Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02721732 · ADVERSE EVENTS

Adverse events

Pembrolizumab in Treating Patients With Rare Tumors That Cannot Be Removed by Surgery or Are Metastatic · Source last updated 2026-07-17

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
First day of administration of study medication through 30 days following last dose.
Other-event reporting threshold
0%

All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Participants With Advanced Rare Cancer

"MK-3475: 200 mg IV on Day 1 of every 21-day cycle Of the 157 participants enrolled, one participant in ACC cohort was excluded due to change in the diagnosis."

72 / 15684 / 156114 / 156

Group identifiers: EG000: Participants With Advanced Rare Cancer

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      156
      num Events
      8
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      156
      num Events
      6
    term
    Dyspnea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      156
      num Events
      5
    term
    Fever
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      156
      num Events
      5
    term
    Lung infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      156
      num Events
      5
    term
    Pleural effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      156
      num Events
      4
    term
    Pneumonitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      156
      num Events
      3
    term
    Anemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      156
      num Events
      3
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      156
      num Events
      3
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      156
      num Events
      3
    term
    Acute kidney injury
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      156
      num Events
      2
    term
    Aspartate aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      156
      num Events
      2
    term
    Hematoma

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
    General disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      156
      num Events
      55
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      156
      num Events
      52
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      156
      num Events
      41
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      156
      num Events
      35
    term
    Creatinine increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      156
      num Events
      32
    term
    Aspartate aminotransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      156
      num Events
      31
    term
    Alanine aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      156
      num Events
      31
    term
    Rash maculo-papular
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      156
      num Events
      28
    term
    Alkaline phosphatase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      156
      num Events
      28
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      156
      num Events
      27
    term
    Hypothyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      156
      num Events
      26
    term
    Dyspnea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      156
      num Events
      25
    term
    Hyperglycemia
Complete source fields
description
All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
event Groups
  1. deaths Num Affected
    114
    deaths Num At Risk
    156
    description
    "MK-3475: 200 mg IV on Day 1 of every 21-day cycle Of the 157 participants enrolled, one participant in ACC cohort was excluded due to change in the diagnosis."
    id
    EG000
    other Num Affected
    84
    other Num At Risk
    156
    serious Num Affected
    72
    serious Num At Risk
    156
    title
    Participants With Advanced Rare Cancer
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      156
      num Events
      55
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      156
      num Events
      52
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      156
      num Events
      41
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      156
      num Events
      35
    term
    Creatinine increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      156
      num Events
      32
    term
    Aspartate aminotransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      156
      num Events
      31
    term
    Alanine aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      156
      num Events
      31
    term
    Rash maculo-papular
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      156
      num Events
      28
    term
    Alkaline phosphatase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      156
      num Events
      28
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      156
      num Events
      27
    term
    Hypothyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      156
      num Events
      26
    term
    Dyspnea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      156
      num Events
      25
    term
    Hyperglycemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      156
      num Events
      8
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      156
      num Events
      6
    term
    Dyspnea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      156
      num Events
      5
    term
    Fever
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      156
      num Events
      5
    term
    Lung infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      156
      num Events
      5
    term
    Pleural effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      156
      num Events
      4
    term
    Pneumonitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      156
      num Events
      3
    term
    Anemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      156
      num Events
      3
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      156
      num Events
      3
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      156
      num Events
      3
    term
    Acute kidney injury
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      156
      num Events
      2
    term
    Aspartate aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      156
      num Events
      2
    term
    Hematoma
time Frame
First day of administration of study medication through 30 days following last dose.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice