Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00622505 · ADVERSE EVENTS

Adverse events

Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants · Source last updated 2021-05-26

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 2 Years
Other-event reporting threshold
5%

Safety analysis set included all enrolled participants who received at least 1 dose of zoledronic acid. Number analyzed signifies the number of participants with data available for analysis at given time point.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Zoledronic Acid Every 12 Weeks

Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \<50 nmol/mmol creatinine).

23 / 7970 / 792 / 79
Zoledronic Acid Every 4 Weeks or 12 Weeks

Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \<50 nmol/mmol creatinine, respectively).

25 / 4241 / 422 / 42

Group identifiers: EG000: Zoledronic Acid Every 12 Weeks · EG001: Zoledronic Acid Every 4 Weeks or 12 Weeks

Serious 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 (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Pancytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Atrial flutter
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Atrioventricular block complete
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Cardiac failure congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Cardiogenic shock
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Cardiomegaly
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Coronary artery disease

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 (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      42
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      42
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Abdominal discomfort
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      42
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      42
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      42
    term
    Gastrooesophageal reflux disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      42
    term
    Nausea
Complete source fields
description
Safety analysis set included all enrolled participants who received at least 1 dose of zoledronic acid. Number analyzed signifies the number of participants with data available for analysis at given time point.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    79
    description
    Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \<50 nmol/mmol creatinine).
    id
    EG000
    other Num Affected
    70
    other Num At Risk
    79
    serious Num Affected
    23
    serious Num At Risk
    79
    title
    Zoledronic Acid Every 12 Weeks
  2. deaths Num Affected
    2
    deaths Num At Risk
    42
    description
    Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \<50 nmol/mmol creatinine, respectively).
    id
    EG001
    other Num Affected
    41
    other Num At Risk
    42
    serious Num Affected
    25
    serious Num At Risk
    42
    title
    Zoledronic Acid Every 4 Weeks or 12 Weeks
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      42
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      42
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Abdominal discomfort
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      42
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      42
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      42
    term
    Gastrooesophageal reflux disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      42
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Pancytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Atrial flutter
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Atrioventricular block complete
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Cardiac failure congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Cardiogenic shock
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Cardiomegaly
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Coronary artery disease
time Frame
Up to 2 Years

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

Preserved source evidence · Not medical advice