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NCT00321620 · OUTCOME

Time to the First On-Study SRE (Superiority)

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer · Source last updated 2018-08-29

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 40.5 months

What was measured

Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported.

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 subcutaneously 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

GroupSource count
Zoledronic Acid951
Denosumab950

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Zoledronic Acid521.0Not reported456.0592.0Not reported
Denosumab629.0Not reported573.00757.00Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.71
    ci Pct Value
    95
    ci Upper Limit
    0.95
    estimate Comment
    Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0085
    param Type
    Hazard Ratio (HR)
    param Value
    0.82
    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
  1. ci Lower Limit
    0.71
    ci Pct Value
    95
    ci Upper Limit
    0.95
    estimate Comment
    Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0085
    param Type
    Hazard Ratio (HR)
    param Value
    0.82
    statistical Comment
    P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        456.0
        upper Limit
        592.0
        value
        521.0
      2. group Id
        OG001
        lower Limit
        573.00
        upper Limit
        757.00
        value
        629.0
denoms
  1. counts
    1. group Id
      OG000
      value
      951
    2. group Id
      OG001
      value
      950
    units
    Participants
description
Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported.
dispersion Type
95% Confidence Interval
groups
  1. description
    Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
    id
    OG000
    title
    Zoledronic Acid
  2. description
    Denosumab 120 mg subcutaneously 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 40.5 months
title
Time to the First On-Study SRE (Superiority)
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice