NCT02907359 · OUTCOME
Percentage of Participants With Transfusion Independence for Any 8 Consecutive Weeks
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
- Up to approximately 46.6 months
What was measured
Transfusion independence rate was calculated as the number of participants with neither RBC nor platelet transfusion for any period of 8 weeks after the initiation of treatment (or cycle 1 day 1 { C1D1} visit date for participants randomized to BSC or randomization date for participants not treated) and up to treatment discontinuation (or 180 days for participants discontinuing the treatment within 6 months), while maintaining haemoglobin (Hgb) ≥8 gram per deciliter (g/dL) and platelets ≥20×10\^9/liter (L) divided by the total number of participants included in the efficacy analysis. RBC or Platelet transfusion independence rate was defined similarly as above. Percentage of participants are rounded off to the single decimal point.
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
Transfusion Independence Rate (8 weeks)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Guadecitabine | 15.9 | Not reported | Not reported | Not reported | Not reported |
| Treatment Choice | 15.7 | Not reported | Not reported | Not reported | Not reported |
Platelet Transfusion Independence Rate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Guadecitabine | 32.1 | Not reported | Not reported | Not reported | Not reported |
| Treatment Choice | 37.9 | Not reported | Not reported | Not reported | Not reported |
RBC Transfusion Independence Rate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Guadecitabine | 22.4 | Not reported | Not reported | Not reported | Not reported |
| Treatment Choice | 22.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 15.9
- group Id
- OG001
- value
- 15.7
- title
- Transfusion Independence Rate (8 weeks)
- categories
- measurements
- group Id
- OG000
- value
- 32.1
- group Id
- OG001
- value
- 37.9
- title
- Platelet Transfusion Independence Rate
- categories
- measurements
- group Id
- OG000
- value
- 22.4
- group Id
- OG001
- value
- 22.0
- title
- RBC Transfusion Independence Rate
- denoms
- counts
- group Id
- OG000
- value
- 277
- group Id
- OG001
- value
- 140
- units
- Participants
- description
- Transfusion independence rate was calculated as the number of participants with neither RBC nor platelet transfusion for any period of 8 weeks after the initiation of treatment (or cycle 1 day 1 { C1D1} visit date for participants randomized to BSC or randomization date for participants not treated) and up to treatment discontinuation (or 180 days for participants discontinuing the treatment within 6 months), while maintaining haemoglobin (Hgb) ≥8 gram per deciliter (g/dL) and platelets ≥20×10\^9/liter (L) divided by the total number of participants included in the efficacy analysis. RBC or Platelet transfusion independence rate was defined similarly as above. Percentage of participants are rounded off to the single decimal point.
- 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
- NUMBER
- population Description
- The Efficacy Analysis Set included all participants randomly assigned to the study treatment.
- reporting Status
- POSTED
- time Frame
- Up to approximately 46.6 months
- title
- Percentage of Participants With Transfusion Independence for Any 8 Consecutive Weeks
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice
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