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NCT00171925 · OUTCOME

Number of Patients With Progression by Individual Criteria

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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
48 months

What was measured

Number of patients with progression by individual criteria consisting of Progression of disease overall, Skeletal-related events (including pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or Hypercalcemia), Progression to stage II or III according to Salmon \& Durie classification, and unequivocal progression of osteolytic lesion. Patients are counted separately for every type of progression, but only once for Overall Progression.

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

Progression of disease overall
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zoledronic Acid (ZOL446)19Not reportedNot reportedNot reportedNot reported
Control26Not reportedNot reportedNot reportedNot reported
Skeletal-related events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zoledronic Acid (ZOL446)0Not reportedNot reportedNot reportedNot reported
Control4Not reportedNot reportedNot reportedNot reported
Progression to stage II or III
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zoledronic Acid (ZOL446)17Not reportedNot reportedNot reportedNot reported
Control24Not reportedNot reportedNot reportedNot reported
Unequivocal progression of osteolytic lesion
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zoledronic Acid (ZOL446)3Not reportedNot reportedNot reportedNot reported
Control10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        26
    title
    Progression of disease overall
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
    title
    Skeletal-related events
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        24
    title
    Progression to stage II or III
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        10
    title
    Unequivocal progression of osteolytic lesion
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    2. group Id
      OG001
      value
      69
    units
    Participants
description
Number of patients with progression by individual criteria consisting of Progression of disease overall, Skeletal-related events (including pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or Hypercalcemia), Progression to stage II or III according to Salmon \& Durie classification, and unequivocal progression of osteolytic lesion. Patients are counted separately for every type of progression, but only once for Overall Progression.
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
NUMBER
population Description
Intent to Treat Population
reporting Status
POSTED
time Frame
48 months
title
Number of Patients With Progression by Individual Criteria
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice