NCT00525057 · 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
- 4 weeks after surgery
- Other-event reporting threshold
- 5%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Interventional (Dalteparin, Metastatic) | 1 / 25 | 1 / 25 | 0 / 25 |
| Interventional (Dalteparin, Sarcoma) | 0 / 25 | 4 / 25 | 0 / 25 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 25
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- term
- Thromboembolic event
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Surgical and medical procedures
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 25
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 25
- term
- Seroma
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Surgical and medical procedures
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 25
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 25
- term
- Wound infection
Complete source fields
- event Groups
- deaths Num Affected
- 0
- deaths Num At Risk
- 25
- description
- Received dalteparin 5000 units daily postop, patients with metastatic disease.
- id
- EG000
- other Num Affected
- 1
- other Num At Risk
- 25
- serious Num Affected
- 1
- serious Num At Risk
- 25
- title
- Interventional (Dalteparin, Metastatic)
- deaths Num Affected
- 0
- deaths Num At Risk
- 25
- description
- Received dalteparin 5000 units daily postop, patients with primary sarcomas.
- id
- EG001
- other Num Affected
- 4
- other Num At Risk
- 25
- serious Num Affected
- 0
- serious Num At Risk
- 25
- title
- Interventional (Dalteparin, Sarcoma)
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Surgical and medical procedures
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 25
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 25
- term
- Seroma
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Surgical and medical procedures
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 25
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 25
- term
- Wound infection
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 25
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- term
- Thromboembolic event
- time Frame
- 4 weeks after surgery
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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