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NCT00985959 · OUTCOME

Median Time to First Response - Phase II

A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT) · Source last updated 2013-12-02

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
up to 54 weeks

What was measured

Time to first response is the duartion of time required to achieve first response to treatment

Analysis population: Full analysis set: All participants who received at least one dose of the study medication.

Groups in this outcome

Phase II - JNJ-26866138 1.3 mg/m2 Group

JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles

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

Analysis denominator · Participants

GroupSource count
Phase II - JNJ-26866138 1.3 mg/m2 Group86

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II - JNJ-26866138 1.3 mg/m2 Group51Not reported4382Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        43
        upper Limit
        82
        value
        51
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    units
    Participants
description
Time to first response is the duartion of time required to achieve first response to treatment
dispersion Type
95% Confidence Interval
groups
  1. description
    JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
    id
    OG000
    title
    Phase II - JNJ-26866138 1.3 mg/m2 Group
param Type
MEDIAN
population Description
Full analysis set: All participants who received at least one dose of the study medication.
reporting Status
POSTED
time Frame
up to 54 weeks
title
Median Time to First Response - Phase II
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice