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NCT00104650 · OUTCOME

Time to First Skeletal Related Event

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

Time from study day 1 to first 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. Median was not reached in at least 1 treatment arm. In lieu of the median, the number of subject who experienced a skeletal related event is presented.

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

GroupSource count
Bisphosphonate IV Q4W35
Denosumab 180 mg Q12W35
Denosumab 180 mg Q4W38

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bisphosphonate IV Q4W6Not reportedNot reportedNot reportedNot reported
Denosumab 180 mg Q12W4Not reportedNot reportedNot reportedNot reported
Denosumab 180 mg Q4W2Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.018
    ci Pct Value
    95
    ci Upper Limit
    1.465
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.105
    param Type
    Hazard Ratio (HR)
    param Value
    0.162
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.143
    ci Pct Value
    95
    ci Upper Limit
    2.289
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.430
    param Type
    Hazard Ratio (HR)
    param Value
    0.573
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.018
    ci Pct Value
    95
    ci Upper Limit
    1.465
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.105
    param Type
    Hazard Ratio (HR)
    param Value
    0.162
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.143
    ci Pct Value
    95
    ci Upper Limit
    2.289
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.430
    param Type
    Hazard Ratio (HR)
    param Value
    0.573
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    2. group Id
      OG001
      value
      35
    3. group Id
      OG002
      value
      38
    units
    Participants
description
Time from study day 1 to first 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
  1. description
    Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
    id
    OG000
    title
    Bisphosphonate IV Q4W
  2. description
    Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
    id
    OG001
    title
    Denosumab 180 mg Q12W
  3. 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. Median was not reached in at least 1 treatment arm. In lieu of the median, the number of subject who experienced a skeletal related event is presented.
reporting Status
POSTED
time Frame
Day 1, week 25
title
Time to First Skeletal Related Event
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice