Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02739594 · OUTCOME

Number of Events of Osteonecrosis of Jaw for Each Participant

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
MEAN
Unit
events of osteonecrosis of jaw
Interval / dispersion
Standard Deviation
Time frame
From Baseline to end of study (up to Week 96)

What was measured

The number of events of osteonecrosis of jaw was averaged across all participants, including those participants who did not experience the event during the study.

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 events of osteonecrosis of jaw · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibandronate0.00.0Not reportedNot reportedNot reported
Zoledronate0.00.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0
        value
        0.0
      2. group Id
        OG001
        spread
        0.0
        value
        0.0
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      40
    units
    Participants
description
The number of events of osteonecrosis of jaw was averaged across all participants, including those participants who did not experience the event during the study.
dispersion Type
Standard Deviation
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
MEAN
population Description
ITT Population.
reporting Status
POSTED
time Frame
From Baseline to end of study (up to Week 96)
title
Number of Events of Osteonecrosis of Jaw for Each Participant
type
SECONDARY
unit Of Measure
events of osteonecrosis of jaw

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

Preserved source evidence · Not medical advice