Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00396383 · ADVERSE EVENTS

Adverse events

Treatment With AMD3100 (Plerixafor) in MM Patients to Mobilize PBCs For Collection and for Transplantation · Source last updated 2014-03-13

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
The first day of plerixafor administration up to the day prior to chemotherapy/ablative treatment.
Other-event reporting threshold
0%

In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes events, regardless of reported relationship to study treatment or grade.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Participants With Multiple Myeloma (MM)

Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.

0 / 99 / 9Not reported / Not reported

Group identifiers: EG000: Participants With Multiple Myeloma (MM)

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
      Blood and lymphatic system disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Anaemia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Abdominal distension
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Diarrhoea
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Nausea
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        9
      term
      Paraesthesia oral
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Vomiting
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Catheter site erythema
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Catheter site related reaction
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Infusion site bruising
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        9
      term
      Injection site erythema
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Oedema peripheral
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Pain
    Complete source fields
    description
    In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes events, regardless of reported relationship to study treatment or grade.
    event Groups
    1. description
      Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
      id
      EG000
      other Num Affected
      9
      other Num At Risk
      9
      serious Num Affected
      0
      serious Num At Risk
      9
      title
      Participants With Multiple Myeloma (MM)
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Anaemia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Abdominal distension
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Diarrhoea
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Nausea
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        9
      term
      Paraesthesia oral
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Vomiting
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Catheter site erythema
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Catheter site related reaction
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Infusion site bruising
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        9
      term
      Injection site erythema
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Oedema peripheral
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 10.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        9
      term
      Pain
    time Frame
    The first day of plerixafor administration up to the day prior to chemotherapy/ablative treatment.

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

    Preserved source evidence · Not medical advice