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NCT01174082 · ADVERSE EVENTS

Adverse events

Trial of ID-Specific Donor Vaccinated Lymphocyte Infusion for Patients With Myeloma Relapsing or Failing to Achieve a Complete Remission After an Allogenic Transplant · Source last updated 2018-06-01

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 5 years post start of treatment
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Recipient

KLH vaccine + DLI

0 / 11 / 11 / 1
Donor

KLH vaccine

0 / 11 / 10 / 1

Group identifiers: EG000: Recipient · EG001: Donor

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
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Diarrhea
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Infection
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Abd cramping
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Insomnia
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Dizziness
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Cough
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Fatigue
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Decreased Platelet
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Skin Rash
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Hemoptysis
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        1
      term
      Fever
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        1
      term
      Chills
    Complete source fields
    event Groups
    1. deaths Num Affected
      1
      deaths Num At Risk
      1
      description
      KLH vaccine + DLI
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      1
      serious Num Affected
      0
      serious Num At Risk
      1
      title
      Recipient
    2. deaths Num Affected
      0
      deaths Num At Risk
      1
      description
      KLH vaccine
      id
      EG001
      other Num Affected
      1
      other Num At Risk
      1
      serious Num Affected
      0
      serious Num At Risk
      1
      title
      Donor
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Diarrhea
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Infection
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Abd cramping
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Insomnia
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Dizziness
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Cough
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Fatigue
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Decreased Platelet
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Skin Rash
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Hemoptysis
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        1
      term
      Fever
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE(3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        1
      term
      Chills
    time Frame
    Up to 5 years post start of treatment

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

    Preserved source evidence · Not medical advice