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NCT00003830 · ADVERSE EVENTS

Adverse events

Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer · Source last updated 2017-12-13

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%

Participants at Risk includes any patient who submitted an AE form.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Conventional Axillary Dissection

Conventional axillary dissection

9 / 27880 / 27880 / 2788
Sentinel Node Resection Followed by Node Examination

Sentinel node resection followed by node examination

8 / 28000 / 28001 / 2800

Group identifiers: EG000: Conventional Axillary Dissection · EG001: Sentinel Node Resection Followed by Node Examination

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
    Immune system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      2788
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      2800
    term
    Anaphylaxis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2788
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2800
    term
    Infections and infestations - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2788
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2800
    term
    Nervous system disorders - Other, specify
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2788
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2800
    term
    Respiratory, thoracic and mediastinal disorders - Other, specify
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2788
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2800
    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.

    Complete source fields
    description
    Participants at Risk includes any patient who submitted an AE form.
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      2788
      description
      Conventional axillary dissection
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      2788
      serious Num Affected
      9
      serious Num At Risk
      2788
      title
      Conventional Axillary Dissection
    2. deaths Num Affected
      1
      deaths Num At Risk
      2800
      description
      Sentinel node resection followed by node examination
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      2800
      serious Num Affected
      8
      serious Num At Risk
      2800
      title
      Sentinel Node Resection Followed by Node Examination
    frequency Threshold
    5
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTCAE v4.0
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        2788
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        2800
      term
      Anaphylaxis
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE v4.0
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        2788
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        2800
      term
      Infections and infestations - Other, specify
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE v4.0
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        2788
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        2800
      term
      Nervous system disorders - Other, specify
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE v4.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2788
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        2800
      term
      Respiratory, thoracic and mediastinal disorders - Other, specify
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      source Vocabulary
      CTCAE v4.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2788
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        2800
      term
      Thromboembolic event

    Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

    Preserved source evidence · Not medical advice