TriangleNCT01165996 · OUTCOME
Number of Patients With Response as Defined by IWG (International Working Group) Criteria for Myelodysplasia
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Formal assessment at week 12 for study primary end-point (hematologic improvement).
What was measured
Complete Response (CR) include less than 5% marrow blasts without evidence of dysplasia and normalization of peripheral blood counts, including a hemoglobin level of 110 g/L or more, a neutrophil count of 1.5 × 109/L or more, and a platelet count of 100 × 109/L or more. For PR, patients must demonstrate all CR criteria if abnormal before treatment except that marrow blasts should decrease by 50% or more compared with pretreatment levels, or patients may demonstrate a less-advanced MDS disease category than prior to treatment. Stable disease (SD) is defined by failure to achieve at least a partial response but no evidence of progression. Disease progression (DP) includes at least 50% decrease from maximum remission in granulocytes or platelets, reduction in hemoglobin by greater than or equal to 2g/dL, or transfusion dependence. Hematologic improvement (HI) includes hemoglobin increase by at least 1.5g/dL, reduction in transfusions, increase of platelets, increase of neutrophil count
Analysis population: All patients enrolled and that received any treatment.
Groups in this outcome
Arm I: Decitabine 0.2mg/kg
INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts \< 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm I: Decitabine 0.2mg/kg | 25 |
Reported measurements
Hematologic Improvement
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I: Decitabine 0.2mg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
Complete Remission
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I: Decitabine 0.2mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
Partial Remission
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I: Decitabine 0.2mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I: Decitabine 0.2mg/kg | 9 | Not reported | Not reported | Not reported | Not reported |
Disease Progression
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I: Decitabine 0.2mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- title
- Hematologic Improvement
- categories
- measurements
- group Id
- OG000
- value
- 4
- title
- Complete Remission
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Partial Remission
- categories
- measurements
- group Id
- OG000
- value
- 9
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 5
- title
- Disease Progression
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- description
- Complete Response (CR) include less than 5% marrow blasts without evidence of dysplasia and normalization of peripheral blood counts, including a hemoglobin level of 110 g/L or more, a neutrophil count of 1.5 × 109/L or more, and a platelet count of 100 × 109/L or more. For PR, patients must demonstrate all CR criteria if abnormal before treatment except that marrow blasts should decrease by 50% or more compared with pretreatment levels, or patients may demonstrate a less-advanced MDS disease category than prior to treatment. Stable disease (SD) is defined by failure to achieve at least a partial response but no evidence of progression. Disease progression (DP) includes at least 50% decrease from maximum remission in granulocytes or platelets, reduction in hemoglobin by greater than or equal to 2g/dL, or transfusion dependence. Hematologic improvement (HI) includes hemoglobin increase by at least 1.5g/dL, reduction in transfusions, increase of platelets, increase of neutrophil count
- groups
- description
- INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts \< 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm I: Decitabine 0.2mg/kg
- param Type
- NUMBER
- population Description
- All patients enrolled and that received any treatment.
- reporting Status
- POSTED
- time Frame
- Formal assessment at week 12 for study primary end-point (hematologic improvement).
- title
- Number of Patients With Response as Defined by IWG (International Working Group) Criteria for Myelodysplasia
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice