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NCT02416206 · ADVERSE EVENTS

Adverse events

High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma · Source last updated 2023-05-18

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
Deaths were assessed up to 3 years. Adverse events were assessed up to 3 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
BeEAM

Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma BeEAM: BeEAM

48 / 6517 / 655 / 65

Group identifiers: EG000: BeEAM

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
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      65
    term
    neutropenic fever
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      65
    term
    Esophagitis

Other reported 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
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      65
    term
    peripheral neuropathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      65
    term
    hypertension
Complete source fields
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    65
    description
    Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma BeEAM: BeEAM
    id
    EG000
    other Num Affected
    17
    other Num At Risk
    65
    serious Num Affected
    48
    serious Num At Risk
    65
    title
    BeEAM
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      65
    term
    peripheral neuropathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      65
    term
    hypertension
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      65
    term
    neutropenic fever
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      65
    term
    Esophagitis
time Frame
Deaths were assessed up to 3 years. Adverse events were assessed up to 3 months

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Preserved source evidence · Not medical advice