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NCT01196390 · ADVERSE EVENTS

Adverse events

Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer · Source last updated 2026-06-02

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
Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Chemoradiation and Trastuzumab

Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab

51 / 9595 / 9553 / 95
Chemoradiation

Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery

34 / 9696 / 9655 / 96

Group identifiers: EG000: Chemoradiation and Trastuzumab · EG001: Chemoradiation

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 (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      96
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
    term
    Acute coronary syndrome
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
    term
    Atrial fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
    term
    Atrial flutter
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
    term
    Cardiac arrest
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
    term
    Chest pain - cardiac
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
    term
    Pericardial effusion
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
    term
    Sinus tachycardia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
    term
    Supraventricular tachycardia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
    term
    Abdominal pain

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 (4.0)
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      96
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      96
    term
    Atrial fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      96
    term
    Cardiac disorders - Other, specify
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      96
    term
    Sinus tachycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      96
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      96
    term
    Bloating
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      96
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      96
    term
    Diarrhea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      96
    term
    Dry mouth
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      96
    term
    Dyspepsia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      96
    term
    Dysphagia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      96
    term
    Esophageal pain
Complete source fields
event Groups
  1. deaths Num Affected
    53
    deaths Num At Risk
    95
    description
    Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
    id
    EG000
    other Num Affected
    95
    other Num At Risk
    95
    serious Num Affected
    51
    serious Num At Risk
    95
    title
    Chemoradiation and Trastuzumab
  2. deaths Num Affected
    55
    deaths Num At Risk
    96
    description
    Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
    id
    EG001
    other Num Affected
    96
    other Num At Risk
    96
    serious Num Affected
    34
    serious Num At Risk
    96
    title
    Chemoradiation
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      96
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      96
    term
    Atrial fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      96
    term
    Cardiac disorders - Other, specify
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      96
    term
    Sinus tachycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      96
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      96
    term
    Bloating
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      96
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      96
    term
    Diarrhea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      96
    term
    Dry mouth
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      96
    term
    Dyspepsia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      96
    term
    Dysphagia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      96
    term
    Esophageal pain
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      96
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
    term
    Acute coronary syndrome
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
    term
    Atrial fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
    term
    Atrial flutter
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
    term
    Cardiac arrest
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
    term
    Chest pain - cardiac
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
    term
    Pericardial effusion
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
    term
    Sinus tachycardia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
    term
    Supraventricular tachycardia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
    term
    Abdominal pain
time Frame
Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.

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