TriangleNCT04798586 · OUTCOME
Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurs first, or censoring date (maximum of 65.1 weeks of treatment)
What was measured
DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5g/dL\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200mg/24h\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved sFLC levels \[absolute increase \>10mg/dL\]; in participants without measurable serum, urine M-protein levels \& involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status \[absolute increase \>=10%\]; appearance of new lesion,\>=50% increase from nadir in SPD of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1cm in short axis; \>=50% increase in circulating plasma cells \[\>=200cells/μL\] if this is the only measure of disease.
Analysis population: SAS included all enrolled participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Groups in this outcome
Elranatamab
Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks).
| Group | Source count |
|---|---|
| Elranatamab | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elranatamab | 12.70 | Not reported | 10.4 | NA | Upper limit could not be estimated due to insufficient number of participants with the event. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit could not be estimated due to insufficient number of participants with the event.
- group Id
- OG000
- lower Limit
- 10.4
- upper Limit
- NA
- value
- 12.70
- denoms
- counts
- group Id
- OG000
- value
- 2
- units
- Participants
- description
- DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5g/dL\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200mg/24h\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved sFLC levels \[absolute increase \>10mg/dL\]; in participants without measurable serum, urine M-protein levels \& involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status \[absolute increase \>=10%\]; appearance of new lesion,\>=50% increase from nadir in SPD of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1cm in short axis; \>=50% increase in circulating plasma cells \[\>=200cells/μL\] if this is the only measure of disease.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks).
- id
- OG000
- title
- Elranatamab
- param Type
- MEDIAN
- population Description
- SAS included all enrolled participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurs first, or censoring date (maximum of 65.1 weeks of treatment)
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice