TriangleNCT06504524 · OUTCOME
OS: C1071003 Cohort A Versus Flatiron Health Database 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: First dose to death due to any cause or censoring whichever occurred first (max follow-up of 2.09Y); Flatiron Health Database: SOC to death due to any cause or censoring whichever occurred first (max follow-up of 6.45Y)
What was measured
OS: A) C1071003 Cohort A: OS was defined as time from the date of the first dose of elranatamab until death due to any cause. Participants were censored at loss to or end of follow-up. B) Flatiron Health Database: OS was defined as time from initiation of SOC until death due to any cause. Participants were censored at loss to follow-up or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months.
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.
Groups in this outcome
C1071003 Cohort A
Eligible participants with TCR-MM, who were BCMA naïve, who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) Cohort A were included.
RWD: Flatiron Health Database
Eligible participants with TCR-MM who initiated SOC treatment and were identified from Flatiron Health database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
| Group | Source count |
|---|---|
| C1071003 Cohort A | 118 |
| RWD: Flatiron Health Database | 238 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| C1071003 Cohort A | 14.62 | Not reported | 9.59 | NA | Upper limit of 95% CI could not be estimated due to insufficient number of participants with events. |
| RWD: Flatiron Health Database | 18.99 | Not reported | 13.14 | 24.74 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.85
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.64
- estimate Comment
- IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- =0.4429
- param Type
- Hazard Ratio (HR)
- param Value
- 1.18
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.85
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.64
- estimate Comment
- IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- =0.4429
- param Type
- Hazard Ratio (HR)
- param Value
- 1.18
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 9.59
- upper Limit
- NA
- value
- 14.62
- group Id
- OG001
- lower Limit
- 13.14
- upper Limit
- 24.74
- value
- 18.99
- denoms
- counts
- group Id
- OG000
- value
- 118
- group Id
- OG001
- value
- 238
- units
- Participants
- description
- OS: A) C1071003 Cohort A: OS was defined as time from the date of the first dose of elranatamab until death due to any cause. Participants were censored at loss to or end of follow-up. B) Flatiron Health Database: OS was defined as time from initiation of SOC until death due to any cause. Participants were censored at loss to follow-up or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Eligible participants with TCR-MM, who were BCMA naïve, who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) Cohort A were included.
- id
- OG000
- title
- C1071003 Cohort A
- description
- Eligible participants with TCR-MM who initiated SOC treatment and were identified from Flatiron Health database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
- id
- OG001
- title
- RWD: Flatiron Health Database
- 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.
- reporting Status
- POSTED
- time Frame
- C1071003: First dose to death due to any cause or censoring whichever occurred first (max follow-up of 2.09Y); Flatiron Health Database: SOC to death due to any cause or censoring whichever occurred first (max follow-up of 6.45Y)
- title
- OS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice