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NCT01062230 · ADVERSE EVENTS

Adverse events

Bone Effect of Bortezomib in Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2015-04-06

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
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
All Patients

All participants enrolled. Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles. Patients will undergo three 21-day cycles.

0 / 64 / 6Not reported / Not reported

Group identifiers: EG000: All Patients

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
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      hypercalcemia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      platelets
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Neuropathy
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Creatinine, Serum
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Low ANC
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Lymphopenia
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Fatigue
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Hypertension
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Back Pain
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      platelets - Thrombocytopenia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Albumin - hypoalbuminemia
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Nausea
    Complete source fields
    event Groups
    1. description
      All participants enrolled. Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles. Patients will undergo three 21-day cycles.
      id
      EG000
      other Num Affected
      4
      other Num At Risk
      6
      serious Num Affected
      0
      serious Num At Risk
      6
      title
      All Patients
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      hypercalcemia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      platelets
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Neuropathy
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Creatinine, Serum
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Low ANC
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Lymphopenia
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Fatigue
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Hypertension
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Back Pain
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      platelets - Thrombocytopenia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Albumin - hypoalbuminemia
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Nausea

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

    Preserved source evidence · Not medical advice