TriangleNCT01566695 · OUTCOME
Percentage of Participants With an Erythroid Hematological Improvement (HI-E) Response According to 2006 IWG Criteria
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
Erythroid HI-E improvement was defined as a hemoglobin increase of ≥ 1.5 g/dL; or a reduction in units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a hemoglobin of ≤ 9.0 g/dL on treatment were counted in the RBC transfusion response evaluation.
Analysis population: The ITT population included 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
HI-E Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine and Best Supportive Care | 43.0 | Not reported | 33.6 | 52.4 | Not reported |
| Placebo Plus Best Supportive Care | 32.1 | Not reported | 23.3 | 40.9 | Not reported |
≥ 1.5 g/dL Hemoglobin Increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine and Best Supportive Care | 23.4 | Not reported | 15.3 | 31.4 | Not reported |
| Placebo Plus Best Supportive Care | 5.5 | Not reported | 1.2 | 9.8 | Not reported |
RBC Transfusion Reduction
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine and Best Supportive Care | 42.1 | Not reported | 32.7 | 51.4 | Not reported |
| Placebo Plus Best Supportive Care | 31.2 | Not reported | 22.5 | 39.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- -2.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 23.7
- group Ids
- OG000
- OG001
- non Inferiority Comment
- HI-E
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1467
- param Type
- Rate Difference
- param Value
- 10.9
- statistical Comment
- Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2
- statistical Method
- Stratified Mantel-Haenszel. Chi-squared
- ci Lower Limit
- 8.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 26.9
- group Ids
- OG000
- OG001
- non Inferiority Comment
- ≥ 1.5 g/dL Hemoglobin Increase
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- param Type
- Rate Diffrence
- param Value
- 17.9
- statistical Comment
- Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2
- statistical Method
- Stratified Mantel-Haenszel. Chi-squared
- ci Lower Limit
- -1.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 23.6
- group Ids
- OG000
- OG001
- non Inferiority Comment
- RBC Transfusion Reduction
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1431
- param Type
- Rate Difference
- param Value
- 10.9
- statistical Comment
- Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2
- statistical Method
- Stratified Mantel-Haenszel. Chi-squared
Complete source fields
- analyses
- ci Lower Limit
- -2.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 23.7
- group Ids
- OG000
- OG001
- non Inferiority Comment
- HI-E
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1467
- param Type
- Rate Difference
- param Value
- 10.9
- statistical Comment
- Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2
- statistical Method
- Stratified Mantel-Haenszel. Chi-squared
- ci Lower Limit
- 8.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 26.9
- group Ids
- OG000
- OG001
- non Inferiority Comment
- ≥ 1.5 g/dL Hemoglobin Increase
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- param Type
- Rate Diffrence
- param Value
- 17.9
- statistical Comment
- Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2
- statistical Method
- Stratified Mantel-Haenszel. Chi-squared
- ci Lower Limit
- -1.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 23.6
- group Ids
- OG000
- OG001
- non Inferiority Comment
- RBC Transfusion Reduction
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1431
- param Type
- Rate Difference
- param Value
- 10.9
- statistical Comment
- Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2
- statistical Method
- Stratified Mantel-Haenszel. Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 33.6
- upper Limit
- 52.4
- value
- 43.0
- group Id
- OG001
- lower Limit
- 23.3
- upper Limit
- 40.9
- value
- 32.1
- title
- HI-E Response
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.3
- upper Limit
- 31.4
- value
- 23.4
- group Id
- OG001
- lower Limit
- 1.2
- upper Limit
- 9.8
- value
- 5.5
- title
- ≥ 1.5 g/dL Hemoglobin Increase
- categories
- measurements
- group Id
- OG000
- lower Limit
- 32.7
- upper Limit
- 51.4
- value
- 42.1
- group Id
- OG001
- lower Limit
- 22.5
- upper Limit
- 39.9
- value
- 31.2
- title
- RBC Transfusion Reduction
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 109
- units
- Participants
- description
- Erythroid HI-E improvement was defined as a hemoglobin increase of ≥ 1.5 g/dL; or a reduction in units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a hemoglobin of ≤ 9.0 g/dL on treatment were counted in the RBC transfusion response evaluation.
- 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 included 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 With an Erythroid Hematological Improvement (HI-E) Response According to 2006 IWG Criteria
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice