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NCT00083382 · ADVERSE EVENTS

Adverse events

Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide · Source last updated 2015-06-24

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
Thalidomide + Bisphosphonate

200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy

16 / 8383 / 83Not reported / Not reported

Group identifiers: EG000: Thalidomide + Bisphosphonate

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
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      83
    term
    Pneumonitis/infiltrates
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      83
    term
    Cardiovascular-other
  3. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    Joint, muscle, bone-other
  4. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    Lung-other
  5. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      83
    term
    Respiratory infect w/o neutrop
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    Diarrhea without colostomy
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    Fatigue/malaise/lethargy
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    Syncope
  9. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    Confusion
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    Speech impairment
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    dyspnea
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    GI-other

Other reported adverse events

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

  1. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      83
    term
    Grade 1 Allergic rhinitis
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      83
    term
    Grade 1 Anemia
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      83
    term
    Grade 2 Anemia
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      83
    term
    Grade 1 Neutropenia/granulocytopenia
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      83
    term
    Grade 2 Neutropenia/granulocytopenia
  6. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      83
    term
    Grade 1 Thrombocytopenia
  7. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      83
    term
    Grade 2 Thrombocytopenia
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      83
    term
    Grade 3 Thrombocytopenia
  9. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      83
    term
    Grade 2 Leukopenia
  10. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      83
    term
    Grade 1 Arrhythmia, NOS
  11. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      83
    term
    Grade 4 Cardiovascular - other
  12. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      83
    term
    Grade 1 Edema
Complete source fields
event Groups
  1. description
    200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
    id
    EG000
    other Num Affected
    83
    other Num At Risk
    83
    serious Num Affected
    16
    serious Num At Risk
    83
    title
    Thalidomide + Bisphosphonate
frequency Threshold
5
other Events
  1. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      83
    term
    Grade 1 Allergic rhinitis
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      83
    term
    Grade 1 Anemia
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      83
    term
    Grade 2 Anemia
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      83
    term
    Grade 1 Neutropenia/granulocytopenia
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      83
    term
    Grade 2 Neutropenia/granulocytopenia
  6. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      83
    term
    Grade 1 Thrombocytopenia
  7. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      83
    term
    Grade 2 Thrombocytopenia
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      83
    term
    Grade 3 Thrombocytopenia
  9. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      83
    term
    Grade 2 Leukopenia
  10. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      83
    term
    Grade 1 Arrhythmia, NOS
  11. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      83
    term
    Grade 4 Cardiovascular - other
  12. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      83
    term
    Grade 1 Edema
serious Events
  1. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      83
    term
    Pneumonitis/infiltrates
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      83
    term
    Cardiovascular-other
  3. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    Joint, muscle, bone-other
  4. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    Lung-other
  5. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      83
    term
    Respiratory infect w/o neutrop
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    Diarrhea without colostomy
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    Fatigue/malaise/lethargy
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    Syncope
  9. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    Confusion
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    Speech impairment
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    dyspnea
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    term
    GI-other

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Preserved source evidence · Not medical advice