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NCT00972959 · ADVERSE EVENTS

Adverse events

Effect of Combination of Bortezomib/Dexamethasone/Zoledronic Acid on Bone Disease in Patients With Multiple Myeloma Relapsed After 1-3 Prior Lines of Therapy · Source last updated 2014-08-05

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
Bortezomib/Dexamethasone/Zoledronic Acid

For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle. Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle. Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles

7 / 170 / 17Not reported / Not reported

Group identifiers: EG000: Bortezomib/Dexamethasone/Zoledronic Acid

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Death due to cardiopulmonary arrest
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Death due to thrombocytopenia grade IV
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    gastroenteritis
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    infection of lower respiratory
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    bacteraemia
  6. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    anemia and thrombocytopenia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Complete source fields
    event Groups
    1. description
      For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle. Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle. Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      17
      serious Num Affected
      7
      serious Num At Risk
      17
      title
      Bortezomib/Dexamethasone/Zoledronic Acid
    frequency Threshold
    0
    serious Events
    1. organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      Death due to cardiopulmonary arrest
    2. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      Death due to thrombocytopenia grade IV
    3. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      gastroenteritis
    4. organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        17
        num Events
        2
      term
      infection of lower respiratory
    5. organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      bacteraemia
    6. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      anemia and thrombocytopenia

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

    Preserved source evidence · Not medical advice