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NCT00622505 · OUTCOME

Time to First SRE on Study

Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants · Source last updated 2021-05-26

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

Measure
MEDIAN
Unit
years
Interval / dispersion
95% Confidence Interval
Time frame
Up to 2 years

What was measured

The time to first SRE is defined as the date of enrollment to the date of the first occurrence of any SRE on the study. SRE includes pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM. Participants who drop-out was treated as censored observations. Time to first SRE on the study was assessed by the Kaplan-Meier method.

Analysis population: ITT analysis set included all participants who were enrolled in this study.

Groups in this outcome

Zoledronic Acid Every 12 Weeks

Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \<50 nmol/mmol creatinine).

Zoledronic Acid Every 4 Weeks or 12 Weeks

Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \<50 nmol/mmol creatinine, respectively).

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 Every 12 Weeks79
Zoledronic Acid Every 4 Weeks or 12 Weeks42

Reported measurements

Source class 1
Values in years · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Zoledronic Acid Every 12 WeeksNANot reportedNANAThe median and 95 % CI was not estimable because there were too few events (low incidence of observed SREs) to calculate the median and 95 % CI.
Zoledronic Acid Every 4 Weeks or 12 WeeksNANot reportedNANAThe median and 95 % CI was not estimable because there were too few events (low incidence of observed SREs) to calculate the median and 95 % CI.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The median and 95 % CI was not estimable because there were too few events (low incidence of observed SREs) to calculate the median and 95 % CI.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        The median and 95 % CI was not estimable because there were too few events (low incidence of observed SREs) to calculate the median and 95 % CI.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    2. group Id
      OG001
      value
      42
    units
    Participants
description
The time to first SRE is defined as the date of enrollment to the date of the first occurrence of any SRE on the study. SRE includes pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM. Participants who drop-out was treated as censored observations. Time to first SRE on the study was assessed by the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \<50 nmol/mmol creatinine).
    id
    OG000
    title
    Zoledronic Acid Every 12 Weeks
  2. description
    Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \<50 nmol/mmol creatinine, respectively).
    id
    OG001
    title
    Zoledronic Acid Every 4 Weeks or 12 Weeks
param Type
MEDIAN
population Description
ITT analysis set included all participants who were enrolled in this study.
reporting Status
POSTED
time Frame
Up to 2 years
title
Time to First SRE on Study
type
SECONDARY
unit Of Measure
years

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

Preserved source evidence · Not medical advice