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NCT00738530 · OUTCOME

Overall Survival (OS) Duration

A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy · Source last updated 2016-06-23

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline until death (up to 4.25 years)

What was measured

Duration of survival was defined as the time between the date of randomization and date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. Kaplan-Meier estimates were used for analysis.

Analysis population: ITT population included all participants randomized into the study.

Groups in this outcome

Bevacizumab + IFN-Alfa-2A

Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.

Placebo + IFN-Alfa-2A

Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.

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

Analysis denominator · Participants

GroupSource count
Bevacizumab + IFN-Alfa-2A327
Placebo + IFN-Alfa-2A322

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bevacizumab + IFN-Alfa-2A23.3Not reported20.427.0Not reported
Placebo + IFN-Alfa-2A21.3Not reported18.424.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.76
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.10
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3360
    param Type
    Hazard Ratio (HR)
    param Value
    0.91
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.76
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.10
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3360
    param Type
    Hazard Ratio (HR)
    param Value
    0.91
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.4
        upper Limit
        27.0
        value
        23.3
      2. group Id
        OG001
        lower Limit
        18.4
        upper Limit
        24.5
        value
        21.3
denoms
  1. counts
    1. group Id
      OG000
      value
      327
    2. group Id
      OG001
      value
      322
    units
    Participants
description
Duration of survival was defined as the time between the date of randomization and date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. Kaplan-Meier estimates were used for analysis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    id
    OG000
    title
    Bevacizumab + IFN-Alfa-2A
  2. description
    Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    id
    OG001
    title
    Placebo + IFN-Alfa-2A
param Type
MEDIAN
population Description
ITT population included all participants randomized into the study.
reporting Status
POSTED
time Frame
Baseline until death (up to 4.25 years)
title
Overall Survival (OS) Duration
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice