NCT00644189 · 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 |
|---|---|---|---|
| Clofarabine | 15 / 50 | 50 / 50 | Not reported / Not reported |
Serious adverse events
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 50
- num Events
- 6
- term
- Anemia
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- CNS Cerebrovascular Ischemia
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- CNS Hemorrhage
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Constipation
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 50
- num Events
- 2
- term
- Death (due to disease Progression)
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 50
- num Events
- 3
- term
- Diarrhea
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 50
- num Events
- 3
- term
- Dyspnea
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Fatigue
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 50
- num Events
- 2
- term
- Febrile Neutropenia
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Fever
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Hypercalcemia
- organ System
- Vascular disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Hypotension
Other reported adverse events
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 255
- term
- Chills
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 254
- term
- Ascites
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 253
- term
- Platelets
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 253
- term
- Febrile neutropenia
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 253
- term
- Thrombotic thrombocytopenic purpura
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 252
- term
- Nausea
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 252
- term
- Vomiting
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 252
- term
- Leukocytosis
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 252
- term
- Head/headache
- organ System
- Skin and subcutaneous tissue disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 244
- term
- Rash/desquamation
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 50
- num Events
- 27
- term
- Bronchial obstruction
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 50
- num Events
- 24
- term
- Bronchial stricture
Complete source fields
- event Groups
- description
- Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
- id
- EG000
- other Num Affected
- 50
- other Num At Risk
- 50
- serious Num Affected
- 15
- serious Num At Risk
- 50
- title
- Clofarabine
- frequency Threshold
- 5
- other Events
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 255
- term
- Chills
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 254
- term
- Ascites
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 253
- term
- Platelets
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 253
- term
- Febrile neutropenia
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 253
- term
- Thrombotic thrombocytopenic purpura
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 252
- term
- Nausea
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 252
- term
- Vomiting
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 252
- term
- Leukocytosis
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 252
- term
- Head/headache
- organ System
- Skin and subcutaneous tissue disorders
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 50
- num Events
- 244
- term
- Rash/desquamation
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 50
- num Events
- 27
- term
- Bronchial obstruction
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 50
- num Events
- 24
- term
- Bronchial stricture
- serious Events
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 50
- num Events
- 6
- term
- Anemia
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- CNS Cerebrovascular Ischemia
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- CNS Hemorrhage
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Constipation
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 50
- num Events
- 2
- term
- Death (due to disease Progression)
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 50
- num Events
- 3
- term
- Diarrhea
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 50
- num Events
- 3
- term
- Dyspnea
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Fatigue
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 50
- num Events
- 2
- term
- Febrile Neutropenia
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Fever
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Hypercalcemia
- organ System
- Vascular disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Hypotension
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