TriangleNCT01566695 · OUTCOME
Percentage of Participants Who Achieved RBC Transfusion Independence for ≥ 84 Days
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
- 95% Confidence Interval
- Time frame
- From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
What was measured
RBC transfusion independence was defined as the absence of any red blood cell (RBC) transfusion during any consecutive "rolling" 84 days within the treatment period. Participants who did not receive any RBC transfusion during a consecutive rolling 84 days (i.e., day 1 to day 84, day 2 to day 85) were considered as a 84-day RBC transfusion independent responder.
Analysis population: The ITT population includes all participants who were randomized, regardless of whether they received treatment or not.
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 | 107 |
| Placebo Plus Best Supportive Care | 109 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine and Best Supportive Care | 28.0 | Not reported | 19.5 | 36.5 | Not reported |
| Placebo Plus Best Supportive Care | 6.4 | Not reported | 1.8 | 11.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 11.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 31.3
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- 2 sided
- param Type
- Rate Difference
- param Value
- 21.6
- statistical Comment
- Stratified by average baseline (BL) RBC tfx needs: ≤4 vs \>4 units of RBC per 28 days; BL platelet tfx status: dependent or ind. \&ECOG PS: 0 to 1 vs 2
- statistical Method
- Stratified Mantel-Haenszel; Chi-squared
Complete source fields
- analyses
- ci Lower Limit
- 11.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 31.3
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- 2 sided
- param Type
- Rate Difference
- param Value
- 21.6
- statistical Comment
- Stratified by average baseline (BL) RBC tfx needs: ≤4 vs \>4 units of RBC per 28 days; BL platelet tfx status: dependent or ind. \&ECOG PS: 0 to 1 vs 2
- statistical Method
- Stratified Mantel-Haenszel; Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.5
- upper Limit
- 36.5
- value
- 28.0
- group Id
- OG001
- lower Limit
- 1.8
- upper Limit
- 11.0
- value
- 6.4
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 109
- units
- Participants
- description
- RBC transfusion independence was defined as the absence of any red blood cell (RBC) transfusion during any consecutive "rolling" 84 days within the treatment period. Participants who did not receive any RBC transfusion during a consecutive rolling 84 days (i.e., day 1 to day 84, day 2 to day 85) were considered as a 84-day RBC transfusion independent responder.
- dispersion Type
- 95% Confidence Interval
- 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 ITT population includes all participants who were randomized, regardless of whether they received treatment or not.
- reporting Status
- POSTED
- time Frame
- From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
- title
- Percentage of Participants Who Achieved RBC Transfusion Independence for ≥ 84 Days
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice