TriangleNCT01757535 · OUTCOME
Time to Definitive Clinically Meaningful Deterioration for ≥ 2 Consecutive Visits as Measured Using the EQ-5D HRQoL Scale
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From day 1 (randomization) up to data cut off date of 15 July 2019; approximately 74 months
What was measured
Clinically meaningful deterioration was defined at least 0.10 point of deterioration from baseline for at least 2 consecutive visits for the EQ-5D Health Utility Index. 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 EQ-5D-3L is scored using the 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: The Health Related Quality of Life (HRQoL) evaluable population was defined as the ITT participants with a non-missing EQ-5D-3L score at baseline (C1D1) and at least one post-baseline visit. Results are presented for each post-baseline visit with sample size ≥ 25 in both arms. Death was censored at the date of the last HRQoL assessment visit.
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 | 225 |
| Placebo Plus Best Supportive Care | 217 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine Plus Best Supportive Care | NA | Not reported | 135.1 | NA | Not estimable because the survival curve does not drop to or below 0.5, i.e. the cumulative probability of developing clinically meaningful deterioration does not reach or exceed 50%, during the observation period |
| Placebo Plus Best Supportive Care | NA | Not reported | 122.9 | NA | Not estimable because the survival curve does not drop to or below 0.5, i.e. the cumulative probability of developing clinically meaningful deterioration does not reach or exceed 50%, during the observation period |
Source statistical analyses
- ci Lower Limit
- 0.6136
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.4231
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7522
- p Value Comment
- Stratification factors: • Age (at induction therapy): 55 to 64 years and ≥ 65 years • Prior history of MDS: yes/no • Cytogenetic risk (at induction therapy): intermediate-risk/poor-risk • Received consolidation therapy following induction: yes/no
- param Type
- Hazard Ratio (HR)
- param Value
- 0.9345
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.6136
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.4231
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7522
- p Value Comment
- Stratification factors: • Age (at induction therapy): 55 to 64 years and ≥ 65 years • Prior history of MDS: yes/no • Cytogenetic risk (at induction therapy): intermediate-risk/poor-risk • Received consolidation therapy following induction: yes/no
- param Type
- Hazard Ratio (HR)
- param Value
- 0.9345
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- comment
- Not estimable because the survival curve does not drop to or below 0.5, i.e. the cumulative probability of developing clinically meaningful deterioration does not reach or exceed 50%, during the observation period
- group Id
- OG000
- lower Limit
- 135.1
- upper Limit
- NA
- value
- NA
- comment
- Not estimable because the survival curve does not drop to or below 0.5, i.e. the cumulative probability of developing clinically meaningful deterioration does not reach or exceed 50%, during the observation period
- group Id
- OG001
- lower Limit
- 122.9
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 225
- group Id
- OG001
- value
- 217
- units
- Participants
- description
- Clinically meaningful deterioration was defined at least 0.10 point of deterioration from baseline for at least 2 consecutive visits for the EQ-5D Health Utility Index. 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 EQ-5D-3L is scored using the 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
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- The Health Related Quality of Life (HRQoL) evaluable population was defined as the ITT participants with a non-missing EQ-5D-3L score at baseline (C1D1) and at least one post-baseline visit. Results are presented for each post-baseline visit with sample size ≥ 25 in both arms. Death was censored at the date of the last HRQoL assessment visit.
- reporting Status
- POSTED
- time Frame
- From day 1 (randomization) up to data cut off date of 15 July 2019; approximately 74 months
- title
- Time to Definitive Clinically Meaningful Deterioration for ≥ 2 Consecutive Visits as Measured Using the EQ-5D HRQoL Scale
- type
- SECONDARY
- unit Of Measure
- Weeks
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Preserved source evidence · Not medical advice