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NCT02580058 · OUTCOME

Overall Survival (OS)

A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200) · Source last updated 2023-07-10

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
From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018).

What was measured

OS is defined as the time from the date of randomization to the date of death due to any cause. OS time was summarized by treatment arm using the Kaplan-Meier method.

Analysis population: The primary analyses of OS were performed based on the Full Analysis Set (FAS). The FAS included all participants who were randomized.

Groups in this outcome

Avelumab

Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.

Avelumab + PLD

Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.

Pegylated Liposomal Doxorubicin (PLD)

PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.

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

Analysis denominator · Participants

GroupSource count
Avelumab188
Avelumab + PLD188
Pegylated Liposomal Doxorubicin (PLD)190

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Avelumab11.8Not reported8.914.1Not reported
Avelumab + PLD15.7Not reported12.718.7Not reported
Pegylated Liposomal Doxorubicin (PLD)13.1Not reported11.815.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.867
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.497
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8253
    param Type
    Hazard Ratio (HR)
    param Value
    1.14
    statistical Comment
    1-sided
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.672
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.179
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2082
    param Type
    Hazard Ratio (HR)
    param Value
    0.89
    statistical Comment
    1-sided
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.867
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.497
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8253
    param Type
    Hazard Ratio (HR)
    param Value
    1.14
    statistical Comment
    1-sided
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.672
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.179
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2082
    param Type
    Hazard Ratio (HR)
    param Value
    0.89
    statistical Comment
    1-sided
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.9
        upper Limit
        14.1
        value
        11.8
      2. group Id
        OG001
        lower Limit
        12.7
        upper Limit
        18.7
        value
        15.7
      3. group Id
        OG002
        lower Limit
        11.8
        upper Limit
        15.5
        value
        13.1
denoms
  1. counts
    1. group Id
      OG000
      value
      188
    2. group Id
      OG001
      value
      188
    3. group Id
      OG002
      value
      190
    units
    Participants
description
OS is defined as the time from the date of randomization to the date of death due to any cause. OS time was summarized by treatment arm using the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
    id
    OG000
    title
    Avelumab
  2. description
    Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
    id
    OG001
    title
    Avelumab + PLD
  3. description
    PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
    id
    OG002
    title
    Pegylated Liposomal Doxorubicin (PLD)
param Type
MEDIAN
population Description
The primary analyses of OS were performed based on the Full Analysis Set (FAS). The FAS included all participants who were randomized.
reporting Status
POSTED
time Frame
From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018).
title
Overall Survival (OS)
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice