TriangleNCT02907359 · OUTCOME
Number of Red Blood Cell (RBC) and Platelet Transfusions
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units of transfused RBC or platelet
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to 6 months
What was measured
The total number of RBCs transfused or, separately, the total number of platelets transfused up to the 6-month time point for each participant was counted from the date of randomization to Day 180, the date of last contact, or date of death, whichever occurred earlier. One RBC or platelet transfusion was defined as one unit, and a single bag of RBCs or platelets was considered one unit. The mean total number of RBC or platelet units transfused per participant is presented.
Analysis population: The Efficacy Analysis Set included all participants randomly assigned to the study treatment.
Groups in this outcome
Guadecitabine
Participants received Guadecitabine 60 mg/m\^2, SC, on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles).
Treatment Choice
Participants received one of the three treatment choice options: 1. LDAC 20 mg/m\^2 SC/IV once daily for 14 days of each 28-day cycles for at least 4 cycles in absence of disease progression or unacceptable toxicity.Participants who were responding or had stable disease were to continue treatment as per standard institutional practice. 2. Standard IC of a 7+3 regimen:Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and anthracycline(daunorubicin(45-60 mg)/idarubicin(9-12 mg)/mitoxantrone(8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles. 3. BSC as needed during the treatment included,but was not limited to,blood transfusions(RBCs or platelets),growth factors including erythropoiesis stimulating agents,granulocyte stimulating factors,iron chelating therapy,and broad-spectrum antibiotics and/or antifungals. Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.
| Group | Source count |
|---|---|
| Guadecitabine | 277 |
| Treatment Choice | 140 |
Reported measurements
RBC Transfusions
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Guadecitabine | 18.9 | 13.94 | Not reported | Not reported | Not reported |
| Treatment Choice | 15.0 | 13.53 | Not reported | Not reported | Not reported |
Platelet Transfusions
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Guadecitabine | 16.8 | 18.64 | Not reported | Not reported | Not reported |
| Treatment Choice | 12.1 | 20.15 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 13.94
- value
- 18.9
- group Id
- OG001
- spread
- 13.53
- value
- 15.0
- title
- RBC Transfusions
- categories
- measurements
- group Id
- OG000
- spread
- 18.64
- value
- 16.8
- group Id
- OG001
- spread
- 20.15
- value
- 12.1
- title
- Platelet Transfusions
- denoms
- counts
- group Id
- OG000
- value
- 277
- group Id
- OG001
- value
- 140
- units
- Participants
- description
- The total number of RBCs transfused or, separately, the total number of platelets transfused up to the 6-month time point for each participant was counted from the date of randomization to Day 180, the date of last contact, or date of death, whichever occurred earlier. One RBC or platelet transfusion was defined as one unit, and a single bag of RBCs or platelets was considered one unit. The mean total number of RBC or platelet units transfused per participant is presented.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received Guadecitabine 60 mg/m\^2, SC, on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles).
- id
- OG000
- title
- Guadecitabine
- description
- Participants received one of the three treatment choice options: 1. LDAC 20 mg/m\^2 SC/IV once daily for 14 days of each 28-day cycles for at least 4 cycles in absence of disease progression or unacceptable toxicity.Participants who were responding or had stable disease were to continue treatment as per standard institutional practice. 2. Standard IC of a 7+3 regimen:Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and anthracycline(daunorubicin(45-60 mg)/idarubicin(9-12 mg)/mitoxantrone(8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles. 3. BSC as needed during the treatment included,but was not limited to,blood transfusions(RBCs or platelets),growth factors including erythropoiesis stimulating agents,granulocyte stimulating factors,iron chelating therapy,and broad-spectrum antibiotics and/or antifungals. Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.
- id
- OG001
- title
- Treatment Choice
- param Type
- MEAN
- population Description
- The Efficacy Analysis Set included all participants randomly assigned to the study treatment.
- reporting Status
- POSTED
- time Frame
- Up to 6 months
- title
- Number of Red Blood Cell (RBC) and Platelet Transfusions
- type
- SECONDARY
- unit Of Measure
- units of transfused RBC or platelet
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Preserved source evidence · Not medical advice