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NCT05932290 · ADVERSE EVENTS

Adverse events

A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma · Source last updated 2024-10-29

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 observation period of approximately 15 months for C1071003, 64.3 months for RWD: COTA and 66.9 months for RWD: Flatiron Health; Serious adverse events and other adverse events: not applicable as adverse event data was not collected.
Other-event reporting threshold
0%

This study is retrospective, it involves data that exist as structured data by the time of study start. From data source, individual participant data were not retrieved or validated. 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 collected and are not reported.

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

0 / 00 / 055 / 123
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.

0 / 00 / 0171 / 239
RWD: Flatiron Health

Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from Flatiron Health database were included. This arm served as external control arm.

0 / 00 / 090 / 152

Group identifiers: EG000: C1071003 Cohort A · EG001: RWD: COTA · EG002: RWD: Flatiron Health

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, it involves data that exist as structured data by the time of study start. From data source, individual participant data were not retrieved or validated. 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 collected and are not reported.
      event Groups
      1. deaths Num Affected
        55
        deaths Num At Risk
        123
        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
        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
        171
        deaths Num At Risk
        239
        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
        EG001
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        title
        RWD: COTA
      3. deaths Num Affected
        90
        deaths Num At Risk
        152
        description
        Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from Flatiron Health database 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
      frequency Threshold
      0
      time Frame
      All-cause mortality: During observation period of approximately 15 months for C1071003, 64.3 months for RWD: COTA and 66.9 months for RWD: Flatiron Health; Serious adverse events and other adverse events: not applicable as adverse event data was not collected.

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

      Preserved source evidence · Not medical advice