TriangleNCT01471782 · OUTCOME
Steady State Concentration of Blinatumomab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- pg/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycles 1 and 2 during the IV infusion on day 3 (at least 48 hours after start of infusion) and days 8, 15 and 22 (steady state) and day 29 at End of Infusion (EoI) and 2, 4, and 8 hours after EoI for ages ≥ 2 years.
What was measured
Blinatumomab serum concentrations were quantified in all patients during the first 2 treatment cycles in the phase 1 part of the study only. Blinatumomab concentrations were quantified using a validated bioassay, the lower limit of quantification was 50 pg/mL. Steady state serum concentration (Css) was presumed on day 1, approximately 5 half-lives after the start of the IV infusion. The steady state serum concentration reported is the mean of the observed concentrations collected after during cycles 1 and 2.
Analysis population: Phase 1 participants with available blinatumomab concentration data
Groups in this outcome
Phase 1: Blinatumomab 5 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day.
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.
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.
| Group | Source count |
|---|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 27 |
| Phase 1: Blinatumomab 15 µg/m²/Day | 34 |
| Phase 1: Blinatumomab 30 µg/m²/Day | 7 |
Reported measurements
Cycle 1 (N = 27, 34, 7)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 162 | 179 | Not reported | Not reported | Not reported |
| Phase 1: Blinatumomab 15 µg/m²/Day | 533 | 392 | Not reported | Not reported | Not reported |
| Phase 1: Blinatumomab 30 µg/m²/Day | 1520 | 1020 | Not reported | Not reported | Not reported |
Cycle 2 (N = 3, 13, 5)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 456 | 288 | Not reported | Not reported | Not reported |
| Phase 1: Blinatumomab 15 µg/m²/Day | 866 | 655 | Not reported | Not reported | Not reported |
| Phase 1: Blinatumomab 30 µg/m²/Day | 1150 | 701 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 179
- value
- 162
- group Id
- OG001
- spread
- 392
- value
- 533
- group Id
- OG002
- spread
- 1020
- value
- 1520
- title
- Cycle 1 (N = 27, 34, 7)
- categories
- measurements
- group Id
- OG000
- spread
- 288
- value
- 456
- group Id
- OG001
- spread
- 655
- value
- 866
- group Id
- OG002
- spread
- 701
- value
- 1150
- title
- Cycle 2 (N = 3, 13, 5)
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 34
- group Id
- OG002
- value
- 7
- units
- Participants
- description
- Blinatumomab serum concentrations were quantified in all patients during the first 2 treatment cycles in the phase 1 part of the study only. Blinatumomab concentrations were quantified using a validated bioassay, the lower limit of quantification was 50 pg/mL. Steady state serum concentration (Css) was presumed on day 1, approximately 5 half-lives after the start of the IV infusion. The steady state serum concentration reported is the mean of the observed concentrations collected after during cycles 1 and 2.
- dispersion Type
- Standard Deviation
- groups
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day.
- 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.
- 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.
- id
- OG002
- title
- Phase 1: Blinatumomab 30 µg/m²/Day
- param Type
- MEAN
- population Description
- Phase 1 participants with available blinatumomab concentration data
- reporting Status
- POSTED
- time Frame
- Cycles 1 and 2 during the IV infusion on day 3 (at least 48 hours after start of infusion) and days 8, 15 and 22 (steady state) and day 29 at End of Infusion (EoI) and 2, 4, and 8 hours after EoI for ages ≥ 2 years.
- title
- Steady State Concentration of Blinatumomab
- type
- SECONDARY
- unit Of Measure
- pg/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice