive health utility scores. A higher utility score represents a better health state. A clinically meaningful improvement or worsening was defined as at least 0.08 points of improvement or 0.10 points of worsening from baseline, respectively, for the EQ-5D-3L Health Utility Index. The instrument is scored using the United Kingdom (UK) index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health; -0.594 is considered 'worse than death'.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.
- id
- OG000
- title
- Oral Azacitidine Plus Best Supportive Care
- description
- Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.
- id
- OG001
- title
- Placebo Plus Best Supportive Care
- param Type
- MEAN
- population Description
- All treated participants with a EQ-5D-3L measurement at the end of treatment
- reporting Status
- POSTED
- time Frame
- From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months
- title
- Mean Change in the European Quality of Life-Five Dimensions-Three Levels (EQ-5D-3L) Score From Baseline
- type
- SECONDARY
- unit Of Measure
- Units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice