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NCT01507428 · ADVERSE EVENTS

Adverse events

Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy for Stage III Non-small Cell Lung Cancer · Source last updated 2026-04-21

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 randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Standard Radiation Therapy

60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.

16 / 4342 / 4326 / 43
Adaptive Radiation Therapy

A maximum of 80.4 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. Radiation therapy dose is individualized for final 9 fractions based on imaging results from PET/CT scan between fractions 18 and 19.

26 / 8483 / 8451 / 84

Group identifiers: EG000: Standard Radiation Therapy · EG001: Adaptive Radiation Therapy

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
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      84
    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
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
    term
    Febrile neutropenia
  3. 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
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      84
    term
    Supraventricular tachycardia
  4. 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
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      84
    term
    Abdominal pain
  5. 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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
    term
    Diarrhea
  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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
    term
    Dysphagia
  7. 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
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      84
    term
    Esophageal pain
  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
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      84
    term
    Esophageal stenosis
  9. 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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
    term
    Esophageal ulcer
  10. 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
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      84
    term
    Esophagitis
  11. 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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
    term
    Gastrointestinal disorders - Other
  12. 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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
    term
    Ileus

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
      20
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      84
    term
    Anemia
  2. 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
      43
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      84
    term
    Sinus tachycardia
  3. 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
      43
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      84
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      84
    term
    Constipation
  5. 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
      43
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      84
    term
    Diarrhea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      84
    term
    Dyspepsia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      84
    term
    Dysphagia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      84
    term
    Esophageal pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      84
    term
    Esophagitis
  10. 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
      43
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      84
    term
    Gastroesophageal reflux disease
  11. 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
      43
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      84
    term
    Mucositis oral
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      84
    term
    Nausea
Complete source fields
event Groups
  1. deaths Num Affected
    26
    deaths Num At Risk
    43
    description
    60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
    id
    EG000
    other Num Affected
    42
    other Num At Risk
    43
    serious Num Affected
    16
    serious Num At Risk
    43
    title
    Standard Radiation Therapy
  2. deaths Num Affected
    51
    deaths Num At Risk
    84
    description
    A maximum of 80.4 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. Radiation therapy dose is individualized for final 9 fractions based on imaging results from PET/CT scan between fractions 18 and 19.
    id
    EG001
    other Num Affected
    83
    other Num At Risk
    84
    serious Num Affected
    26
    serious Num At Risk
    84
    title
    Adaptive Radiation Therapy
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
      20
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      84
    term
    Anemia
  2. 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
      43
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      84
    term
    Sinus tachycardia
  3. 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
      43
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      84
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      84
    term
    Constipation
  5. 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
      43
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      84
    term
    Diarrhea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      84
    term
    Dyspepsia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      84
    term
    Dysphagia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      84
    term
    Esophageal pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      84
    term
    Esophagitis
  10. 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
      43
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      84
    term
    Gastroesophageal reflux disease
  11. 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
      43
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      84
    term
    Mucositis oral
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      84
    term
    Nausea
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
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      84
    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
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
    term
    Febrile neutropenia
  3. 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
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      84
    term
    Supraventricular tachycardia
  4. 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
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      84
    term
    Abdominal pain
  5. 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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
    term
    Diarrhea
  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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
    term
    Dysphagia
  7. 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
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      84
    term
    Esophageal pain
  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
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      84
    term
    Esophageal stenosis
  9. 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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
    term
    Esophageal ulcer
  10. 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
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      84
    term
    Esophagitis
  11. 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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
    term
    Gastrointestinal disorders - Other
  12. 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
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      84
    term
    Ileus
time Frame
From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.

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