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NCT00439465 · ADVERSE EVENTS

Adverse events

Adoptive Cellular Immunotherapy Following Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma · Source last updated 2019-03-26

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
Adverse event data were collected from the start of treatment until 100 days post-treatment for all subjects. Total time of adverse event collection for the study was January 2007 through March 2010
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ex-vivo Expanded Effector Cells

Infusing IL-2 and GM-CSF post-HCST Ex-vivo expanded effector cells: This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes.

0 / 2311 / 230 / 23

Group identifiers: EG000: Ex-vivo Expanded Effector Cells

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.

    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        23
      term
      Moderate infection
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        23
      term
      Severe infection
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        23
      term
      Nausea
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        23
      term
      Vomiting
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Hepatobiliary disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        23
      term
      Increased liver function tests
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        23
      term
      anorexia
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        23
      term
      Mucositis - oral
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        23
      term
      Constipation
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        23
      term
      Fever
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        23
      term
      Tachycardia
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        23
      term
      Hypotension
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      23
      description
      Infusing IL-2 and GM-CSF post-HCST Ex-vivo expanded effector cells: This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes.
      id
      EG000
      other Num Affected
      11
      other Num At Risk
      23
      serious Num Affected
      0
      serious Num At Risk
      23
      title
      Ex-vivo Expanded Effector Cells
    frequency Threshold
    0
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        23
      term
      Moderate infection
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        23
      term
      Severe infection
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        23
      term
      Nausea
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        23
      term
      Vomiting
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Hepatobiliary disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        23
      term
      Increased liver function tests
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        23
      term
      anorexia
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        23
      term
      Mucositis - oral
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        23
      term
      Constipation
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        23
      term
      Fever
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        23
      term
      Tachycardia
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        23
      term
      Hypotension
    time Frame
    Adverse event data were collected from the start of treatment until 100 days post-treatment for all subjects. Total time of adverse event collection for the study was January 2007 through March 2010

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    Preserved source evidence · Not medical advice