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NCT00104650 · OUTCOME

Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol

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
MEDIAN
Unit
Days
Interval / dispersion
Inter-Quartile Range
Time frame
Day 1, week 25

What was measured

Kaplan-Meier estimate of the median time from enrollment to the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) up to week 25. For participants whose uNTx does not go below 50 nM BCE/mM creatinine, the time is censored at time of last evaluation of uNTx by week 25.

Analysis population: All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.

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 Q12W33
Denosumab 180 mg Q4W36

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Bisphosphonate IV Q4W65Not reported8141Not reported
Denosumab 180 mg Q12W9Not reported411Not reported
Denosumab 180 mg Q4W10Not reported811Not reported

Source statistical analyses

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

  1. ci Lower Limit
    2.01
    ci Pct Value
    95
    ci Upper Limit
    7.15
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    3.79
    statistical Comment
    Stratified by cancer type and screening uNTx level
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
  2. ci Lower Limit
    2.23
    ci Pct Value
    95
    ci Upper Limit
    8.36
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    4.32
    statistical Comment
    Stratified by cancer type and screening uNTx level
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    2.01
    ci Pct Value
    95
    ci Upper Limit
    7.15
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    3.79
    statistical Comment
    Stratified by cancer type and screening uNTx level
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
  2. ci Lower Limit
    2.23
    ci Pct Value
    95
    ci Upper Limit
    8.36
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    4.32
    statistical Comment
    Stratified by cancer type and screening uNTx level
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8
        upper Limit
        141
        value
        65
      2. group Id
        OG001
        lower Limit
        4
        upper Limit
        11
        value
        9
      3. group Id
        OG002
        lower Limit
        8
        upper Limit
        11
        value
        10
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    2. group Id
      OG001
      value
      33
    3. group Id
      OG002
      value
      36
    units
    Participants
description
Kaplan-Meier estimate of the median time from enrollment to the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) up to week 25. For participants whose uNTx does not go below 50 nM BCE/mM creatinine, the time is censored at time of last evaluation of uNTx by week 25.
dispersion Type
Inter-Quartile Range
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
MEDIAN
population Description
All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.
reporting Status
POSTED
time Frame
Day 1, week 25
title
Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol
type
SECONDARY
unit Of Measure
Days

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Preserved source evidence · Not medical advice