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NCT01085630 · OUTCOME

Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)

Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy · Source last updated 2021-08-18

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
Baseline up to 3 years

What was measured

The number of patients reporting grade 3 or higher adverse events considered at least possibly related to study treatment as graded by the NCI's Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.

Groups in this outcome

Arm B (Pemetrexed)

Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.

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

Analysis denominator · Participants

GroupSource count
Arm B (Pemetrexed)27

Reported measurements

Grade 3 Adverse Event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm B (Pemetrexed)9Not reportedNot reportedNot reportedNot reported
Grade 4 Adverse Event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm B (Pemetrexed)2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Grade 3 Adverse Event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Grade 4 Adverse Event
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    units
    Participants
description
The number of patients reporting grade 3 or higher adverse events considered at least possibly related to study treatment as graded by the NCI's Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.
groups
  1. description
    Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
    id
    OG000
    title
    Arm B (Pemetrexed)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Baseline up to 3 years
title
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice