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NCT02580058 · OUTCOME

Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 1 of Cycle 1, Day 1 of each subsequent cycle, end of treatment/withdrawal visit and the 30, 60 and 90 days safety follow up visits, based on cutoff date: 19 September 2018.

What was measured

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) is a 30 question survey and includes 5 functional domain subscales, global health status/quality of life, disease/treatment related symptoms, and the perceived financial impact of disease. Higher scores are reflective of a greater presence of symptoms.

Analysis population: The analysis is based on the FAS. The FAS included all participants who were randomized. 'Number Analyzed' in represents number of participants in the FAS with a score at baseline and post-baseline.

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
Avelumab152
Avelumab + PLD166
Pegylated Liposomal Doxorubicin (PLD)148

Reported measurements

Source class 1

Deterioration

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab46Not reportedNot reportedNot reportedNot reported
Avelumab + PLD65Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)46Not reportedNot reportedNot reportedNot reported

Improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab23Not reportedNot reportedNot reportedNot reported
Avelumab + PLD20Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)26Not reportedNot reportedNot reportedNot reported

Stable

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab83Not reportedNot reportedNot reportedNot reported
Avelumab + PLD81Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)76Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        46
      2. group Id
        OG001
        value
        65
      3. group Id
        OG002
        value
        46
      title
      Deterioration
    2. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        26
      title
      Improved
    3. measurements
      1. group Id
        OG000
        value
        83
      2. group Id
        OG001
        value
        81
      3. group Id
        OG002
        value
        76
      title
      Stable
denoms
  1. counts
    1. group Id
      OG000
      value
      152
    2. group Id
      OG001
      value
      166
    3. group Id
      OG002
      value
      148
    units
    Participants
description
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) is a 30 question survey and includes 5 functional domain subscales, global health status/quality of life, disease/treatment related symptoms, and the perceived financial impact of disease. Higher scores are reflective of a greater presence of symptoms.
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
COUNT_OF_PARTICIPANTS
population Description
The analysis is based on the FAS. The FAS included all participants who were randomized. 'Number Analyzed' in represents number of participants in the FAS with a score at baseline and post-baseline.
reporting Status
POSTED
time Frame
Day 1 of Cycle 1, Day 1 of each subsequent cycle, end of treatment/withdrawal visit and the 30, 60 and 90 days safety follow up visits, based on cutoff date: 19 September 2018.
title
Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice