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NCT00171925 · OUTCOME

Days of Progression Free Survival

Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I · Source last updated 2012-04-11

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

Measure
MEAN
Unit
Days
Interval / dispersion
Standard Error
Time frame
48 months

What was measured

Progression-free survival was defined as time from date of randomization to death from any cause or one of the following events: * progression to stage II or III according to Salmon \& Durie classification * skeletal related events (pathologic fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or hypercalcemia) * unequivocal progression of osteolytic lesions (at least a 20% increase in the largest diameter of one existing osteolytic lesion which is measured in at least one dimension as 20 mm with conventional techniques), determined radiologically.

Analysis population: Intent to Treat Population

Groups in this outcome

Zoledronic Acid (ZOL446)

Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.

Control

No Treatment with study medication.

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

Analysis denominator · Participants

GroupSource count
Zoledronic Acid (ZOL446)71
Control69

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Zoledronic Acid (ZOL446)1078.159.53Not reportedNot reportedNot reported
Control992.8061.83Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        59.53
        value
        1078.1
      2. group Id
        OG001
        spread
        61.83
        value
        992.80
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    2. group Id
      OG001
      value
      69
    units
    Participants
description
Progression-free survival was defined as time from date of randomization to death from any cause or one of the following events: * progression to stage II or III according to Salmon \& Durie classification * skeletal related events (pathologic fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or hypercalcemia) * unequivocal progression of osteolytic lesions (at least a 20% increase in the largest diameter of one existing osteolytic lesion which is measured in at least one dimension as 20 mm with conventional techniques), determined radiologically.
dispersion Type
Standard Error
groups
  1. description
    Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
    id
    OG000
    title
    Zoledronic Acid (ZOL446)
  2. description
    No Treatment with study medication.
    id
    OG001
    title
    Control
param Type
MEAN
population Description
Intent to Treat Population
reporting Status
POSTED
time Frame
48 months
title
Days of Progression Free Survival
type
PRIMARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice