NCT00940225 · 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 |
|---|---|---|---|
| RDT All Cohorts | 223 / 526 | 524 / 526 | 54 / 526 |
| NRE Cohort - CRPC 100mg (Castration-Resistant Prostate Cancer) | 53 / 93 | 93 / 93 | 53 / 93 |
| NRE Cohort - CRPC 39.4mg (Castration-Resistant Prostate Cancer) | 30 / 51 | 50 / 51 | 13 / 51 |
| NRE Cohort - Ovarian 100mg | 34 / 60 | 59 / 60 | 33 / 60 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Acute Myocardial Infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Angina Pectoris
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Atrial Fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Atrioventricular Block
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Cardiac Arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Cardiac Failure Congestive
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Cardiac Tamponade
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Coronary Artery Stenosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Palpitations
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Pericardial Effusion
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 63
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 29
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 10
- num At Risk
- 60
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 27
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 5
- num At Risk
- 60
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 35
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 60
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 58
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 60
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- stats
- group Id
- EG000
- num Affected
- 66
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 15
- num At Risk
- 60
- term
- Hypothyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 31
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 10
- num At Risk
- 60
- term
- Abdominal Distension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 52
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 60
- term
- Abdominal Pain Upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 168
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 32
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 16
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 21
- num At Risk
- 60
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 314
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 66
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 23
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 46
- num At Risk
- 60
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 87
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 12
- num At Risk
- 60
- term
- Dry Mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 63
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 15
- num At Risk
- 60
- term
- Dyspepsia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 38
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 8
- num At Risk
- 60
- term
- Dysphagia
Complete source fields
- event Groups
- deaths Num Affected
- 54
- deaths Num At Risk
- 526
- description
- Includes all tumor types from the 203 RDT cohort: castration-resistant prostate cancer (CRPC), melanoma, non-small cell lung cancer (NSCLC), pancreatic cancer, gastric/gastroesophageal junction (GEJ) cancer, hepatocellular carcinoma (HCC), small cell lung cancer (SCLC), ovarian cancer, and metastatic breast cancer
- id
- EG000
- other Num Affected
- 524
- other Num At Risk
- 526
- serious Num Affected
- 223
- serious Num At Risk
- 526
- title
- RDT All Cohorts
- deaths Num Affected
- 53
- deaths Num At Risk
- 93
- description
- Subjects received a single oral daily dose of cabozantinib at 100 mg.
- id
- EG001
- other Num Affected
- 93
- other Num At Risk
- 93
- serious Num Affected
- 53
- serious Num At Risk
- 93
- title
- NRE Cohort - CRPC 100mg (Castration-Resistant Prostate Cancer)
- deaths Num Affected
- 13
- deaths Num At Risk
- 51
- description
- Subjects received a single oral daily dose of cabozantinib at 39.4 mg.
- id
- EG002
- other Num Affected
- 50
- other Num At Risk
- 51
- serious Num Affected
- 30
- serious Num At Risk
- 51
- title
- NRE Cohort - CRPC 39.4mg (Castration-Resistant Prostate Cancer)
- deaths Num Affected
- 33
- deaths Num At Risk
- 60
- description
- Subjects received a single oral daily dose of cabozantinib at 100 mg.
- id
- EG003
- other Num Affected
- 59
- other Num At Risk
- 60
- serious Num Affected
- 34
- serious Num At Risk
- 60
- title
- NRE Cohort - Ovarian 100mg
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 63
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 29
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 10
- num At Risk
- 60
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 27
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 5
- num At Risk
- 60
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 35
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 60
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 58
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 60
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- stats
- group Id
- EG000
- num Affected
- 66
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 15
- num At Risk
- 60
- term
- Hypothyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 31
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 10
- num At Risk
- 60
- term
- Abdominal Distension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 52
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 60
- term
- Abdominal Pain Upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 168
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 32
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 16
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 21
- num At Risk
- 60
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 314
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 66
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 23
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 46
- num At Risk
- 60
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 87
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 12
- num At Risk
- 60
- term
- Dry Mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 63
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 15
- num At Risk
- 60
- term
- Dyspepsia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 38
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 8
- num At Risk
- 60
- term
- Dysphagia
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Acute Myocardial Infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Angina Pectoris
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Atrial Fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Atrioventricular Block
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Cardiac Arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Cardiac Failure Congestive
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Cardiac Tamponade
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Coronary Artery Stenosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Palpitations
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 526
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 93
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 51
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 60
- term
- Pericardial Effusion
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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