TriangleNCT01466179 · OUTCOME
Serum Blinatumomab Concentration at Steady State
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
- Samples were taken before treatment start and on Days 3, 8, 10, 15, 22, and 29 after infusion start during Cycles 1 and 2.
What was measured
The steady state concentration of blinatumomab was summarized as the observed concentrations collected at least 10 hours after the start of the IV infusion or dose step for cycle 1 and cycle 2, respectively. Serum concentrations of blinatumomab were measured using a validated bioassay. The lower limit of quantitation (LLOQ) = 50.0 pg/mL.
Analysis population: Pharmacokinetic Data Set (PKS) defined as all patients who received any infusion of blinatumomab and had at least one PK sample collected unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption or sampling information was missing.
Groups in this outcome
Cycle 1: Blinatumomab 9 μg/Day
Participants receiving 9 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
Cycle 1: Blinatumomab 28 μg/Day
Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
Cycle 2: Blinatumomab 28 μg/Day
Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 2.
| Group | Source count |
|---|---|
| Cycle 1: Blinatumomab 9 μg/Day | 132 |
| Cycle 1: Blinatumomab 28 μg/Day | 160 |
| Cycle 2: Blinatumomab 28 μg/Day | 88 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cycle 1: Blinatumomab 9 μg/Day | 211 | 258 | Not reported | Not reported | Not reported |
| Cycle 1: Blinatumomab 28 μg/Day | 621 | 502 | Not reported | Not reported | Not reported |
| Cycle 2: Blinatumomab 28 μg/Day | 731 | 444 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 258
- value
- 211
- group Id
- OG001
- spread
- 502
- value
- 621
- group Id
- OG002
- spread
- 444
- value
- 731
- denoms
- counts
- group Id
- OG000
- value
- 132
- group Id
- OG001
- value
- 160
- group Id
- OG002
- value
- 88
- units
- Participants
- description
- The steady state concentration of blinatumomab was summarized as the observed concentrations collected at least 10 hours after the start of the IV infusion or dose step for cycle 1 and cycle 2, respectively. Serum concentrations of blinatumomab were measured using a validated bioassay. The lower limit of quantitation (LLOQ) = 50.0 pg/mL.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants receiving 9 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
- id
- OG000
- title
- Cycle 1: Blinatumomab 9 μg/Day
- description
- Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
- id
- OG001
- title
- Cycle 1: Blinatumomab 28 μg/Day
- description
- Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 2.
- id
- OG002
- title
- Cycle 2: Blinatumomab 28 μg/Day
- param Type
- MEAN
- population Description
- Pharmacokinetic Data Set (PKS) defined as all patients who received any infusion of blinatumomab and had at least one PK sample collected unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption or sampling information was missing.
- reporting Status
- POSTED
- time Frame
- Samples were taken before treatment start and on Days 3, 8, 10, 15, 22, and 29 after infusion start during Cycles 1 and 2.
- title
- Serum Blinatumomab Concentration at Steady State
- type
- SECONDARY
- unit Of Measure
- pg/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice