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NCT06504524 · ADVERSE EVENTS

Adverse events

A Study to Compare the Effects of Elranatamab (PF 06863135) Versus Standard of Care (SOC) in Patients With Multiple Myeloma (MM) in Germany and US · Source last updated 2025-06-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All-cause mortality: During follow-up duration of approximately 25.08 months for C1071003, 50.64 months for RWD: TM-MM database and 77.4 months for RWD: Flatiron Health database; available retrospective data was evaluated in this observational study for approximately 9 months; for adverse events it was not applicable as adverse event data was not planned to be evaluated
Other-event reporting threshold
0%

This study is retrospective and observational in nature, it involves data that exist as structured data by the time of study start. The minimum criteria for reporting an adverse event (AE) (i.e., identifiable participant, identifiable reporter, a suspect product, and event) cannot be met. Hence, adverse events were not planned to be evaluated and explains 0 at risk.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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.

0 / 00 / 054 / 118
RWD: TM-MM Database

Eligible participants with TCR-MM who initiated SOC treatment and were identified from TM-MM database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.

0 / 00 / 0128 / 277
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.

0 / 00 / 0150 / 238

Group identifiers: EG000: C1071003 Cohort A · EG001: RWD: TM-MM Database · EG002: RWD: Flatiron Health Database

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      description
      This study is retrospective and observational in nature, it involves data that exist as structured data by the time of study start. The minimum criteria for reporting an adverse event (AE) (i.e., identifiable participant, identifiable reporter, a suspect product, and event) cannot be met. Hence, adverse events were not planned to be evaluated and explains 0 at risk.
      event Groups
      1. deaths Num Affected
        54
        deaths Num At Risk
        118
        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
        EG000
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        title
        C1071003 Cohort A
      2. deaths Num Affected
        128
        deaths Num At Risk
        277
        description
        Eligible participants with TCR-MM who initiated SOC treatment and were identified from TM-MM database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        title
        RWD: TM-MM Database
      3. deaths Num Affected
        150
        deaths Num At Risk
        238
        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
        EG002
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        title
        RWD: Flatiron Health Database
      frequency Threshold
      0
      time Frame
      All-cause mortality: During follow-up duration of approximately 25.08 months for C1071003, 50.64 months for RWD: TM-MM database and 77.4 months for RWD: Flatiron Health database; available retrospective data was evaluated in this observational study for approximately 9 months; for adverse events it was not applicable as adverse event data was not planned to be evaluated

      Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

      Preserved source evidence · Not medical advice