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NCT01345019 · OUTCOME

Percentage of Participants With an On-study Skeletal Related Event

Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma · Source last updated 2022-11-08

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.

What was measured

A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.

Analysis population: All randomized participants

Groups in this outcome

Zoledronic Acid

Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.

Denosumab

Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.

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 Acid859
Denosumab859

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Zoledronic Acid44.6Not reported41.347.9Not reported
Denosumab43.8Not reported40.547.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        41.3
        upper Limit
        47.9
        value
        44.6
      2. group Id
        OG001
        lower Limit
        40.5
        upper Limit
        47.1
        value
        43.8
denoms
  1. counts
    1. group Id
      OG000
      value
      859
    2. group Id
      OG001
      value
      859
    units
    Participants
description
A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.
    id
    OG000
    title
    Zoledronic Acid
  2. description
    Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.
    id
    OG001
    title
    Denosumab
param Type
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.
title
Percentage of Participants With an On-study Skeletal Related Event
type
PRIMARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice