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NCT00316225 · OUTCOME

Discontinuations Due to Adverse Events

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

Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 11.0.

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

Atrial fibrillation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed1Not reportedNot reportedNot reportedNot reported
Febrile neutropenia (possibly related)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed1Not reportedNot reportedNot reportedNot reported
Pneumonia (resulted in death)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed1Not reportedNot reportedNot reportedNot reported
Respiratory failure (resulted in death)
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
    Atrial fibrillation
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Febrile neutropenia (possibly related)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Pneumonia (resulted in death)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Respiratory failure (resulted in death)
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 11.0.
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
Discontinuations Due to Adverse Events
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice