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NCT02949219 · ADVERSE EVENTS

Adverse events

Pembrolizumab in Treating Patients With Small Bowel Adenocarcinoma That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery · Source last updated 2024-08-22

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
Up to 2 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Pembrolizumab)

Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

21 / 4034 / 4028 / 40

Group identifiers: EG000: Treatment (Pembrolizumab)

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      2
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Gastrointestinal disorders - Oth spec
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      2
    term
    Pancreatitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      3
    term
    Small intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Cholecystitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Gallbladder obstruction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Hepatic failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Hepatobiliary disorders - Other, specify
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Lung infection

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
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      4
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      3
    term
    Endocrine disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      40
      num Events
      10
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      40
      num Events
      45
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      2
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      7
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      2
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      7
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      9
    term
    Localized edema
Complete source fields
event Groups
  1. deaths Num Affected
    28
    deaths Num At Risk
    40
    description
    Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    34
    other Num At Risk
    40
    serious Num Affected
    21
    serious Num At Risk
    40
    title
    Treatment (Pembrolizumab)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      4
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      3
    term
    Endocrine disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      40
      num Events
      10
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      40
      num Events
      45
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      2
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      7
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      2
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      7
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      9
    term
    Localized edema
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      2
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Gastrointestinal disorders - Oth spec
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      2
    term
    Pancreatitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      3
    term
    Small intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Cholecystitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Gallbladder obstruction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Hepatic failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Hepatobiliary disorders - Other, specify
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Lung infection
time Frame
Up to 2 years

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