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NCT00525057 · ADVERSE EVENTS

Adverse events

Dalteparin in Preventing DVT in Participants With Cancer · Source last updated 2021-01-22

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Interventional (Dalteparin, Metastatic)

Received dalteparin 5000 units daily postop, patients with metastatic disease.

1 / 251 / 250 / 25
Interventional (Dalteparin, Sarcoma)

Received dalteparin 5000 units daily postop, patients with primary sarcomas.

0 / 254 / 250 / 25

Group identifiers: EG000: Interventional (Dalteparin, Metastatic) · EG001: Interventional (Dalteparin, Sarcoma)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    term
    Thromboembolic event

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      25
    term
    Seroma
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    term
    Wound infection
Complete source fields
event Groups
  1. 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)
  2. 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
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      25
    term
    Seroma
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    term
    Wound infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. 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