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NCT00381680 · OUTCOME

Frequency and Severity of Adverse Effects

Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia · Source last updated 2024-03-26

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 107 weeks

What was measured

Percentage of patients who developed at least 1 episode of grade 2 to 4 neuropathy.

Analysis population: The total number of patients for CC or CT genotype is 81 and for high-risk CEP72 genotype is 18. No related by arm data were provided.

Groups in this outcome

All Patients

This analysis looks at all eligible patients with CC or CT genotypes as well as all eligible patients with the high-risk CEP72 genotype (TT at rs924607).

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

Analysis denominator · Participants

GroupSource count
All Patients99

Reported measurements

CC or CT genotype

Analysis denominator · Participants

GroupSource count
All Patients81
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients17.3Not reported10.127.6Not reported
High-risk CEP72 genotype (TT at rs924607)

Analysis denominator · Participants

GroupSource count
All Patients18
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients44.4Not reported22.468.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.1
        upper Limit
        27.6
        value
        17.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        81
      units
      Participants
    title
    CC or CT genotype
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.4
        upper Limit
        68.7
        value
        44.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      units
      Participants
    title
    High-risk CEP72 genotype (TT at rs924607)
denoms
  1. counts
    1. group Id
      OG000
      value
      99
    units
    Participants
description
Percentage of patients who developed at least 1 episode of grade 2 to 4 neuropathy.
dispersion Type
95% Confidence Interval
groups
  1. description
    This analysis looks at all eligible patients with CC or CT genotypes as well as all eligible patients with the high-risk CEP72 genotype (TT at rs924607).
    id
    OG000
    title
    All Patients
param Type
NUMBER
population Description
The total number of patients for CC or CT genotype is 81 and for high-risk CEP72 genotype is 18. No related by arm data were provided.
reporting Status
POSTED
time Frame
Up to 107 weeks
title
Frequency and Severity of Adverse Effects
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice