NCT00410605 · ADVERSE EVENTS
Adverse events
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%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Bevacizumab, Dexamethasone, and Lenalidomide | 22 / 39 | 39 / 39 | Not reported / Not reported |
Serious adverse events
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 39
- term
- Atrial fibrillation
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Atrial flutter
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Heart failure
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Left Ventricular Systolic Dysfunction
- organ System
- Endocrine disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Hypothyroidism
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Retinal Detachment
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 39
- term
- Abdominal Pain
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Colonic Perforation
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Diarrhea
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Dry Mouth
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Duodenal Hemorrhage
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Ileus
Other reported adverse events
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 39
- term
- Abdominal Pain
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 39
- term
- Alanine aminotransferase increased
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 39
- term
- Alkaline Phosphatase Increased
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 39
- term
- Allergic rhinitis
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 39
- term
- Anemia
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 39
- term
- Anorexia
- organ System
- Psychiatric disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 39
- term
- Anxiety
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 39
- term
- Arthralgia
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 39
- term
- Aspartate aminotransferase increased
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 39
- term
- Back pain
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 39
- term
- Blood bilirubin increased
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 39
- term
- Bone pain
Complete source fields
- event Groups
- 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
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 39
- term
- Abdominal Pain
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 39
- term
- Alanine aminotransferase increased
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 39
- term
- Alkaline Phosphatase Increased
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 39
- term
- Allergic rhinitis
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 39
- term
- Anemia
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 39
- term
- Anorexia
- organ System
- Psychiatric disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 39
- term
- Anxiety
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 39
- term
- Arthralgia
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 39
- term
- Aspartate aminotransferase increased
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 39
- term
- Back pain
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 39
- term
- Blood bilirubin increased
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 39
- term
- Bone pain
- serious Events
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 39
- term
- Atrial fibrillation
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Atrial flutter
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Heart failure
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Left Ventricular Systolic Dysfunction
- organ System
- Endocrine disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Hypothyroidism
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Retinal Detachment
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 39
- term
- Abdominal Pain
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Colonic Perforation
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Diarrhea
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Dry Mouth
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Duodenal Hemorrhage
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 39
- term
- Ileus
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Preserved source evidence · Not medical advice
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