NCT05024994 · 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
- 1 year
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| E7820 | 9 / 12 | 10 / 12 | 5 / 12 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Dysphagia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Dyspnea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Pruritus
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Urinary tract pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Reproductive system and breast disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Vaginal discharge
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Cardiac arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Respiratory failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Sepsis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 12
- term
- Death NOS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Intercranial hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Hematoma
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 12
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 12
- term
- Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 12
- term
- Non-cardiac chest pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 12
- term
- Epistaxis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 12
- term
- Fall
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 12
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Fever
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Hematoma
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Lung infection
Complete source fields
- event Groups
- deaths Num Affected
- 5
- deaths Num At Risk
- 12
- description
- Each patient will receive daily administration of E7820. The starting dose for every patient will be 100 mg daily but the dose can subsequently be reduced if excessive toxicity is encountered. E7820: 100mg of E7820 QD
- id
- EG000
- other Num Affected
- 10
- other Num At Risk
- 12
- serious Num Affected
- 9
- serious Num At Risk
- 12
- title
- E7820
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 12
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 12
- term
- Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 12
- term
- Non-cardiac chest pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 12
- term
- Epistaxis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 12
- term
- Fall
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 12
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Fever
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Hematoma
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Lung infection
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Dysphagia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Dyspnea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Pruritus
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Urinary tract pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Reproductive system and breast disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Vaginal discharge
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Cardiac arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Respiratory failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- term
- Sepsis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 12
- term
- Death NOS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Intercranial hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- term
- Hematoma
- time Frame
- 1 year
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