TriangleNCT03582033 · OUTCOME
AUC0-7 of SEA-BCMA: Part C
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. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Groups in this outcome
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Part C: SEA-BCMA 800mg and Dexamethasone
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 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 C: SEA-BCMA 1600mg and Dexamethasone | 12 |
| Part C: SEA-BCMA 800mg and Dexamethasone | 3 |
| Part C: SEA-BCMA 1600 mg and Dexamethasone | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part C: SEA-BCMA 1600mg and Dexamethasone | 2011.8 | 32.9 | Not reported | Not reported | Not reported |
| Part C: SEA-BCMA 800mg and Dexamethasone | 840.3 | 21.2 | Not reported | Not reported | Not reported |
| Part C: SEA-BCMA 1600 mg and Dexamethasone | 1629.3 | 20.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 32.9
- value
- 2011.8
- group Id
- OG001
- spread
- 21.2
- value
- 840.3
- group Id
- OG002
- spread
- 20.9
- value
- 1629.3
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- 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 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 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 C: SEA-BCMA 1600mg and Dexamethasone
- description
- Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 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 C: SEA-BCMA 800mg and Dexamethasone
- description
- Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 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 C: SEA-BCMA 1600 mg and Dexamethasone
- param Type
- GEOMETRIC_MEAN
- population Description
- All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
- 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
- AUC0-7 of SEA-BCMA: Part C
- type
- SECONDARY
- unit Of Measure
- Day*ug/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice