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NCT00316225 · OUTCOME

Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities

Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen · Source last updated 2010-07-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
baseline, up to 18 weeks

What was measured

Number of participants with laboratory and non-laboratory toxicities possibly related to study drug, which were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. Grades range from 0 (none) to 5 (death). Grade 3 is severe and Grade 4 is life-threatening. NOS = Not otherwise specified.

Analysis population: Patients who received at least one dose of study drug.

Groups in this outcome

Pemetrexed

Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles

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

Analysis denominator · Participants

GroupSource count
Pemetrexed31

Reported measurements

Leukocytopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed1Not reportedNot reportedNot reportedNot reported
Neutropenia/Granulocytopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed1Not reportedNot reportedNot reportedNot reported
Platelets
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed1Not reportedNot reportedNot reportedNot reported
Ascites (Non-Malignant)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed1Not reportedNot reportedNot reportedNot reported
Febrile Neutropenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed1Not reportedNot reportedNot reportedNot reported
Pain Pulmonary/Upper Respiratory-Chest/Thorax NOS
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed1Not reportedNot reportedNot reportedNot reported
Pleural Effusion (Non-Malignant)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Leukocytopenia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Neutropenia/Granulocytopenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Platelets
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Ascites (Non-Malignant)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Febrile Neutropenia
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Pain Pulmonary/Upper Respiratory-Chest/Thorax NOS
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Pleural Effusion (Non-Malignant)
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
Number of participants with laboratory and non-laboratory toxicities possibly related to study drug, which were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. Grades range from 0 (none) to 5 (death). Grade 3 is severe and Grade 4 is life-threatening. NOS = Not otherwise specified.
groups
  1. description
    Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
    id
    OG000
    title
    Pemetrexed
param Type
NUMBER
population Description
Patients who received at least one dose of study drug.
reporting Status
POSTED
time Frame
baseline, up to 18 weeks
title
Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice