TriangleNCT03582033 · OUTCOME
Maximum Observed Serum Concentration (Cmax) 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
- 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 and 15
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. '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 | 21 |
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 | 21 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: SEA-BCMA 100mg | 28.5 | 32.3 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 200mg | 47.2 | 3.9 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 400mg | 134.8 | 11.6 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 800mg | 236.4 | 14.4 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 1600mg | 494.6 | 20.3 | Not reported | Not reported | Not reported |
Cycle 2
| Group | Source count |
|---|---|
| Part A: SEA-BCMA 100mg | 2 |
| Part A: SEA-BCMA 200mg | 1 |
| Part A: SEA-BCMA 400mg | 1 |
| Part A: SEA-BCMA 800mg | 6 |
| Part A: SEA-BCMA 1600mg | 16 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: SEA-BCMA 100mg | 44.9 | 3.6 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 200mg | 62.4 | NA | Not reported | Not reported | Geometric CV could not be calculated as only 1 participant was available for analysis. |
| Part A: SEA-BCMA 400mg | 213.1 | NA | Not reported | Not reported | Geometric CV could not be calculated as only 1 participant was available for analysis. |
| Part A: SEA-BCMA 800mg | 307.4 | 34.1 | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 1600mg | 746.6 | 29.7 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 32.3
- value
- 28.5
- group Id
- OG001
- spread
- 3.9
- value
- 47.2
- group Id
- OG002
- spread
- 11.6
- value
- 134.8
- group Id
- OG003
- spread
- 14.4
- value
- 236.4
- group Id
- OG004
- spread
- 20.3
- value
- 494.6
- 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
- 21
- units
- Participants
- title
- Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 3.6
- value
- 44.9
- comment
- Geometric CV could not be calculated as only 1 participant was available for analysis.
- group Id
- OG001
- spread
- NA
- value
- 62.4
- comment
- Geometric CV could not be calculated as only 1 participant was available for analysis.
- group Id
- OG002
- spread
- NA
- value
- 213.1
- group Id
- OG003
- spread
- 34.1
- value
- 307.4
- group Id
- OG004
- spread
- 29.7
- value
- 746.6
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 16
- 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
- 21
- units
- Participants
- 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 of Participants Analyzed" signifies participants evaluable for this outcome measure. '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 and 15
- title
- Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A
- type
- SECONDARY
- unit Of Measure
- Micrograms per milliliter (ug/mL)
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Preserved source evidence · Not medical advice