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NCT00432458 · ADVERSE EVENTS

Adverse events

Zoledronate With or Without Thalidomide in Treating Patients With Early Stage Multiple Myeloma · Source last updated 2012-07-04

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: Thal/ZLD

Thalidomide (Thal) + Zolendronic acid (ZLD)

3 / 3535 / 35Not reported / Not reported
Arm II: ZLD

Zoledronic acid (ZLD)

1 / 3328 / 33Not reported / Not reported

Group identifiers: EG000: Arm I: Thal/ZLD · EG001: Arm II: ZLD

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
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Vertigo
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Infection without neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Ureteral Obstruction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Cough
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Dyspnea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      2
    term
    Pulmonary

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 5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      5
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Cardiovascular
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Ischemia/Infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Sinus bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Ventricular arrhythmia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Otitis External
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Conjunctivitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      2
    term
    Vision
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      35
      num Events
      189
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      33
      num Events
      29
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Gastrointestinal disorder
Complete source fields
event Groups
  1. description
    Thalidomide (Thal) + Zolendronic acid (ZLD)
    id
    EG000
    other Num Affected
    35
    other Num At Risk
    35
    serious Num Affected
    3
    serious Num At Risk
    35
    title
    Arm I: Thal/ZLD
  2. description
    Zoledronic acid (ZLD)
    id
    EG001
    other Num Affected
    28
    other Num At Risk
    33
    serious Num Affected
    1
    serious Num At Risk
    33
    title
    Arm II: ZLD
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      5
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Cardiovascular
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Ischemia/Infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Sinus bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Ventricular arrhythmia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Otitis External
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Conjunctivitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      2
    term
    Vision
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      35
      num Events
      189
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      33
      num Events
      29
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Gastrointestinal disorder
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Vertigo
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Infection without neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Ureteral Obstruction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Cough
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Dyspnea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      2
    term
    Pulmonary

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Preserved source evidence · Not medical advice