Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00369564 · OUTCOME

Number of Participants With Neurotoxicity Observed

Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer · Source last updated 2021-08-11

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
10 weeks

What was measured

Number of participants with neurotoxicity observed treated with l-glutamic acid hydrochloride as compared to the number of participants with neurotoxicity observed in the placebo control group

Analysis population: Stratum 2 with a \>= grade 2 neurotoxicity

Groups in this outcome

Arm I Glutamic Acid

Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). glutamic acid: Given orally 3 times daily

Arm II Placebo

Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). placebo: Given orally 3 times daily

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 I Glutamic Acid79
Arm II Placebo88

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I Glutamic Acid21Not reportedNot reportedNot reportedNot reported
Arm II Placebo25Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        25
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    2. group Id
      OG001
      value
      88
    units
    Participants
description
Number of participants with neurotoxicity observed treated with l-glutamic acid hydrochloride as compared to the number of participants with neurotoxicity observed in the placebo control group
groups
  1. description
    Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). glutamic acid: Given orally 3 times daily
    id
    OG000
    title
    Arm I Glutamic Acid
  2. description
    Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). placebo: Given orally 3 times daily
    id
    OG001
    title
    Arm II Placebo
param Type
COUNT_OF_PARTICIPANTS
population Description
Stratum 2 with a \>= grade 2 neurotoxicity
reporting Status
POSTED
time Frame
10 weeks
title
Number of Participants With Neurotoxicity Observed
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice