TriangleNCT01471782 · OUTCOME
Percentage of Participants With Complete Remission in the First Two Cycles
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
- Cycles 1 and 2 (12 weeks)
What was measured
Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central laboratory. Complete remission (CR) was defined as * M1 bone marrow (bone marrow blasts \< 5%) * No evidence of circulating blasts or extra-medullary disease Complete remission includes participants with incomplete recovery of peripheral blood counts.
Analysis population: The full analysis set includes all participants who received any infusion of blinatumomab.
Groups in this outcome
Phase 1: Blinatumomab 5 µg/m²/Day
Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
Phase 1: Blinatumomab 15 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
Phase 1: Blinatumomab 30 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
Phase 1: Blinatumomab 15/30 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
Phase 1: 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 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 5 µg/m²/Day | 5 |
| Phase 1: Blinatumomab 15 µg/m²/Day | 7 |
| Phase 1: Blinatumomab 30 µg/m²/Day | 5 |
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 6 |
| Phase 1: Blinatumomab 5/15 µg/m²/Day | 26 |
| Phase 2: Blinatumomab 5/15 µg/m²/Day | 44 |
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 70 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 20.0 | Not reported | 0.5 | 71.6 | Not reported |
| Phase 1: Blinatumomab 15 µg/m²/Day | 42.9 | Not reported | 9.9 | 81.6 | Not reported |
| Phase 1: Blinatumomab 30 µg/m²/Day | 20.0 | Not reported | 0.5 | 71.6 | Not reported |
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 33.3 | Not reported | 4.3 | 77.7 | Not reported |
| Phase 1: Blinatumomab 5/15 µg/m²/Day | 50.0 | Not reported | 29.9 | 70.1 | Not reported |
| Phase 2: Blinatumomab 5/15 µg/m²/Day | 31.8 | Not reported | 18.6 | 47.6 | Not reported |
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 38.6 | Not reported | 27.2 | 51.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- 71.6
- value
- 20.0
- group Id
- OG001
- lower Limit
- 9.9
- upper Limit
- 81.6
- value
- 42.9
- group Id
- OG002
- lower Limit
- 0.5
- upper Limit
- 71.6
- value
- 20.0
- group Id
- OG003
- lower Limit
- 4.3
- upper Limit
- 77.7
- value
- 33.3
- group Id
- OG004
- lower Limit
- 29.9
- upper Limit
- 70.1
- value
- 50.0
- group Id
- OG005
- lower Limit
- 18.6
- upper Limit
- 47.6
- value
- 31.8
- group Id
- OG006
- lower Limit
- 27.2
- upper Limit
- 51.0
- value
- 38.6
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 26
- group Id
- OG005
- value
- 44
- group Id
- OG006
- value
- 70
- units
- Participants
- description
- Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central laboratory. Complete remission (CR) was defined as * M1 bone marrow (bone marrow blasts \< 5%) * No evidence of circulating blasts or extra-medullary disease Complete remission includes participants with incomplete recovery of peripheral blood counts.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 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 5 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
- id
- OG001
- title
- Phase 1: Blinatumomab 15 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
- id
- OG002
- title
- Phase 1: Blinatumomab 30 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
- id
- OG003
- title
- Phase 1: Blinatumomab 15/30 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
- OG004
- title
- Phase 1: 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
- OG005
- 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
- OG006
- title
- Phase 1+2: Blinatumomab 5/15 µg/m²/Day
- param Type
- NUMBER
- population Description
- The full analysis set includes all participants who received any infusion of blinatumomab.
- reporting Status
- POSTED
- time Frame
- Cycles 1 and 2 (12 weeks)
- title
- Percentage of Participants With Complete Remission in the First Two Cycles
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice