NCT01484626 · 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
- Adverse event data were collected from November 2011 through June 2014 (32 months)
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Bendamustine | 0 / 3 | 3 / 3 | 0 / 3 |
Serious adverse events
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Upper respiratory infection
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Anemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 3
- num Events
- 2
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 3
- num Events
- 2
- term
- Shortness of Breath on Exertion
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Decreased appetite
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Nausea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Neuropathy
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Anxiety
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Arthritis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Hypercalcemia
Complete source fields
- event Groups
- deaths Num Affected
- 0
- deaths Num At Risk
- 3
- description
- Bendamustine is combined with standard chemotherapy
- id
- EG000
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 0
- serious Num At Risk
- 3
- title
- Bendamustine
- frequency Threshold
- 0
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Upper respiratory infection
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Anemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 3
- num Events
- 2
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 3
- num Events
- 2
- term
- Shortness of Breath on Exertion
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Decreased appetite
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Nausea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Neuropathy
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Anxiety
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Arthritis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Hypercalcemia
- time Frame
- Adverse event data were collected from November 2011 through June 2014 (32 months)
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