TriangleNCT00481247 · 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
- Randomization to end of study (December 2015)
- Other-event reporting threshold
- 5%
Study initiated: September 2007; End of Study: December 2015
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Dasatinib | 90 / 258 | 216 / 258 | Not reported / Not reported |
| Imatinib | 70 / 258 | 231 / 258 | Not reported / Not reported |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 258
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 258
- term
- BICYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 258
- term
- BONE MARROW FAILURE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 258
- term
- FEBRILE NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 258
- term
- NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 258
- term
- PANCYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 258
- term
- THROMBOCYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (18.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 258
- term
- LEUKOCYTOSIS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (18.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 258
- term
- THROMBOCYTOSIS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 258
- term
- ACUTE MYOCARDIAL INFARCTION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 258
- term
- ANGINA UNSTABLE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 258
- term
- CARDIAC ARREST
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 38
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 31
- num At Risk
- 258
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 258
- term
- LEUKOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 60
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 49
- num At Risk
- 258
- term
- NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 59
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 48
- num At Risk
- 258
- term
- THROMBOCYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 40
- num At Risk
- 258
- term
- EYELID OEDEMA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA (18.1)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 20
- num At Risk
- 258
- term
- PERIORBITAL OEDEMA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 36
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 258
- term
- ABDOMINAL PAIN
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 22
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 258
- term
- ABDOMINAL PAIN UPPER
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 258
- term
- CONSTIPATION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 99
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 89
- num At Risk
- 258
- term
- DIARRHOEA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 22
- num At Risk
- 258
- term
- DYSPEPSIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 23
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 258
- term
- GASTRITIS
Complete source fields
- description
- Study initiated: September 2007; End of Study: December 2015
- event Groups
- description
- Tablets, oral, dasatinib 100 mg once daily (QD)
- id
- EG000
- other Num Affected
- 216
- other Num At Risk
- 258
- serious Num Affected
- 90
- serious Num At Risk
- 258
- title
- Dasatinib
- description
- Tablets, oral, imatinib 400 mg once daily (QD)
- id
- EG001
- other Num Affected
- 231
- other Num At Risk
- 258
- serious Num Affected
- 70
- serious Num At Risk
- 258
- title
- Imatinib
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 38
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 31
- num At Risk
- 258
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 258
- term
- LEUKOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 60
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 49
- num At Risk
- 258
- term
- NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 59
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 48
- num At Risk
- 258
- term
- THROMBOCYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 40
- num At Risk
- 258
- term
- EYELID OEDEMA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA (18.1)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 20
- num At Risk
- 258
- term
- PERIORBITAL OEDEMA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 36
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 258
- term
- ABDOMINAL PAIN
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 22
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 258
- term
- ABDOMINAL PAIN UPPER
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 258
- term
- CONSTIPATION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 99
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 89
- num At Risk
- 258
- term
- DIARRHOEA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 22
- num At Risk
- 258
- term
- DYSPEPSIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 23
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 258
- term
- GASTRITIS
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 258
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 258
- term
- BICYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 258
- term
- BONE MARROW FAILURE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 258
- term
- FEBRILE NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 258
- term
- NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 258
- term
- PANCYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 258
- term
- THROMBOCYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (18.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 258
- term
- LEUKOCYTOSIS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (18.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 258
- term
- THROMBOCYTOSIS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 258
- term
- ACUTE MYOCARDIAL INFARCTION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 258
- term
- ANGINA UNSTABLE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 12.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 258
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 258
- term
- CARDIAC ARREST
- time Frame
- Randomization to end of study (December 2015)
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Preserved source evidence · Not medical advice