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NCT00104104 · OUTCOME

The Number of Participants With Disease Progression

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
24 Months

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 Infusion28Not reportedNot reportedNot reportedNot reported
30 - Minute Infusion20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        20
denoms
  1. counts
    1. group Id
      OG000
      value
      85
    2. group Id
      OG001
      value
      84
    units
    Participants
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
24 Months
title
The Number of Participants With Disease Progression
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice