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NCT00872521 · OUTCOME

Overall Response Rate (ORR) Stratified by Protein Expression (Cyclin D1).

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 (Cyclin D1).

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 Cyclin D1 expression

Positive

Participants with Cyclin D1 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
Negative59
Positive25

Reported measurements

Cyclin D1 Non Responder
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Negative11Not reportedNot reportedNot reportedNot reported
Positive5Not reportedNot reportedNot reportedNot reported
Cyclin D1 Responder
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Negative48Not reportedNot reportedNot reportedNot reported
Positive20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        5
    title
    Cyclin D1 Non Responder
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        48
      2. group Id
        OG001
        value
        20
    title
    Cyclin D1 Responder
denoms
  1. counts
    1. group Id
      OG000
      value
      59
    2. group Id
      OG001
      value
      25
    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 (Cyclin D1).
groups
  1. description
    Participants without Cyclin D1 expression
    id
    OG000
    title
    Negative
  2. description
    Participants with Cyclin D1 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 (Cyclin D1).
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice