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NCT05565391 · ADVERSE EVENTS

Adverse events

A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma · Source last updated 2024-05-21

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
Not applicable as safety data was not collected.
Other-event reporting threshold
0%

This was a retrospective study and the data existed as structured data. In these data sources, individual participant data were not retrieved or validated, and it was not possible to link a particular product and medical event for any individual. Thus, the minimum criteria for reporting an adverse event could not be met, hence adverse events data were not collected and reported.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Study C1071003 Cohort A

Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.

0 / 00 / 00 / 0
COTA Chohort

Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.

0 / 00 / 00 / 0
Flatiron Health Cohort

Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.

0 / 00 / 00 / 0

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

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 was a retrospective study and the data existed as structured data. In these data sources, individual participant data were not retrieved or validated, and it was not possible to link a particular product and medical event for any individual. Thus, the minimum criteria for reporting an adverse event could not be met, hence adverse events data were not collected and reported.
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        0
        description
        Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        title
        Study C1071003 Cohort A
      2. deaths Num Affected
        0
        deaths Num At Risk
        0
        description
        Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        title
        COTA Chohort
      3. deaths Num Affected
        0
        deaths Num At Risk
        0
        description
        Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.
        id
        EG002
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        title
        Flatiron Health Cohort
      frequency Threshold
      0
      time Frame
      Not applicable as safety data was not collected.

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

      Preserved source evidence · Not medical advice