TriangleNCT02812706 · OUTCOME
Phase 1: Time to Reach the Maximum Concentration (Tmax) After First Infusion of Isatuximab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1 Day 1 at 0 hour (pre-dose), mid-infusion (2 hours post-infusion), EOI and EOI+4-hour, Day 2 (24 hour), Day 3 (48 hour), Day 4 (72 hour) and pre-dose on Day 8 (0 hour)
What was measured
Tmax was defined as the time to reach Cmax, calculated using the non-compartmental analysis after the intravenous infusion.
Analysis population: Analysis was performed on PK population. 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 | 2.68 | Not reported | 2.32 | 7.25 | Not reported |
| Phase 1, Cohort 2: Isatuximab 20 mg/kg | 5.56 | Not reported | 3.28 | 8.48 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.32
- upper Limit
- 7.25
- value
- 2.68
- group Id
- OG001
- lower Limit
- 3.28
- upper Limit
- 8.48
- value
- 5.56
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- Tmax was defined as the time to reach Cmax, calculated using the non-compartmental analysis after the intravenous infusion.
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- Analysis was performed on PK population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 at 0 hour (pre-dose), mid-infusion (2 hours post-infusion), EOI and EOI+4-hour, Day 2 (24 hour), Day 3 (48 hour), Day 4 (72 hour) and pre-dose on Day 8 (0 hour)
- title
- Phase 1: Time to Reach the Maximum Concentration (Tmax) After First Infusion of Isatuximab
- type
- SECONDARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice