TriangleNCT01471782 · OUTCOME
Time to Hematological Relapse (Duration of 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 12 January 2015; median observation time was 23.5 months for phase 1 and 11.5 months for phase 2.
What was measured
Time to hematological relapse was measured only for participants in remission and was measured from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming 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. Hematological relapse is defined as the proportion of blasts in bone marrow \> 25% following documented remission, or extramedullary relapse. Time to hematological relapse was analyzed by Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method.
Analysis population: Full analysis set with complete remission
Groups in this outcome
Phase 1: Blinatumomab
Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
Phase 2: Blinatumomab 5/15 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
Phase 1+2: Blinatumomab 5/15 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
| Group | Source count |
|---|---|
| Phase 1: Blinatumomab | 21 |
| Phase 2: Blinatumomab 5/15 µg/m²/Day | 14 |
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 27 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Blinatumomab | 10.3 | Not reported | 3.9 | 16.4 | Not reported |
| Phase 2: Blinatumomab 5/15 µg/m²/Day | 3.4 | Not reported | 1.7 | NA | Could not be estimated due to the low number of events |
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 5.2 | Not reported | 2.3 | 16.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.9
- upper Limit
- 16.4
- value
- 10.3
- comment
- Could not be estimated due to the low number of events
- group Id
- OG001
- lower Limit
- 1.7
- upper Limit
- NA
- value
- 3.4
- group Id
- OG002
- lower Limit
- 2.3
- upper Limit
- 16.4
- value
- 5.2
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 27
- units
- Participants
- description
- Time to hematological relapse was measured only for participants in remission and was measured from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming 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. Hematological relapse is defined as the proportion of blasts in bone marrow \> 25% following documented remission, or extramedullary relapse. Time to hematological relapse was analyzed by Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
- id
- OG000
- title
- Phase 1: Blinatumomab
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
- id
- OG001
- title
- Phase 2: Blinatumomab 5/15 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
- id
- OG002
- title
- Phase 1+2: Blinatumomab 5/15 µg/m²/Day
- param Type
- MEDIAN
- population Description
- Full analysis set with complete remission
- reporting Status
- POSTED
- time Frame
- Up to the data cut-off date of 12 January 2015; median observation time was 23.5 months for phase 1 and 11.5 months for phase 2.
- title
- Time to Hematological Relapse (Duration of Response)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice