NCT00818961 · 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 |
|---|---|---|---|
| Hematopoietic Stem Cell Transplantation | 10 / 36 | 36 / 36 | Not reported / Not reported |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- Syncopal Episode
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- Thrombotic thrombocytopenic purpura
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- Arthritis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- cerebral venous thrombosis and hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- aortic valve endocarditis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- pulmonary/upper respiratory chest pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- progressive non-oliguric renal failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- pneumonia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- norovirus
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- thrombosis/embolism
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 36
- num Events
- 12
- term
- abdominal cramping
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 36
- num Events
- 9
- term
- abdominal discomfort/tenderness
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 36
- num Events
- 2
- term
- abdominal distention
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 36
- num Events
- 16
- term
- abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 36
- num Events
- 2
- term
- aggitation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 22
- num At Risk
- 36
- num Events
- 22
- term
- Alkaline Phosphatase
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Hepatobiliary disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 36
- num Events
- 26
- term
- ALT
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 36
- num Events
- 2
- term
- anal/rectal erythema
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 36
- num Events
- 29
- term
- ANC
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 27
- num At Risk
- 36
- num Events
- 27
- term
- anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 36
- num Events
- 7
- term
- ankle pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 36
- num Events
- 15
- term
- anorexia
Complete source fields
- event Groups
- description
- All patients received a hematopoietic Stem Cell Transplantation as part of this clinical trial.
- id
- EG000
- other Num Affected
- 36
- other Num At Risk
- 36
- serious Num Affected
- 10
- serious Num At Risk
- 36
- title
- Hematopoietic Stem Cell Transplantation
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 36
- num Events
- 12
- term
- abdominal cramping
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 36
- num Events
- 9
- term
- abdominal discomfort/tenderness
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 36
- num Events
- 2
- term
- abdominal distention
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 36
- num Events
- 16
- term
- abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 36
- num Events
- 2
- term
- aggitation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 22
- num At Risk
- 36
- num Events
- 22
- term
- Alkaline Phosphatase
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Hepatobiliary disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 36
- num Events
- 26
- term
- ALT
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 36
- num Events
- 2
- term
- anal/rectal erythema
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 36
- num Events
- 29
- term
- ANC
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 27
- num At Risk
- 36
- num Events
- 27
- term
- anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 36
- num Events
- 7
- term
- ankle pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 36
- num Events
- 15
- term
- anorexia
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- Syncopal Episode
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- Thrombotic thrombocytopenic purpura
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- Arthritis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- cerebral venous thrombosis and hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- aortic valve endocarditis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- pulmonary/upper respiratory chest pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- progressive non-oliguric renal failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- pneumonia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- norovirus
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 36
- num Events
- 1
- term
- thrombosis/embolism
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