NCT00104650 · OUTCOME

Skeletal Related Events

Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates · Source last updated 2011-01-24

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

Measure: NUMBER
Unit: Participants
Interval / dispersion: Not reported
Time frame: Day 1, week 25

What was measured

Skeletal Related Event (SRE), defined as \>1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).

Analysis population: All participants exposed to investigational product during the treatment phase.

Groups in this outcome

Bisphosphonate IV Q4W

Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)

Denosumab 180 mg Q12W

Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)

Denosumab 180 mg Q4W

Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)

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
Bisphosphonate IV Q4W	35
Denosumab 180 mg Q12W	35
Denosumab 180 mg Q4W	38

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bisphosphonate IV Q4W	6	Not reported	Not reported	Not reported	Not reported
Denosumab 180 mg Q12W	4	Not reported	Not reported	Not reported	Not reported
Denosumab 180 mg Q4W	2	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
0.05
ci Pct Value
95
ci Upper Limit
1.44
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Odds Ratio (OR)
param Value
0.26
tested Non Inferiority
false
ci Lower Limit
0.08
ci Pct Value
95
ci Upper Limit
1.76
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Odds Ratio (OR)
param Value
0.36
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
0.05
ci Pct Value
95
ci Upper Limit
1.44
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Odds Ratio (OR)
param Value
0.26
tested Non Inferiority
false
ci Lower Limit
0.08
ci Pct Value
95
ci Upper Limit
1.76
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Odds Ratio (OR)
param Value
0.36
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
value
6
group Id
OG001
value
4
group Id
OG002
value
2

denoms

counts
group Id
OG000
value
35
group Id
OG001
value
35
group Id
OG002
value
38
units
Participants

description

Skeletal Related Event (SRE), defined as \>1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).

groups

description
Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
id
OG000
title
Bisphosphonate IV Q4W
description
Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
id
OG001
title
Denosumab 180 mg Q12W
description
Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
id
OG002
title
Denosumab 180 mg Q4W

param Type

NUMBER

population Description

All participants exposed to investigational product during the treatment phase.

reporting Status

POSTED

time Frame

Day 1, week 25

title

Skeletal Related Events

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice