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NCT01353222 · OUTCOME

Overall Survival

DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma · Source last updated 2017-05-25

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months)

What was measured

Overall survival is defined as the time from randomization to death due to any cause. \*This study was terminated early due to administrative reasons.

Analysis population: Intent to Treat (ITT) population. \*This study was terminated early due to administrative reasons.

Groups in this outcome

DN24-02

DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.

Standard of Care

Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population. Standard of Care: Standard of care

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
DN24-0270
Standard of Care72

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DN24-0217.2Not reported0.142.4Not reported
Standard of Care18Not reported0.340.2Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.679
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.918
    estimate Comment
    Cox regression model with treatment as the independent variable, stratified by randomization strata. Hazard ratio with control as reference.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6188
    param Type
    Hazard Ratio (HR)
    param Value
    1.141
    statistical Method
    From a stratified log-rank test, stratif
Complete source fields
analyses
  1. ci Lower Limit
    0.679
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.918
    estimate Comment
    Cox regression model with treatment as the independent variable, stratified by randomization strata. Hazard ratio with control as reference.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6188
    param Type
    Hazard Ratio (HR)
    param Value
    1.141
    statistical Method
    From a stratified log-rank test, stratif
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        42.4
        value
        17.2
      2. group Id
        OG001
        lower Limit
        0.3
        upper Limit
        40.2
        value
        18
denoms
  1. counts
    1. group Id
      OG000
      value
      70
    2. group Id
      OG001
      value
      72
    units
    Participants
description
Overall survival is defined as the time from randomization to death due to any cause. \*This study was terminated early due to administrative reasons.
dispersion Type
Full Range
groups
  1. description
    DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
    id
    OG000
    title
    DN24-02
  2. description
    Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population. Standard of Care: Standard of care
    id
    OG001
    title
    Standard of Care
param Type
MEDIAN
population Description
Intent to Treat (ITT) population. \*This study was terminated early due to administrative reasons.
reporting Status
POSTED
time Frame
Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months)
title
Overall Survival
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice