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NCT03490344 · ADVERSE EVENTS

Adverse events

Short Course Daratumumab in Patients With Multiple Myeloma · Source last updated 2025-05-25

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
Up to 1 year
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Participants With Multiple Myeloma

Participants with MM with very good partial response (VGPR) or better after induction therapy with/without consolidative HDT/ASCT and MRD positive by bone marrow flow cytometry and MM participants who were previously MRD negative after induction and consolidation and recently (within last 3 months) turned MRD positive by bone marrow flow cytometry will be enrolled.

3 / 100 / 103 / 10

Group identifiers: EG000: Participants With Multiple Myeloma

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    Death NOS

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
    event Groups
    1. deaths Num Affected
      3
      deaths Num At Risk
      10
      description
      Participants with MM with very good partial response (VGPR) or better after induction therapy with/without consolidative HDT/ASCT and MRD positive by bone marrow flow cytometry and MM participants who were previously MRD negative after induction and consolidation and recently (within last 3 months) turned MRD positive by bone marrow flow cytometry will be enrolled.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      10
      serious Num Affected
      3
      serious Num At Risk
      10
      title
      Participants With Multiple Myeloma
    frequency Threshold
    5
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        10
      term
      Death NOS
    time Frame
    Up to 1 year

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

    Preserved source evidence · Not medical advice