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NCT02739594 · OUTCOME

Percentage of Participants With Osteonecrosis of Jaw

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From Baseline to end of study (up to Week 96)

What was measured

The percentage of participants with at least 1 event of osteonecrosis of jaw during the study was reported.

Analysis population: ITT Population.

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
Ibandronate41
Zoledronate40

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ibandronate0.0Not reported0.08.6Not reported
Zoledronate0.0Not reported0.08.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        8.6
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        8.8
        value
        0.0
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      40
    units
    Participants
description
The percentage of participants with at least 1 event of osteonecrosis of jaw during the study was reported.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
ITT Population.
reporting Status
POSTED
time Frame
From Baseline to end of study (up to Week 96)
title
Percentage of Participants With Osteonecrosis of Jaw
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice