Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00869206 · ADVERSE EVENTS

Adverse events

Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement · Source last updated 2018-11-07

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
Arm I (Zoledronic Acid Every 4 Weeks)

Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

96 / 879779 / 87941 / 879
Arm II (Zoledronic Acid Every 12 Weeks)

Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

103 / 868750 / 86842 / 868

Group identifiers: EG000: Arm I (Zoledronic Acid Every 4 Weeks) · EG001: Arm II (Zoledronic Acid Every 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 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      868
      num Events
      0
    term
    Bone marrow hypocellular
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      868
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      868
      num Events
      4
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      879
      num Events
      8
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      868
      num Events
      11
    term
    Hemoglobin decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      879
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      868
      num Events
      0
    term
    Hemolysis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      879
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      2
    term
    Arrhythmia supraventricular
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      1
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      879
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      2
    term
    Cardiac disorder
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      879
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      2
    term
    Cardiac valve disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      868
      num Events
      0
    term
    Cardiopulmonary arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      868
      num Events
      0
    term
    Conduction disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      868
      num Events
      0
    term
    Left ventricular failure

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 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      879
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      868
      num Events
      2
    term
    Blood disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      879
      num Events
      14
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      868
      num Events
      8
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      98
      num At Risk
      879
      num Events
      195
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      868
      num Events
      206
    term
    Hemoglobin decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      879
      num Events
      37
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      868
      num Events
      29
    term
    Hemolysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      879
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      1
    term
    Lymphatic disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      879
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      2
    term
    Thrombotic microangiopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      879
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      868
      num Events
      2
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      868
      num Events
      0
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      879
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      1
    term
    Atrial tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      879
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      868
      num Events
      4
    term
    Cardiac disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      879
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      1
    term
    Cardiac pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      879
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      868
      num Events
      2
    term
    Cardiac valve disease
Complete source fields
event Groups
  1. deaths Num Affected
    41
    deaths Num At Risk
    879
    description
    Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    779
    other Num At Risk
    879
    serious Num Affected
    96
    serious Num At Risk
    879
    title
    Arm I (Zoledronic Acid Every 4 Weeks)
  2. deaths Num Affected
    42
    deaths Num At Risk
    868
    description
    Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    750
    other Num At Risk
    868
    serious Num Affected
    103
    serious Num At Risk
    868
    title
    Arm II (Zoledronic Acid Every 12 Weeks)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      879
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      868
      num Events
      2
    term
    Blood disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      879
      num Events
      14
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      868
      num Events
      8
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      98
      num At Risk
      879
      num Events
      195
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      868
      num Events
      206
    term
    Hemoglobin decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      879
      num Events
      37
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      868
      num Events
      29
    term
    Hemolysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      879
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      1
    term
    Lymphatic disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      879
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      2
    term
    Thrombotic microangiopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      879
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      868
      num Events
      2
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      868
      num Events
      0
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      879
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      1
    term
    Atrial tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      879
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      868
      num Events
      4
    term
    Cardiac disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      879
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      1
    term
    Cardiac pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      879
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      868
      num Events
      2
    term
    Cardiac valve disease
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      868
      num Events
      0
    term
    Bone marrow hypocellular
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      868
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      868
      num Events
      4
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      879
      num Events
      8
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      868
      num Events
      11
    term
    Hemoglobin decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      879
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      868
      num Events
      0
    term
    Hemolysis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      879
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      2
    term
    Arrhythmia supraventricular
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      1
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      879
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      2
    term
    Cardiac disorder
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      879
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      868
      num Events
      2
    term
    Cardiac valve disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      868
      num Events
      0
    term
    Cardiopulmonary arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      868
      num Events
      0
    term
    Conduction disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      879
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      868
      num Events
      0
    term
    Left ventricular failure

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice