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NCT02959463 · ADVERSE EVENTS

Adverse events

Pembrolizumab After Radiation Therapy in Treating Patients With Pleural Malignant Mesothelioma · Source last updated 2026-05-27

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
Baseline to 4-months after radiation therapy up to 5 years
Other-event reporting threshold
0%

Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1

Patient with lung intact to receive hemithoracic radiation therapy for definitive intent

6 / 1212 / 1211 / 12
Cohort 2

Patients with lung intact to receive non-hemithoracic radiation therapy(palliative radiation therapy)

3 / 1212 / 1212 / 12

Group identifiers: EG000: Cohort 1 · EG001: Cohort 2

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
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Death NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Dysphagia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Esophagitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Gastritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Lung infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Infections and infestations - Other
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Creatinine increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Hyperkalemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Anorexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Acute Kidney injury

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      12
      num Events
      12
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      12
      num Events
      8
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      12
      num Events
      8
    term
    Blood and lymphatic system disorders-Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Edema Limbs
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Atrial Flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Heart failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Ear Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Tinnitus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Endocrine disorders-Other,
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Hyperthyroidism
Complete source fields
description
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    12
    description
    Patient with lung intact to receive hemithoracic radiation therapy for definitive intent
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    6
    serious Num At Risk
    12
    title
    Cohort 1
  2. deaths Num Affected
    12
    deaths Num At Risk
    12
    description
    Patients with lung intact to receive non-hemithoracic radiation therapy(palliative radiation therapy)
    id
    EG001
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    3
    serious Num At Risk
    12
    title
    Cohort 2
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      12
      num Events
      12
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      12
      num Events
      8
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      12
      num Events
      8
    term
    Blood and lymphatic system disorders-Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Edema Limbs
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Atrial Flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Heart failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Ear Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Tinnitus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Endocrine disorders-Other,
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Hyperthyroidism
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Death NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Dysphagia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Esophagitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Gastritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Lung infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Infections and infestations - Other
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Creatinine increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Hyperkalemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Anorexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Acute Kidney injury
time Frame
Baseline to 4-months after radiation therapy up to 5 years

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