TriangleNCT01566695 · OUTCOME
Percentage of Participants With Improved, Worsened, or No Change in the European Quality of Life-Five Dimension-Three Level in the Pain/Discomfort Dimension Responses at Cycle 6
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- From Baseline to Cycle 6 Day 1
What was measured
The EQ-5D-3L is a generic, self-administered questionnaire that consists of 5 dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has 3 levels of severity corresponding to no problems, some problems, and extreme problems. It also includes a Visual Analog Scale that recorded the respondent's self-rated health on a vertical, 0-100 scale, where 100 = Best imaginable health state and 0 = Worst imaginable health state. Distribution of the observed responses (i.e., no problems, moderate problems, severe problems, and missing) of the 5 dimensions at each visit was summarized per arm. The denominator for the percentage calculation per group was based on the number of the EQ-5D-3L evaluable population at baseline. The distribution of change in responses (i.e., improved \[by ≥1 level\], no change, worsened \[by ≥1 level\], and missing) from baseline are reported.
Analysis population: The HRQoL evaluable population was defined as participants with a EQ-5D-3L health utility at baseline and at least one post-baseline assessment visit.
Groups in this outcome
Oral Azacitidine and Best Supportive Care
Participants received 300 mg oral azacitidine tablets daily on days 1 to 21 of each 28-day treatment cycle and BSC included and was not limited to pRBC (packed red blood cell \[pRBC\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.
Placebo Plus Best Supportive Care
Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.
| Group | Source count |
|---|---|
| Oral Azacitidine and Best Supportive Care | 81 |
| Placebo Plus Best Supportive Care | 95 |
Reported measurements
Improved
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine and Best Supportive Care | 13.6 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Best Supportive Care | 8.4 | Not reported | Not reported | Not reported | Not reported |
No Change
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine and Best Supportive Care | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Best Supportive Care | 32.6 | Not reported | Not reported | Not reported | Not reported |
Worsened
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine and Best Supportive Care | 4.9 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Best Supportive Care | 10.5 | Not reported | Not reported | Not reported | Not reported |
Missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine and Best Supportive Care | 48.1 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Best Supportive Care | 48.4 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.436
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.436
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13.6
- group Id
- OG001
- value
- 8.4
- title
- Improved
- categories
- measurements
- group Id
- OG000
- value
- 33.3
- group Id
- OG001
- value
- 32.6
- title
- No Change
- categories
- measurements
- group Id
- OG000
- value
- 4.9
- group Id
- OG001
- value
- 10.5
- title
- Worsened
- categories
- measurements
- group Id
- OG000
- value
- 48.1
- group Id
- OG001
- value
- 48.4
- title
- Missing
- denoms
- counts
- group Id
- OG000
- value
- 81
- group Id
- OG001
- value
- 95
- units
- Participants
- description
- The EQ-5D-3L is a generic, self-administered questionnaire that consists of 5 dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has 3 levels of severity corresponding to no problems, some problems, and extreme problems. It also includes a Visual Analog Scale that recorded the respondent's self-rated health on a vertical, 0-100 scale, where 100 = Best imaginable health state and 0 = Worst imaginable health state. Distribution of the observed responses (i.e., no problems, moderate problems, severe problems, and missing) of the 5 dimensions at each visit was summarized per arm. The denominator for the percentage calculation per group was based on the number of the EQ-5D-3L evaluable population at baseline. The distribution of change in responses (i.e., improved \[by ≥1 level\], no change, worsened \[by ≥1 level\], and missing) from baseline are reported.
- groups
- description
- Participants received 300 mg oral azacitidine tablets daily on days 1 to 21 of each 28-day treatment cycle and BSC included and was not limited to pRBC (packed red blood cell \[pRBC\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.
- id
- OG000
- title
- Oral Azacitidine and Best Supportive Care
- description
- Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.
- id
- OG001
- title
- Placebo Plus Best Supportive Care
- param Type
- NUMBER
- population Description
- The HRQoL evaluable population was defined as participants with a EQ-5D-3L health utility at baseline and at least one post-baseline assessment visit.
- reporting Status
- POSTED
- time Frame
- From Baseline to Cycle 6 Day 1
- title
- Percentage of Participants With Improved, Worsened, or No Change in the European Quality of Life-Five Dimension-Three Level in the Pain/Discomfort Dimension Responses at Cycle 6
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice