NCT00622505 · OUTCOME

Percentage of Participants Who Experienced Spinal Cord Compression

Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants · Source last updated 2021-05-26

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: Years 1 and 2

What was measured

Spinal cord compression is caused by the impingement of a tumor on the spinal cord and is associated with neurologic impairment and/or back pain.

Analysis population: ITT analysis set included all participants who were enrolled in the study. Number analyzed signifies the number of participants with data available for analysis at given time point.

Groups in this outcome

Zoledronic Acid Every 12 Weeks

Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \<50 nmol/mmol creatinine).

Zoledronic Acid Every 4 Weeks or 12 Weeks

Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \<50 nmol/mmol creatinine, respectively).

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

Analysis denominator · Participants

Group	Source count
Zoledronic Acid Every 12 Weeks	79
Zoledronic Acid Every 4 Weeks or 12 Weeks	42

Reported measurements

Year 1

Analysis denominator · Participants

Group	Source count
Zoledronic Acid Every 12 Weeks	79
Zoledronic Acid Every 4 Weeks or 12 Weeks	42

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Zoledronic Acid Every 12 Weeks	0.00	Not reported	NA	NA	Upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.
Zoledronic Acid Every 4 Weeks or 12 Weeks	0.07	Not reported	0.00	0.15	Not reported

Year 2

Analysis denominator · Participants

Group	Source count
Zoledronic Acid Every 12 Weeks	63
Zoledronic Acid Every 4 Weeks or 12 Weeks	38

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Zoledronic Acid Every 12 Weeks	0.00	Not reported	NA	NA	Upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.
Zoledronic Acid Every 4 Weeks or 12 Weeks	0.00	Not reported	NA	NA	Upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.

Complete source fields

classes

categories
measurements
comment
Upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
0.00
group Id
OG001
lower Limit
0.00
upper Limit
0.15
value
0.07
denoms
counts
group Id
OG000
value
79
group Id
OG001
value
42
units
Participants
title
Year 1
categories
measurements
comment
Upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
0.00
comment
Upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.
group Id
OG001
lower Limit
NA
upper Limit
NA
value
0.00
denoms
counts
group Id
OG000
value
63
group Id
OG001
value
38
units
Participants
title
Year 2

denoms

counts
group Id
OG000
value
79
group Id
OG001
value
42
units
Participants

description

Spinal cord compression is caused by the impingement of a tumor on the spinal cord and is associated with neurologic impairment and/or back pain.

dispersion Type

95% Confidence Interval

groups

description
Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \<50 nmol/mmol creatinine).
id
OG000
title
Zoledronic Acid Every 12 Weeks
description
Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \<50 nmol/mmol creatinine, respectively).
id
OG001
title
Zoledronic Acid Every 4 Weeks or 12 Weeks

param Type

NUMBER

population Description

ITT analysis set included all participants who were enrolled in the study. Number analyzed signifies the number of participants with data available for analysis at given time point.

reporting Status

POSTED

time Frame

Years 1 and 2

title

Percentage of Participants Who Experienced Spinal Cord Compression

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice