NCT05228470 · OUTCOME
Maximum Serum Concentration (Cmax) of Free Elranatamab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Microgram per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1: Pre-dose, 6 hours post-dose on Day 1, 24, 48 hours post-dose, Day 4: pre-dose, 24 hour post-dose, Day 8 pre-dose, 6 hours post-dose, Day 15,22: pre-dose, Cycles 2, 3 ,4,7: pre-dose (1 cycle =28 days)
Analysis population: Pharmacokinetic (PK) parameter analysis set included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single dose and/or multiple-dose PK part. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Groups in this outcome
Phase 1b
Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.
Phase 2
Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.
Phase 1b + Phase 2
Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.
| Group | Source count |
|---|---|
| Phase 1b | 7 |
| Phase 2 | 6 |
| Phase 1b + Phase 2 | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b | 0.8762 | 66 | Not reported | Not reported | Not reported |
| Phase 2 | 0.8039 | 24 | Not reported | Not reported | Not reported |
| Phase 1b + Phase 2 | 0.8420 | 48 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 66
- value
- 0.8762
- group Id
- OG001
- spread
- 24
- value
- 0.8039
- group Id
- OG002
- spread
- 48
- value
- 0.8420
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 13
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.
- id
- OG000
- title
- Phase 1b
- description
- Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.
- id
- OG001
- title
- Phase 2
- description
- Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.
- id
- OG002
- title
- Phase 1b + Phase 2
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic (PK) parameter analysis set included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single dose and/or multiple-dose PK part. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Cycle 1: Pre-dose, 6 hours post-dose on Day 1, 24, 48 hours post-dose, Day 4: pre-dose, 24 hour post-dose, Day 8 pre-dose, 6 hours post-dose, Day 15,22: pre-dose, Cycles 2, 3 ,4,7: pre-dose (1 cycle =28 days)
- title
- Maximum Serum Concentration (Cmax) of Free Elranatamab
- type
- SECONDARY
- unit Of Measure
- Microgram per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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