TriangleNCT02812706 · OUTCOME
Phase 1: Plasma Concentration Observed at the End of Intravenous Infusion (Ceoi) of Isatuximab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- micrograms per milliliter
- Interval / dispersion
- Standard Deviation
- Time frame
- End of infusion on Day 1 of Cycle 1
What was measured
Ceoi is the plasma concentration observed at the end of intravenous infusion.
Analysis population: Analysis was performed on PK population that included all participants who gave their informed consent and received at least one dose (even incomplete) of Isatuximab; with data for at least 1 PK parameter available. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.
Groups in this outcome
Phase 1, Cohort 1: Isatuximab 10 mg/kg
Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).
Phase 1, Cohort 2: Isatuximab 20 mg/kg
Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).
| Group | Source count |
|---|---|
| Phase 1, Cohort 1: Isatuximab 10 mg/kg | 3 |
| Phase 1, Cohort 2: Isatuximab 20 mg/kg | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Cohort 1: Isatuximab 10 mg/kg | 122 | 21.6 | Not reported | Not reported | Not reported |
| Phase 1, Cohort 2: Isatuximab 20 mg/kg | 246 | 51.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 21.6
- value
- 122
- group Id
- OG001
- spread
- 51.8
- value
- 246
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- Ceoi is the plasma concentration observed at the end of intravenous infusion.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).
- id
- OG000
- title
- Phase 1, Cohort 1: Isatuximab 10 mg/kg
- description
- Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).
- id
- OG001
- title
- Phase 1, Cohort 2: Isatuximab 20 mg/kg
- param Type
- MEAN
- population Description
- Analysis was performed on PK population that included all participants who gave their informed consent and received at least one dose (even incomplete) of Isatuximab; with data for at least 1 PK parameter available. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.
- reporting Status
- POSTED
- time Frame
- End of infusion on Day 1 of Cycle 1
- title
- Phase 1: Plasma Concentration Observed at the End of Intravenous Infusion (Ceoi) of Isatuximab
- type
- SECONDARY
- unit Of Measure
- micrograms per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice