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NCT00104104 · OUTCOME

The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months

A Multiple Myeloma Trial in Patients With Bone Metastases · Source last updated 2011-06-29

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
Baseline and 24 Months

What was measured

Serum Creatinine was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.

Analysis population: Safety Population; enrolled patients who received at least one dose of study medication.

Groups in this outcome

15 - Minute Infusion

Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.

30 - Minute Infusion

Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.

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

Analysis denominator · Participants

GroupSource count
15 - Minute Infusion85
30 - Minute Infusion84

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
15 - Minute Infusion24Not reported0.532.13Not reported
30 - Minute Infusion23Not reported0.532.13Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.53
        upper Limit
        2.13
        value
        24
      2. group Id
        OG001
        lower Limit
        0.53
        upper Limit
        2.13
        value
        23
denoms
  1. counts
    1. group Id
      OG000
      value
      85
    2. group Id
      OG001
      value
      84
    units
    Participants
description
Serum Creatinine was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.
groups
  1. description
    Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
    id
    OG000
    title
    15 - Minute Infusion
  2. description
    Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
    id
    OG001
    title
    30 - Minute Infusion
param Type
NUMBER
population Description
Safety Population; enrolled patients who received at least one dose of study medication.
reporting Status
POSTED
time Frame
Baseline and 24 Months
title
The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice