TriangleNCT02000427 · OUTCOME
Duration of CR or CRh* Response
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
- Up to the data cut-off date of 20 May 2015; median observation time was 7.0 months
What was measured
Duration of response was measured for participants in remission (CR/CRh\*), and was measured from the time the participant first achieved remission until first documented relapse or death from disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of the last bone marrow assessment or the last survival follow-up visit to confirm remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.
Analysis population: Participants who received an infusion of blinatumomab and with a CR or CRh\* response during the first 2 treatment cycles.
Groups in this outcome
Blinatumomab
Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment.
| Group | Source count |
|---|---|
| Blinatumomab | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Blinatumomab | 6.7 | Not reported | 4.5 | NA | Could not be estimated due to the low number of events at the time of analysis |
Complete source fields
- classes
- categories
- measurements
- comment
- Could not be estimated due to the low number of events at the time of analysis
- group Id
- OG000
- lower Limit
- 4.5
- upper Limit
- NA
- value
- 6.7
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- description
- Duration of response was measured for participants in remission (CR/CRh\*), and was measured from the time the participant first achieved remission until first documented relapse or death from disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of the last bone marrow assessment or the last survival follow-up visit to confirm remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment.
- id
- OG000
- title
- Blinatumomab
- param Type
- MEDIAN
- population Description
- Participants who received an infusion of blinatumomab and with a CR or CRh\* response during the first 2 treatment cycles.
- reporting Status
- POSTED
- time Frame
- Up to the data cut-off date of 20 May 2015; median observation time was 7.0 months
- title
- Duration of CR or CRh* Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice