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NCT00410605 · ADVERSE EVENTS

Adverse events

Bevacizumab, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Stage II or III Multiple Myeloma · Source last updated 2017-09-01

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
Bevacizumab, Dexamethasone, and Lenalidomide

Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV lenalidomide: Given orally dexamethasone: Given orally

22 / 3939 / 39Not reported / Not reported

Group identifiers: EG000: Bevacizumab, Dexamethasone, and Lenalidomide

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
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    term
    Atrial fibrillation
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Atrial flutter
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Heart failure
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Left Ventricular Systolic Dysfunction
  5. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Hypothyroidism
  6. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Retinal Detachment
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    term
    Abdominal Pain
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Colonic Perforation
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Diarrhea
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Dry Mouth
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Duodenal Hemorrhage
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Ileus

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    term
    Abdominal Pain
  2. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      39
    term
    Alanine aminotransferase increased
  3. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      39
    term
    Alkaline Phosphatase Increased
  4. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    term
    Allergic rhinitis
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      39
    term
    Anemia
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      39
    term
    Anorexia
  7. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      39
    term
    Anxiety
  8. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      39
    term
    Arthralgia
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    term
    Aspartate aminotransferase increased
  10. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      39
    term
    Back pain
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    term
    Blood bilirubin increased
  12. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      39
    term
    Bone pain
Complete source fields
event Groups
  1. description
    Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV lenalidomide: Given orally dexamethasone: Given orally
    id
    EG000
    other Num Affected
    39
    other Num At Risk
    39
    serious Num Affected
    22
    serious Num At Risk
    39
    title
    Bevacizumab, Dexamethasone, and Lenalidomide
frequency Threshold
5
other Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    term
    Abdominal Pain
  2. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      39
    term
    Alanine aminotransferase increased
  3. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      39
    term
    Alkaline Phosphatase Increased
  4. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    term
    Allergic rhinitis
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      39
    term
    Anemia
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      39
    term
    Anorexia
  7. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      39
    term
    Anxiety
  8. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      39
    term
    Arthralgia
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    term
    Aspartate aminotransferase increased
  10. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      39
    term
    Back pain
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    term
    Blood bilirubin increased
  12. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      39
    term
    Bone pain
serious Events
  1. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    term
    Atrial fibrillation
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Atrial flutter
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Heart failure
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Left Ventricular Systolic Dysfunction
  5. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Hypothyroidism
  6. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Retinal Detachment
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    term
    Abdominal Pain
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Colonic Perforation
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Diarrhea
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Dry Mouth
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Duodenal Hemorrhage
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Ileus

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Preserved source evidence · Not medical advice