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NCT01175980 · OUTCOME

Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0

Vorinostat in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma · Source last updated 2020-08-03

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 180 days after the last dose of vorinostat maximum treatment duration= 24 months

What was measured

Toxicity will be tabulated via frequency distributions, and also dichotomized to report the proportion (and percentage) of patients experiencing a specified level (e.g., grade 3-4) of toxicity.

Groups in this outcome

Treatment (Vorinostat)

Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO

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

Analysis denominator · Participants

GroupSource count
Treatment (Vorinostat)30

Reported measurements

Appendicitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
Atelectasis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
Bronchial obstruction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
Bronchopulmonary hemorrhage
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
Cataract
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)3Not reportedNot reportedNot reportedNot reported
Headache
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)2Not reportedNot reportedNot reportedNot reported
Hypertension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)3Not reportedNot reportedNot reportedNot reported
Hypophosphatemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
Hypoxia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
Lung infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)7Not reportedNot reportedNot reportedNot reported
Lymphocyte count increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
Menorrhagia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
Mucositis oral
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
Non cardiac chest pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
Oral pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)2Not reportedNot reportedNot reportedNot reported
Platelet count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
PNEUMONIA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
Thromboembolic event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)2Not reportedNot reportedNot reportedNot reported
Wound complication
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Vorinostat)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Appendicitis
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Atelectasis
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Bronchial obstruction
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Bronchopulmonary hemorrhage
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Cataract
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Diarrhea
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Fatigue
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Headache
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Hypertension
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hypophosphatemia
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hypoxia
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Lung infection
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Toxicity will be tabulated via frequency distributions, and also dichotomized to report the proportion (and percentage) of patients experiencing a specified level (e.g., grade 3-4) of toxicity.
groups
  1. description
    Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
    id
    OG000
    title
    Treatment (Vorinostat)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months
title
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice