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NCT02538510 · ADVERSE EVENTS

Adverse events

Pembrolizumab and Vorinostat in Treating Patients With Recurrent Squamous Cell Head and Neck Cancer or Salivary Gland Cancer That Is Metastatic and/or Cannot Be Removed by Surgery · Source last updated 2024-11-26

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
All-Cause Mortality was monitored for up to 7 years and 6 months; serious and/or other adverse events were assessed up to 3 years and 6 months.
Other-event reporting threshold
0%

Adverse events are collected from the first dose of Mk-3475 or Vorinostat, and are collected through 30 days post the last dose of therapy.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Head and Neck Squamous Cell Carcinoma

MK-3475 combined with vorinostat in HNSCC patients

1 / 2511 / 2522 / 25
Salivary Gland Carcinoma

MK-3475 combined with vorinostat in SGC patients

1 / 2519 / 2523 / 25

Group identifiers: EG000: Head and Neck Squamous Cell Carcinoma · EG001: Salivary Gland Carcinoma

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
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Adrenal Insufficiency
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Pneumonitis

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
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    alanine amintotransferase (ALT) increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    asparate aminotransferase (AST) increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    cough
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      25
      num Events
      6
    term
    creatinine increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      25
      num Events
      6
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Fever with Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Hyponatremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Malaise
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
      num Events
      4
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Neuritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Adrenal insufficiency
Complete source fields
description
Adverse events are collected from the first dose of Mk-3475 or Vorinostat, and are collected through 30 days post the last dose of therapy.
event Groups
  1. deaths Num Affected
    22
    deaths Num At Risk
    25
    description
    MK-3475 combined with vorinostat in HNSCC patients
    id
    EG000
    other Num Affected
    11
    other Num At Risk
    25
    serious Num Affected
    1
    serious Num At Risk
    25
    title
    Head and Neck Squamous Cell Carcinoma
  2. deaths Num Affected
    23
    deaths Num At Risk
    25
    description
    MK-3475 combined with vorinostat in SGC patients
    id
    EG001
    other Num Affected
    19
    other Num At Risk
    25
    serious Num Affected
    1
    serious Num At Risk
    25
    title
    Salivary Gland Carcinoma
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    alanine amintotransferase (ALT) increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    asparate aminotransferase (AST) increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    cough
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      25
      num Events
      6
    term
    creatinine increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      25
      num Events
      6
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Fever with Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Hyponatremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Malaise
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
      num Events
      4
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Neuritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Adrenal insufficiency
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Adrenal Insufficiency
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Pneumonitis
time Frame
All-Cause Mortality was monitored for up to 7 years and 6 months; serious and/or other adverse events were assessed up to 3 years and 6 months.

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