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NCT00366106 · OUTCOME

Incidence of Treatment-emergent Peripheral Neuropathy

Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma · Source last updated 2012-04-06

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
Every 4 weeks from start of treatment until end of treatment

Groups in this outcome

Treatment Group

All subjects received bortezomib 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m\^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.

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

Analysis denominator · Participants

GroupSource count
Treatment Group32

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Group11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
groups
  1. description
    All subjects received bortezomib 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m\^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
    id
    OG000
    title
    Treatment Group
param Type
NUMBER
reporting Status
POSTED
time Frame
Every 4 weeks from start of treatment until end of treatment
title
Incidence of Treatment-emergent Peripheral Neuropathy
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice