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NCT00750269 · ADVERSE EVENTS

Adverse events

Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer · Source last updated 2022-06-09

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%

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
Level 5: 10.0 Gy/FX

SBRT 50.0 Gy SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy

1 / 87 / 8Not reported / Not reported
Level 6: 10.5 Gy/FX

SBRT 52.5 Gy SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy

0 / 77 / 7Not reported / Not reported
Level 7: 11.0 Gy/FX

SBRT 55.0 Gy SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy

2 / 1413 / 14Not reported / Not reported
Level 8: 11.5 Gy/FX

SBRT 57.5 Gy SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

9 / 3834 / 38Not reported / Not reported
Level 9: 12.0 Gy/FX

SBRT 60.0 Gy SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy

7 / 3327 / 33Not reported / Not reported

Group identifiers: EG000: Level 5: 10.0 Gy/FX · EG001: Level 6: 10.5 Gy/FX · EG002: Level 7: 11.0 Gy/FX · EG003: Level 8: 11.5 Gy/FX · EG004: Level 9: 12.0 Gy/FX

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
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Heart failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Sinus bradycardia
  3. 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
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Dysphagia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Esophageal perforation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Esophagitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Gastritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Death NOS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Lung infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Intracranial hemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Atelectasis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Bronchial obstruction

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
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Chest pain - cardiac
  2. 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
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Conduction disorder
  3. 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
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    term
    Heart failure
  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
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Mitral valve disease
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Pericarditis
  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
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Tricuspid valve disease
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Diarrhea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      33
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Esophageal fistula
Complete source fields
description
Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
event Groups
  1. description
    SBRT 50.0 Gy SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    1
    serious Num At Risk
    8
    title
    Level 5: 10.0 Gy/FX
  2. description
    SBRT 52.5 Gy SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    0
    serious Num At Risk
    7
    title
    Level 6: 10.5 Gy/FX
  3. description
    SBRT 55.0 Gy SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
    id
    EG002
    other Num Affected
    13
    other Num At Risk
    14
    serious Num Affected
    2
    serious Num At Risk
    14
    title
    Level 7: 11.0 Gy/FX
  4. description
    SBRT 57.5 Gy SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy
    id
    EG003
    other Num Affected
    34
    other Num At Risk
    38
    serious Num Affected
    9
    serious Num At Risk
    38
    title
    Level 8: 11.5 Gy/FX
  5. description
    SBRT 60.0 Gy SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy
    id
    EG004
    other Num Affected
    27
    other Num At Risk
    33
    serious Num Affected
    7
    serious Num At Risk
    33
    title
    Level 9: 12.0 Gy/FX
frequency Threshold
5
other Events
  1. 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
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Chest pain - cardiac
  2. 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
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Conduction disorder
  3. 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
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    term
    Heart failure
  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
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Mitral valve disease
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Pericarditis
  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
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Tricuspid valve disease
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Diarrhea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      33
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Esophageal fistula
serious Events
  1. 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
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Heart failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Sinus bradycardia
  3. 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
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Dysphagia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Esophageal perforation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Esophagitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Gastritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Death NOS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Lung infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    term
    Intracranial hemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Atelectasis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    term
    Bronchial obstruction

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Preserved source evidence · Not medical advice