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NCT00872521 · OUTCOME

Overall Response Rate (ORR) Stratified by Protein Expression (p53)

A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma · Source last updated 2014-05-16

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
84 days

What was measured

Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (p53).

Analysis population: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.

Groups in this outcome

Negative

Participants without p53 expression

Positive

Participants with p53 expression

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

Analysis denominator · Participants

GroupSource count
Negative75
Positive14

Reported measurements

p53 Non Responder
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Negative14Not reportedNot reportedNot reportedNot reported
Positive3Not reportedNot reportedNot reportedNot reported
p53 Responder
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Negative61Not reportedNot reportedNot reportedNot reported
Positive11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        3
    title
    p53 Non Responder
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        11
    title
    p53 Responder
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      14
    units
    Participants
description
Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (p53).
groups
  1. description
    Participants without p53 expression
    id
    OG000
    title
    Negative
  2. description
    Participants with p53 expression
    id
    OG001
    title
    Positive
param Type
NUMBER
population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.
reporting Status
POSTED
time Frame
84 days
title
Overall Response Rate (ORR) Stratified by Protein Expression (p53)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice