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NCT02739594 · OUTCOME

Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)

Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma · Source last updated 2016-07-22

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

Measure
MEDIAN
Unit
percent change
Interval / dispersion
Full Range
Time frame
Baseline and Weeks 44, 92

What was measured

The percent change in B-NAG was calculated as \[Week 44 or 92 B-NAG minus Baseline B-NAG\] divided by Baseline B-NAG, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.

Analysis population: ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.

Groups in this outcome

Ibandronate

Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.

Zoledronate

Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.

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

Analysis denominator · Participants

GroupSource count
Ibandronate38
Zoledronate37

Reported measurements

Week 44
Values in percent change · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Ibandronate-15.7Not reported-86355Not reported
Zoledronate10.6Not reported-94156Not reported
Week 92
Values in percent change · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Ibandronate-17.2Not reported-78355Not reported
Zoledronate9.3Not reported-94125Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -86
        upper Limit
        355
        value
        -15.7
      2. group Id
        OG001
        lower Limit
        -94
        upper Limit
        156
        value
        10.6
    title
    Week 44
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -78
        upper Limit
        355
        value
        -17.2
      2. group Id
        OG001
        lower Limit
        -94
        upper Limit
        125
        value
        9.3
    title
    Week 92
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      37
    units
    Participants
description
The percent change in B-NAG was calculated as \[Week 44 or 92 B-NAG minus Baseline B-NAG\] divided by Baseline B-NAG, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.
dispersion Type
Full Range
groups
  1. description
    Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
    id
    OG000
    title
    Ibandronate
  2. description
    Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
    id
    OG001
    title
    Zoledronate
param Type
MEDIAN
population Description
ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint.
reporting Status
POSTED
time Frame
Baseline and Weeks 44, 92
title
Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)
type
SECONDARY
unit Of Measure
percent change

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

Preserved source evidence · Not medical advice