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NCT00074152 · ADVERSE EVENTS

Adverse events

Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer · Source last updated 2017-06-16

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
From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I

Observation (+/- Radiation). Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery

0 / 770 / 77Not reported / Not reported
Arm II

Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.

12 / 850 / 85Not reported / Not reported

Group identifiers: EG000: Arm I · EG001: Arm II

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
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      77
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      85
      num Events
      3
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      77
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
      num Events
      1
    term
    Left ventricular dysfunction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      77
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
      num Events
      1
    term
    Pulmonary/upper respiratory infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      77
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
      num Events
      1
    term
    Gastrointestinal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      77
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
      num Events
      1
    term
    Diverticulitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Neutropenia with symptoms of generalized musculoskeletal pain and fatigue
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      77
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
      num Events
      1
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      77
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
      num Events
      1
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      77
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      85
      num Events
      2
    term
    Cardiac ischemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      77
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
      num Events
      1
    term
    Motor neuropathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      77
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
      num Events
      1
    term
    Endometrial mucosa thinkening

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
    event Groups
    1. description
      Observation (+/- Radiation). Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      77
      serious Num Affected
      0
      serious Num At Risk
      77
      title
      Arm I
    2. description
      Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      85
      serious Num Affected
      12
      serious Num At Risk
      85
      title
      Arm II
    frequency Threshold
    0
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        77
        num Events
        0
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        85
        num Events
        3
      term
      Febrile neutropenia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        77
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        85
        num Events
        1
      term
      Left ventricular dysfunction
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        77
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        85
        num Events
        1
      term
      Pulmonary/upper respiratory infection
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        77
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        85
        num Events
        1
      term
      Gastrointestinal pain
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        77
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        85
        num Events
        1
      term
      Diverticulitis
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Neutropenia with symptoms of generalized musculoskeletal pain and fatigue
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        77
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        85
        num Events
        1
      term
      Neutropenia
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        77
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        85
        num Events
        1
      term
      Colitis
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        77
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        85
        num Events
        2
      term
      Cardiac ischemia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        77
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        85
        num Events
        1
      term
      Motor neuropathy
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        77
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        85
        num Events
        1
      term
      Endometrial mucosa thinkening
    time Frame
    From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)

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

    Preserved source evidence · Not medical advice