TriangleNCT01471782 · OUTCOME
Relapse-free Survival
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
Relapse-free survival (RFS) was assessed for participants who achieved a complete remission during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Relapse free survival was estimated using 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 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 | 7.9 | Not reported | 3.0 | 12.4 | Not reported |
| Phase 2: Blinatumomab 5/15 µg/m²/Day | 3.4 | Not reported | 1.7 | 13.9 | Not reported |
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 4.4 | Not reported | 2.3 | 12.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.0
- upper Limit
- 12.4
- value
- 7.9
- group Id
- OG001
- lower Limit
- 1.7
- upper Limit
- 13.9
- value
- 3.4
- group Id
- OG002
- lower Limit
- 2.3
- upper Limit
- 12.1
- value
- 4.4
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 27
- units
- Participants
- description
- Relapse-free survival (RFS) was assessed for participants who achieved a complete remission during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Relapse free survival was estimated using 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 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
- Relapse-free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice