Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03142334 · ADVERSE EVENTS

Adverse events

Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564) · Source last updated 2026-03-10

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 approximately 43 months (Database cutoff date 14 Dec 2020).
Other-event reporting threshold
5%

All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.

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

Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).

100 / 488436 / 48818 / 496
Placebo

Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).

56 / 496393 / 49633 / 498

Group identifiers: EG000: Pembrolizumab · EG001: Placebo

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 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      488
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      496
      num Events
      0
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      488
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      496
      num Events
      1
    term
    Acute myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      488
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      496
      num Events
      2
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      488
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      496
      num Events
      0
    term
    Bundle branch block left
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      488
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      496
      num Events
      1
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      488
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      496
      num Events
      1
    term
    Coronary artery stenosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      488
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      496
      num Events
      0
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      488
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      496
      num Events
      0
    term
    Myocarditis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      488
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      496
      num Events
      0
    term
    Pleuropericarditis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      488
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      496
      num Events
      0
    term
    Sinus node dysfunction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      488
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      496
      num Events
      1
    term
    Vertigo
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      488
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      496
      num Events
      0
    term
    Adrenal insufficiency

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
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      488
      num Events
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      496
      num Events
      1
    term
    Hyperthyroidism
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      103
      num At Risk
      488
      num Events
      111
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      496
      num Events
      20
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      488
      num Events
      54
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      496
      num Events
      50
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      488
      num Events
      39
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      496
      num Events
      42
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      488
      num Events
      195
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      496
      num Events
      171
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      488
      num Events
      37
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      496
      num Events
      5
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      488
      num Events
      105
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      496
      num Events
      61
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      488
      num Events
      44
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      496
      num Events
      31
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      488
      num Events
      85
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      496
      num Events
      50
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      145
      num At Risk
      488
      num Events
      180
    2. group Id
      EG001
      num Affected
      120
      num At Risk
      496
      num Events
      156
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      488
      num Events
      26
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      496
      num Events
      24
    term
    Influenza like illness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      488
      num Events
      26
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      496
      num Events
      30
    term
    Oedema peripheral
Complete source fields
description
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
event Groups
  1. deaths Num Affected
    18
    deaths Num At Risk
    496
    description
    Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
    id
    EG000
    other Num Affected
    436
    other Num At Risk
    488
    serious Num Affected
    100
    serious Num At Risk
    488
    title
    Pembrolizumab
  2. deaths Num Affected
    33
    deaths Num At Risk
    498
    description
    Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
    id
    EG001
    other Num Affected
    393
    other Num At Risk
    496
    serious Num Affected
    56
    serious Num At Risk
    496
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      488
      num Events
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      496
      num Events
      1
    term
    Hyperthyroidism
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      103
      num At Risk
      488
      num Events
      111
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      496
      num Events
      20
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      488
      num Events
      54
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      496
      num Events
      50
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      488
      num Events
      39
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      496
      num Events
      42
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      488
      num Events
      195
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      496
      num Events
      171
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      488
      num Events
      37
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      496
      num Events
      5
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      488
      num Events
      105
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      496
      num Events
      61
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      488
      num Events
      44
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      496
      num Events
      31
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      488
      num Events
      85
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      496
      num Events
      50
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      145
      num At Risk
      488
      num Events
      180
    2. group Id
      EG001
      num Affected
      120
      num At Risk
      496
      num Events
      156
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      488
      num Events
      26
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      496
      num Events
      24
    term
    Influenza like illness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      488
      num Events
      26
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      496
      num Events
      30
    term
    Oedema peripheral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      488
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      496
      num Events
      0
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      488
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      496
      num Events
      1
    term
    Acute myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      488
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      496
      num Events
      2
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      488
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      496
      num Events
      0
    term
    Bundle branch block left
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      488
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      496
      num Events
      1
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      488
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      496
      num Events
      1
    term
    Coronary artery stenosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      488
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      496
      num Events
      0
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      488
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      496
      num Events
      0
    term
    Myocarditis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      488
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      496
      num Events
      0
    term
    Pleuropericarditis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      488
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      496
      num Events
      0
    term
    Sinus node dysfunction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      488
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      496
      num Events
      1
    term
    Vertigo
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      488
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      496
      num Events
      0
    term
    Adrenal insufficiency
time Frame
Up to approximately 43 months (Database cutoff date 14 Dec 2020).

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice