TriangleNCT02990338 · OUTCOME
Pharmacokinetic Parameter: Plasma Concentration of Isatuximab at 1 Hour After End of Infusion (CEOI+1 Hour)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- mcg/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1:1 hour after End of Infusion on Day 1; Cycle 4:1 hour after End of Infusion on Day 1
What was measured
CEOI+1 hour was defined as the plasma concentration of isatuximab at 1 hour after end of infusion.
Analysis population: Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for Pd arm.
Groups in this outcome
IPd (Isatuximab + Pomalidomide + Dexamethasone)
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
| Group | Source count |
|---|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 149 |
Reported measurements
C1D1
| Group | Source count |
|---|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 140 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 171.55 | 38.299 | Not reported | Not reported | Not reported |
C4D1
| Group | Source count |
|---|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 114 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 294.96 | 57.331 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 38.299
- value
- 171.55
- denoms
- counts
- group Id
- OG000
- value
- 140
- units
- Participants
- title
- C1D1
- categories
- measurements
- group Id
- OG000
- spread
- 57.331
- value
- 294.96
- denoms
- counts
- group Id
- OG000
- value
- 114
- units
- Participants
- title
- C4D1
- denoms
- counts
- group Id
- OG000
- value
- 149
- units
- Participants
- description
- CEOI+1 hour was defined as the plasma concentration of isatuximab at 1 hour after end of infusion.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
- id
- OG000
- title
- IPd (Isatuximab + Pomalidomide + Dexamethasone)
- param Type
- GEOMETRIC_MEAN
- population Description
- Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for Pd arm.
- reporting Status
- POSTED
- time Frame
- Cycle 1:1 hour after End of Infusion on Day 1; Cycle 4:1 hour after End of Infusion on Day 1
- title
- Pharmacokinetic Parameter: Plasma Concentration of Isatuximab at 1 Hour After End of Infusion (CEOI+1 Hour)
- type
- SECONDARY
- unit Of Measure
- mcg/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice