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NCT02186847 · ADVERSE EVENTS

Adverse events

Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer · Source last updated 2026-07-13

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
Adverse events were to be reported weekly during dose escalation on metformin arm, end of chemoradiation, end of post-radiation chemotherapy/metformin, 4-6 weeks follow-up, every 3 months for 2 years follow-up, every 6 months through 5 years follow-up, yearly until study termination completion.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Chemoradiation

60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin

31 / 7675 / 7631 / 76
Metformin + Chemoradiation

Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin

27 / 8279 / 8234 / 82

Group identifiers: EG000: Chemoradiation · EG001: Metformin + 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
      3
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    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
      4
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    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
      2
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    term
    Atrial fibrillation
  4. 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
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    term
    Atrial flutter
  5. 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
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    term
    Cardiac disorders - Other
  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
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    term
    Heart failure
  7. 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
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    term
    Sinus tachycardia
  8. 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
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    term
    Diarrhea
  9. 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
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    term
    Dysphagia
  10. 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
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    term
    Esophageal pain
  11. 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
      76
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      82
    term
    Esophagitis
  12. 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
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    term
    Mucositis oral

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
      50
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      82
    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
      76
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      82
    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
      76
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      82
    term
    Sinus tachycardia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    term
    Hearing impaired
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      82
    term
    Blurred vision
  6. 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
      76
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      82
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      82
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      82
    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
      76
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      82
    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
      11
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      82
    term
    Dyspepsia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      82
    term
    Dysphagia
  12. 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
      76
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      82
    term
    Esophageal pain
Complete source fields
event Groups
  1. deaths Num Affected
    31
    deaths Num At Risk
    76
    description
    60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
    id
    EG000
    other Num Affected
    75
    other Num At Risk
    76
    serious Num Affected
    31
    serious Num At Risk
    76
    title
    Chemoradiation
  2. deaths Num Affected
    34
    deaths Num At Risk
    82
    description
    Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
    id
    EG001
    other Num Affected
    79
    other Num At Risk
    82
    serious Num Affected
    27
    serious Num At Risk
    82
    title
    Metformin + 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
      50
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      82
    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
      76
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      82
    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
      76
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      82
    term
    Sinus tachycardia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    term
    Hearing impaired
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      82
    term
    Blurred vision
  6. 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
      76
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      82
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      82
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      82
    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
      76
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      82
    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
      11
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      82
    term
    Dyspepsia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      82
    term
    Dysphagia
  12. 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
      76
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      82
    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
      3
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    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
      4
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    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
      2
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    term
    Atrial fibrillation
  4. 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
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    term
    Atrial flutter
  5. 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
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    term
    Cardiac disorders - Other
  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
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    term
    Heart failure
  7. 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
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    term
    Sinus tachycardia
  8. 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
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    term
    Diarrhea
  9. 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
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    term
    Dysphagia
  10. 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
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    term
    Esophageal pain
  11. 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
      76
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      82
    term
    Esophagitis
  12. 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
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    term
    Mucositis oral
time Frame
Adverse events were to be reported weekly during dose escalation on metformin arm, end of chemoradiation, end of post-radiation chemotherapy/metformin, 4-6 weeks follow-up, every 3 months for 2 years follow-up, every 6 months through 5 years follow-up, yearly until study termination completion.

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