NCT00330759 · OUTCOME

Time to First On-Study Skeletal-Related Event (Superiority)

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma. · Source last updated 2022-11-07

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

Measure: MEDIAN
Unit: Days
Interval / dispersion: 95% Confidence Interval
Time frame: up to 33 months

What was measured

Time to first on-study skeletal-related event (SRE) using a test for superiority. Median was estimated using the Kaplan-Meier method.

Analysis population: Full Analysis Set, composed of all randomized participants.

Groups in this outcome

Zoledronic Acid

Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks

Denosumab

Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks

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	890
Denosumab	886

Reported measurements

Source class 1

Values in Days · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Zoledronic Acid	496.0	Not reported	371.00	589.00	Not reported
Denosumab	625.0	Not reported	456.00	NA	Upper limit could not be estimated due to the low number of events.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.71
ci Pct Value
95
ci Upper Limit
0.98
estimate Comment
Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.060
param Type
Hazard Ratio (HR)
param Value
0.84
statistical Comment
P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.
statistical Method
Regression, Cox

Complete source fields

analyses

ci Lower Limit
0.71
ci Pct Value
95
ci Upper Limit
0.98
estimate Comment
Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.060
param Type
Hazard Ratio (HR)
param Value
0.84
statistical Comment
P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.
statistical Method
Regression, Cox

classes

categories
measurements
group Id
OG000
lower Limit
371.00
upper Limit
589.00
value
496.0
comment
Upper limit could not be estimated due to the low number of events.
group Id
OG001
lower Limit
456.00
upper Limit
NA
value
625.0

denoms

counts
group Id
OG000
value
890
group Id
OG001
value
886
units
Participants

description

Time to first on-study skeletal-related event (SRE) using a test for superiority. Median was estimated using the Kaplan-Meier method.

dispersion Type

95% Confidence Interval

groups

description
Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
id
OG000
title
Zoledronic Acid
description
Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
id
OG001
title
Denosumab

param Type

MEDIAN

population Description

Full Analysis Set, composed of all randomized participants.

reporting Status

POSTED

time Frame

up to 33 months

title

Time to First On-Study Skeletal-Related Event (Superiority)

type

SECONDARY

unit Of Measure

Days

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice