TriangleNCT05228470 · OUTCOME
Time To Maximum Serum Concentration (Tmax) of Free Elranatamab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- Full Range
- 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: 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 | 7.00 | Not reported | 3.93 | 9.97 | Not reported |
| Phase 2 | 8.00 | Not reported | 6.94 | 11.0 | Not reported |
| Phase 1b + Phase 2 | 7.00 | Not reported | 3.93 | 11.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.93
- upper Limit
- 9.97
- value
- 7.00
- group Id
- OG001
- lower Limit
- 6.94
- upper Limit
- 11.0
- value
- 8.00
- group Id
- OG002
- lower Limit
- 3.93
- upper Limit
- 11.0
- value
- 7.00
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 13
- units
- Participants
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- 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
- Time To Maximum Serum Concentration (Tmax) of Free Elranatamab
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice