NCT05228470 · OUTCOME
Time-to-Response (TTR) as Per IMWG Criteria by BICR
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurs first (approximately up to 16 months)
What was measured
TTR was defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that was subsequently confirmed.
Analysis population: Safety analysis set included all enrolled participants who received at least 1 dose of study intervention. 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 | 3 |
| Phase 2 | 16 |
| Phase 1b + Phase 2 | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b | 2.04 | Not reported | 1.15 | 4.73 | Not reported |
| Phase 2 | 1.45 | Not reported | 0.95 | 5.52 | Not reported |
| Phase 1b + Phase 2 | 1.51 | Not reported | 0.95 | 5.52 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.15
- upper Limit
- 4.73
- value
- 2.04
- group Id
- OG001
- lower Limit
- 0.95
- upper Limit
- 5.52
- value
- 1.45
- group Id
- OG002
- lower Limit
- 0.95
- upper Limit
- 5.52
- value
- 1.51
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 19
- units
- Participants
- description
- TTR was defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that was subsequently confirmed.
- 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
- Safety analysis set included all enrolled participants who received at least 1 dose of study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure
- reporting Status
- POSTED
- time Frame
- From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurs first (approximately up to 16 months)
- title
- Time-to-Response (TTR) as Per IMWG Criteria by BICR
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice
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