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NCT00807768 · ADVERSE EVENTS

Adverse events

Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer · Source last updated 2019-03-20

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
AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment. Median treatment duration is approximately 8 weeks.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Pelvic Radiation Therapy)

Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments. 3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies

9 / 283245 / 283Not reported / Not reported
Arm II (Brachytherapy, Paclitaxel, Carboplatin)

Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies

32 / 290284 / 290Not reported / Not reported

Group identifiers: EG000: Arm I (Pelvic Radiation Therapy) · EG001: Arm II (Brachytherapy, Paclitaxel, Carboplatin)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      290
    term
    Neutrophils
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Platelets
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Leukocytes
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
    term
    Cardipulmonary Arrest
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Death No Ctcae Term - Death Nos
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Pruritus
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Urticaria
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Proctitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      290
    term
    Diarrhea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      290
    term
    Febrile Neutropenia

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      290
    term
    Allergic Reaction/Hypersensitivity
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      290
    term
    Rhinitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      290
    term
    Hearing (Without Monitoring Program)
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      290
    term
    Tinnitus
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      227
      num At Risk
      290
    term
    Neutrophils
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      135
      num At Risk
      290
    term
    Platelets
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      290
    term
    Blood/Bone Marrow - Other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      107
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      234
      num At Risk
      290
    term
    Leukocytes
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      290
    term
    Lymphopenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      206
      num At Risk
      290
    term
    Hemoglobin
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    S/N Arrhythmia: Atrial Fibrillation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      290
    term
    Palpitations
Complete source fields
event Groups
  1. description
    Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments. 3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    id
    EG000
    other Num Affected
    245
    other Num At Risk
    283
    serious Num Affected
    9
    serious Num At Risk
    283
    title
    Arm I (Pelvic Radiation Therapy)
  2. description
    Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    id
    EG001
    other Num Affected
    284
    other Num At Risk
    290
    serious Num Affected
    32
    serious Num At Risk
    290
    title
    Arm II (Brachytherapy, Paclitaxel, Carboplatin)
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      290
    term
    Allergic Reaction/Hypersensitivity
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      290
    term
    Rhinitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      290
    term
    Hearing (Without Monitoring Program)
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      290
    term
    Tinnitus
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      227
      num At Risk
      290
    term
    Neutrophils
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      135
      num At Risk
      290
    term
    Platelets
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      290
    term
    Blood/Bone Marrow - Other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      107
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      234
      num At Risk
      290
    term
    Leukocytes
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      290
    term
    Lymphopenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      206
      num At Risk
      290
    term
    Hemoglobin
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    S/N Arrhythmia: Atrial Fibrillation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      290
    term
    Palpitations
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      290
    term
    Neutrophils
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Platelets
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Leukocytes
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
    term
    Cardipulmonary Arrest
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Death No Ctcae Term - Death Nos
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Pruritus
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Urticaria
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Proctitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      290
    term
    Diarrhea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      290
    term
    Febrile Neutropenia
time Frame
AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment. Median treatment duration is approximately 8 weeks.

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