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NCT00104650 · OUTCOME

Duration of Maintaining uNTX (Corrected by Creatinine) < 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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 1, week 25

What was measured

Time from the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) to the 1st occurrence of uNTx above 50 nmol BCE/mmol up to week 25. For participants who remained below 50 nmol BCE/mmol, the time is censored at the time of last evaluation of uNTx up to week 25.

Analysis population: Treatment Phase Primary Analysis Subset. Median was not reached in at least 1 treatment arm. In lieu of the median, the number of subject whose uNTX (corrected by creatinine) less than 50nmol/mmol 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 Q12W33
Denosumab 180 mg Q4W36

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bisphosphonate IV Q4W25Not reportedNot reportedNot reportedNot reported
Denosumab 180 mg Q12W32Not reportedNot reportedNot reportedNot reported
Denosumab 180 mg Q4W35Not 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
    0.110
    ci Pct Value
    95
    ci Upper Limit
    0.687
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.006
    param Type
    Hazard Ratio (HR)
    param Value
    0.274
    statistical Comment
    Adjusted for cancer type stratification factor and screening uNTx level
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.076
    ci Pct Value
    95
    ci Upper Limit
    0.523
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.199
    statistical Comment
    Adjusted for cancer type stratification factor and screening uNTx level
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.110
    ci Pct Value
    95
    ci Upper Limit
    0.687
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.006
    param Type
    Hazard Ratio (HR)
    param Value
    0.274
    statistical Comment
    Adjusted for cancer type stratification factor and screening uNTx level
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.076
    ci Pct Value
    95
    ci Upper Limit
    0.523
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.199
    statistical Comment
    Adjusted for cancer type stratification factor and screening uNTx level
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        32
      3. group Id
        OG002
        value
        35
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    2. group Id
      OG001
      value
      33
    3. group Id
      OG002
      value
      36
    units
    Participants
description
Time from the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) to the 1st occurrence of uNTx above 50 nmol BCE/mmol up to week 25. For participants who remained below 50 nmol BCE/mmol, the time is censored at the time of last evaluation of uNTx up to week 25.
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
Treatment Phase Primary Analysis Subset. Median was not reached in at least 1 treatment arm. In lieu of the median, the number of subject whose uNTX (corrected by creatinine) less than 50nmol/mmol is presented.
reporting Status
POSTED
time Frame
Day 1, week 25
title
Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice