TriangleNCT01207388 · OUTCOME
Hematological Relapse-free Survival (RFS)
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
- 18 months, up to the data cut-off date of 05 August 2015
What was measured
Hematological RFS was measured from first dose of blinatumomab until the first assessment of documented relapse (either hematological or extramedullary), secondary leukemia, or death due to any cause. Participants without a documented relapse, or death due to any cause were censored at the time of their last hematological assessment. Participants who received chemotherapy for relapsed or persistent MRD or for any other reason after treatment with blinatumomab, or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse, or death occurred were censored at the start of chemotherapy or HSCT, respectively. Hematological relapse was defined as unequivocal detection of \> 5% leukemia cells in bone marrow as measured by cytological, microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia (whichever occurred first). The 18-month Kaplan-Meier estimate of hematological RFS is reported.
Analysis population: Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants.
Groups in this outcome
Blinatumomab
Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
| Group | Source count |
|---|---|
| Blinatumomab | 110 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Blinatumomab | 54 | Not reported | 33 | 70 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 33
- upper Limit
- 70
- value
- 54
- denoms
- counts
- group Id
- OG000
- value
- 110
- units
- Participants
- description
- Hematological RFS was measured from first dose of blinatumomab until the first assessment of documented relapse (either hematological or extramedullary), secondary leukemia, or death due to any cause. Participants without a documented relapse, or death due to any cause were censored at the time of their last hematological assessment. Participants who received chemotherapy for relapsed or persistent MRD or for any other reason after treatment with blinatumomab, or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse, or death occurred were censored at the start of chemotherapy or HSCT, respectively. Hematological relapse was defined as unequivocal detection of \> 5% leukemia cells in bone marrow as measured by cytological, microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia (whichever occurred first). The 18-month Kaplan-Meier estimate of hematological RFS is reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
- id
- OG000
- title
- Blinatumomab
- param Type
- NUMBER
- population Description
- Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants.
- reporting Status
- POSTED
- time Frame
- 18 months, up to the data cut-off date of 05 August 2015
- title
- Hematological Relapse-free Survival (RFS)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice