TriangleNCT03582033 · OUTCOME
Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) 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*micrograms per milliliter (ug/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 and 2: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 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 14 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 Analyzed' signifies number of participants evaluable for the specified rows.
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
Cycle 1
| 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 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: SEA-BCMA 100mg | 181.3 | 20.0 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 200mg | 302.6 | 14.6 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 400mg | 977.2 | 37.0 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 800mg | 1443.2 | 23.9 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 1600mg | 3267.7 | 26.8 | Not reported | Not reported | Not reported |
Cycle 2
| Group | Source count |
|---|---|
| Part A: SEA-BCMA 100mg | 2 |
| Part A: SEA-BCMA 200mg | 2 |
| Part A: SEA-BCMA 400mg | 1 |
| Part A: SEA-BCMA 800mg | 6 |
| Part A: SEA-BCMA 1600mg | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: SEA-BCMA 100mg | 244.8 | 15.4 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 200mg | 436.0 | 10.6 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 400mg | 2216.4 | NA | Not reported | Not reported | Geometric Coefficient of variation (CV) could not be calculated as only 1 participant was available for analysis. |
| Part A: SEA-BCMA 800mg | 2387.9 | 41.4 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 1600mg | 5972.1 | 61.0 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 20.0
- value
- 181.3
- group Id
- OG001
- spread
- 14.6
- value
- 302.6
- group Id
- OG002
- spread
- 37.0
- value
- 977.2
- group Id
- OG003
- spread
- 23.9
- value
- 1443.2
- group Id
- OG004
- spread
- 26.8
- value
- 3267.7
- 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
- title
- Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 15.4
- value
- 244.8
- group Id
- OG001
- spread
- 10.6
- value
- 436.0
- comment
- Geometric Coefficient of variation (CV) could not be calculated as only 1 participant was available for analysis.
- group Id
- OG002
- spread
- NA
- value
- 2216.4
- group Id
- OG003
- spread
- 41.4
- value
- 2387.9
- group Id
- OG004
- spread
- 61.0
- value
- 5972.1
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 12
- units
- Participants
- title
- Cycle 2
- 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 14 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. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
- reporting Status
- POSTED
- time Frame
- Cycle 1 and 2: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1
- title
- Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A
- type
- SECONDARY
- unit Of Measure
- Day*micrograms per milliliter (ug/mL)
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Preserved source evidence · Not medical advice