TriangleNCT01566695 · OUTCOME
Duration of RBC Transfusion Reduction for Participants Who Achieved RBC Transfusion Reduction of at Least 4 Units of RBCs for at Least 8 Weeks
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- 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
A participant was considered as a RBC transfusion reduction responder if the participant had at least 4 units reduction in transfusion units over any consecutive 56 days period compared to the baseline transfusion units in 56 days.
Analysis population: Intent to Treat population; includes participants who achieved RBC transfusion reduction of at least 4 units for at least 8 weeks.
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 | 45 |
| Placebo Plus Best Supportive Care | 34 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine and Best Supportive Care | 10.0 | Not reported | 7.1 | 13.3 | Not reported |
| Placebo Plus Best Supportive Care | 2.3 | Not reported | 2.0 | 5.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.1
- upper Limit
- 13.3
- value
- 10.0
- group Id
- OG001
- lower Limit
- 2.0
- upper Limit
- 5.0
- value
- 2.3
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 34
- units
- Participants
- description
- A participant was considered as a RBC transfusion reduction responder if the participant had at least 4 units reduction in transfusion units over any consecutive 56 days period compared to the baseline transfusion units in 56 days.
- 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
- MEDIAN
- population Description
- Intent to Treat population; includes participants who achieved RBC transfusion reduction of at least 4 units for at least 8 weeks.
- 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
- Duration of RBC Transfusion Reduction for Participants Who Achieved RBC Transfusion Reduction of at Least 4 Units of RBCs for at Least 8 Weeks
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice