TriangleNCT05932290 · OUTCOME
OS: Study C1071003 Cohort A Versus RWD COTA Cohort- Using IPTW Analysis
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
- C1071003: The date of the first dose until death due to any cause or censoring (maximum up to 15 months); COTA: First line after participant identified as having TCR MM until the date of death due to any cause or censoring (maximum of 64.3 months)
What was measured
OS: a) C1071003 Cohort A: OS was defined as time from the date of the first dose until death due to any cause; b) COTA Cohort: OS was defined as time from initiation of the first line after participant identified as having TCR MM until the date of death due to any cause. Kaplan Meier Method was used for analysis. Participants without an event were censored at the latest available record or the data cut-off.
Analysis population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects. IPTW created pseudo-sets and "Number of Participants Analyzed" are different from participant flow and baseline section.
Groups in this outcome
C1071003 Cohort A
Eligible participants with TCR MM, who were BCMA naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.
RWD: COTA
Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from COTA database were included. This arm served as external control arm.
| Group | Source count |
|---|---|
| C1071003 Cohort A | 113 |
| RWD: COTA | 235 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| C1071003 Cohort A | NA | Not reported | NA | NA | Median and 95% CI was not estimated because of insufficient number of participants with the event. |
| RWD: COTA | 11.24 | Not reported | 8.51 | 14.29 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.27
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.77
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- .0032
- param Type
- Hazard Ratio (HR)
- param Value
- 0.46
- statistical Comment
- IPTW HRs were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances.
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.27
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.77
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- .0032
- param Type
- Hazard Ratio (HR)
- param Value
- 0.46
- statistical Comment
- IPTW HRs were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances.
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- comment
- Median and 95% CI was not estimated because of insufficient number of participants with the event.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 8.51
- upper Limit
- 14.29
- value
- 11.24
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 235
- units
- Participants
- description
- OS: a) C1071003 Cohort A: OS was defined as time from the date of the first dose until death due to any cause; b) COTA Cohort: OS was defined as time from initiation of the first line after participant identified as having TCR MM until the date of death due to any cause. Kaplan Meier Method was used for analysis. Participants without an event were censored at the latest available record or the data cut-off.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Eligible participants with TCR MM, who were BCMA naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.
- id
- OG000
- title
- C1071003 Cohort A
- description
- Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from COTA database were included. This arm served as external control arm.
- id
- OG001
- title
- RWD: COTA
- param Type
- MEDIAN
- population Description
- Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects. IPTW created pseudo-sets and "Number of Participants Analyzed" are different from participant flow and baseline section.
- reporting Status
- POSTED
- time Frame
- C1071003: The date of the first dose until death due to any cause or censoring (maximum up to 15 months); COTA: First line after participant identified as having TCR MM until the date of death due to any cause or censoring (maximum of 64.3 months)
- title
- OS: Study C1071003 Cohort A Versus RWD COTA Cohort- Using IPTW Analysis
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice