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NCT02538510 · OUTCOME

Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 30 days after the completion of study treatment

What was measured

Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 4.0

Analysis population: Only G3 toxicities and toxicities requiring dose hold/reduction recorded.

Groups in this outcome

Head and Neck Squamous Cell Carcinoma

AEs experienced with MK-3475 combined with vorinostat in HNSCC patients

Salivary Gland Carcinoma

AEs experienced with MK-3475 combined with vorinostat in salivary gland carcinoma patients

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Head and Neck Squamous Cell Carcinoma25
Salivary Gland Carcinoma25

Reported measurements

Adrenal insufficiency
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma1Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma1Not reportedNot reportedNot reportedNot reported
ALT increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma0Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma1Not reportedNot reportedNot reportedNot reported
Anorexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma0Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma1Not reportedNot reportedNot reportedNot reported
Arthiritis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma0Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma1Not reportedNot reportedNot reportedNot reported
AST increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma0Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma1Not reportedNot reportedNot reportedNot reported
Cough
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma1Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma0Not reportedNot reportedNot reportedNot reported
Increased Creatinine
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma2Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma5Not reportedNot reportedNot reportedNot reported
Dermatitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma1Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma0Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma0Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma1Not reportedNot reportedNot reportedNot reported
Fever with leukocytosis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma0Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma1Not reportedNot reportedNot reportedNot reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma2Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma4Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma2Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma0Not reportedNot reportedNot reportedNot reported
Hypothyroidism
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma1Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma0Not reportedNot reportedNot reportedNot reported
Colitis and Ileitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma1Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma0Not reportedNot reportedNot reportedNot reported
Malaise
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma1Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma0Not reportedNot reportedNot reportedNot reported
Nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma1Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma3Not reportedNot reportedNot reportedNot reported
Nephritis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma0Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma1Not reportedNot reportedNot reportedNot reported
Pneumonitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma1Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma0Not reportedNot reportedNot reportedNot reported
Neuritis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma0Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma1Not reportedNot reportedNot reportedNot reported
Tracheitis/Epiglottitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma1Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma0Not reportedNot reportedNot reportedNot reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell Carcinoma1Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Adrenal insufficiency
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    ALT increase
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Anorexia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Arthiritis
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    AST increase
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Cough
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        5
    title
    Increased Creatinine
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Dermatitis
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Diarrhea
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Fever with leukocytosis
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
    title
    Fatigue
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Hyponatremia
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      25
    units
    Participants
description
Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 4.0
groups
  1. description
    AEs experienced with MK-3475 combined with vorinostat in HNSCC patients
    id
    OG000
    title
    Head and Neck Squamous Cell Carcinoma
  2. description
    AEs experienced with MK-3475 combined with vorinostat in salivary gland carcinoma patients
    id
    OG001
    title
    Salivary Gland Carcinoma
param Type
COUNT_OF_PARTICIPANTS
population Description
Only G3 toxicities and toxicities requiring dose hold/reduction recorded.
reporting Status
POSTED
time Frame
Up to 30 days after the completion of study treatment
title
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice