TriangleNCT03582033 · OUTCOME
Area Under the Serum Concentration-Time Curve From Time 0 to Day 7 (AUC0-7) of SEA-BCMA: Part A
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Day*ug/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
What was measured
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
Analysis population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Groups in this outcome
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
| Group | Source count |
|---|---|
| Part A: SEA-BCMA 100mg | 2 |
| Part A: SEA-BCMA 200mg | 2 |
| Part A: SEA-BCMA 400mg | 2 |
| Part A: SEA-BCMA 800mg | 7 |
| Part A: SEA-BCMA 1600mg | 22 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: SEA-BCMA 100mg | 112.6 | 17.6 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 200mg | 197.6 | 11.1 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 400mg | 626.5 | 26.3 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 800mg | 932.0 | 22.1 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 1600mg | 2064.5 | 23.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 17.6
- value
- 112.6
- group Id
- OG001
- spread
- 11.1
- value
- 197.6
- group Id
- OG002
- spread
- 26.3
- value
- 626.5
- group Id
- OG003
- spread
- 22.1
- value
- 932.0
- group Id
- OG004
- spread
- 23.4
- value
- 2064.5
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 22
- units
- Participants
- description
- Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG000
- title
- Part A: SEA-BCMA 100mg
- description
- Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG001
- title
- Part A: SEA-BCMA 200mg
- description
- Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG002
- title
- Part A: SEA-BCMA 400mg
- description
- Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG003
- title
- Part A: SEA-BCMA 800mg
- description
- Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG004
- title
- Part A: SEA-BCMA 1600mg
- param Type
- GEOMETRIC_MEAN
- population Description
- All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
- reporting Status
- POSTED
- time Frame
- Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
- title
- Area Under the Serum Concentration-Time Curve From Time 0 to Day 7 (AUC0-7) of SEA-BCMA: Part A
- type
- SECONDARY
- unit Of Measure
- Day*ug/mL
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Preserved source evidence · Not medical advice