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NCT00171925 · ADVERSE EVENTS

Adverse events

Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I · Source last updated 2012-04-11

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
Zoledronic Acid

Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.

28 / 7261 / 72Not reported / Not reported
Control

No treatment with study medication.

12 / 7151 / 71Not reported / Not reported

Group identifiers: EG000: Zoledronic Acid · EG001: Control

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 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Aortic valve disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Arrhythmia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Cardiac amyloidosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    Cardiac disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Left ventricular failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Phimosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Goitre
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Toxic nodular goitre
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    Ileus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Condition aggravated

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
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      71
    term
    Vertigo
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      71
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Chills
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      71
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Influenza like illness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      71
    term
    Oedema peripheral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      71
    term
    Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Pyrexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      71
    term
    Bronchitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    Infection
Complete source fields
event Groups
  1. description
    Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
    id
    EG000
    other Num Affected
    61
    other Num At Risk
    72
    serious Num Affected
    28
    serious Num At Risk
    72
    title
    Zoledronic Acid
  2. description
    No treatment with study medication.
    id
    EG001
    other Num Affected
    51
    other Num At Risk
    71
    serious Num Affected
    12
    serious Num At Risk
    71
    title
    Control
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      71
    term
    Vertigo
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      71
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Chills
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      71
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Influenza like illness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      71
    term
    Oedema peripheral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      71
    term
    Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Pyrexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      71
    term
    Bronchitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    Infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Aortic valve disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Arrhythmia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Cardiac amyloidosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    Cardiac disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Left ventricular failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Phimosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Goitre
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Toxic nodular goitre
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    Ileus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.X
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    Condition aggravated

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