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NCT00331760 · ADVERSE EVENTS

Adverse events

Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery · Source last updated 2019-02-26

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%

Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Endometrial Cancer: IMRT

Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)

2 / 4342 / 43Not reported / Not reported
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)

Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)

3 / 4039 / 40Not reported / Not reported

Group identifiers: EG000: Endometrial Cancer: IMRT · EG001: Cervical Cancer: IMRT + Chemotherapy (Cisplatin)

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Diarrhoea NOS
  2. 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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Nausea
  3. 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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Rectal hemorrhage
  4. 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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Vomiting NOS
  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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Fatigue
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Urinary tract infection NOS
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Lymphopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Neutrophil count
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Dehydration
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Hypocalcemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Hypokalemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Arthralgia

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      40
    term
    Hemoglobin
  2. 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
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Hearing impaired
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      40
    term
    Tinnitus
  4. 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
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Abdominal distention
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      40
    term
    Abdominal pain NOS
  6. 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
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Anal discomfort
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      40
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      40
    term
    Diarrhoea NOS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Dyspepsia
  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
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Dysphagia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Enteritis
  12. 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
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Flatulence
Complete source fields
description
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
event Groups
  1. description
    Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
    id
    EG000
    other Num Affected
    42
    other Num At Risk
    43
    serious Num Affected
    2
    serious Num At Risk
    43
    title
    Endometrial Cancer: IMRT
  2. description
    Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
    id
    EG001
    other Num Affected
    39
    other Num At Risk
    40
    serious Num Affected
    3
    serious Num At Risk
    40
    title
    Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
frequency Threshold
5
other 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
      11
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      40
    term
    Hemoglobin
  2. 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
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Hearing impaired
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      40
    term
    Tinnitus
  4. 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
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Abdominal distention
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      40
    term
    Abdominal pain NOS
  6. 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
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Anal discomfort
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      40
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      40
    term
    Diarrhoea NOS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Dyspepsia
  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
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Dysphagia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Enteritis
  12. 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
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Flatulence
serious Events
  1. 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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Diarrhoea NOS
  2. 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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Nausea
  3. 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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Rectal hemorrhage
  4. 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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Vomiting NOS
  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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Fatigue
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Urinary tract infection NOS
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Lymphopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Neutrophil count
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Dehydration
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Hypocalcemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Hypokalemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Arthralgia

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