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NCT00437034 · ADVERSE EVENTS

Adverse events

Aflibercept for Relapsed Multiple Myeloma · Source last updated 2021-02-08

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Antiangiogenesis Therapy)

Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. aflibercept: Given IV

0 / 66 / 6Not reported / Not reported

Group identifiers: EG000: Treatment (Antiangiogenesis Therapy)

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. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        2
      term
      Cough
    2. organ System
      Vascular disorders
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        6
        num Events
        6
      term
      Hypertension
    3. organ System
      Psychiatric disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Insomnia
    4. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        6
        num Events
        4
      term
      Anemia
    5. organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Dizziness
    6. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      ODYNOPHAGIA (PAINFUL SWALLOWING)
    7. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        2
      term
      Voice changes
    8. organ System
      Skin and subcutaneous tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Rash: desquamation
    9. organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Pain: Muscle
    10. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        6
        num Events
        3
      term
      Fatigue
    11. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Diarrhea
    12. organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Leukocytes decreased
    Complete source fields
    event Groups
    1. description
      Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. aflibercept: Given IV
      id
      EG000
      other Num Affected
      6
      other Num At Risk
      6
      serious Num Affected
      0
      serious Num At Risk
      6
      title
      Treatment (Antiangiogenesis Therapy)
    frequency Threshold
    0
    other Events
    1. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        2
      term
      Cough
    2. organ System
      Vascular disorders
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        6
        num Events
        6
      term
      Hypertension
    3. organ System
      Psychiatric disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Insomnia
    4. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        6
        num Events
        4
      term
      Anemia
    5. organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Dizziness
    6. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      ODYNOPHAGIA (PAINFUL SWALLOWING)
    7. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        2
      term
      Voice changes
    8. organ System
      Skin and subcutaneous tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Rash: desquamation
    9. organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Pain: Muscle
    10. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        6
        num Events
        3
      term
      Fatigue
    11. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Diarrhea
    12. organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Leukocytes decreased

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    Preserved source evidence · Not medical advice