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NCT02580058 · OUTCOME

Change From Baseline in Vital Signs - Pulse Rate

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
MEAN
Unit
bpm
Interval / dispersion
Standard Deviation
Time frame
From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.

What was measured

Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.

Analysis population: 'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set with at least a baseline and post-baseline assessment at the visit.

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
Avelumab187
Avelumab + PLD182
Pegylated Liposomal Doxorubicin (PLD)177

Reported measurements

Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Avelumab180
Avelumab + PLD170
Pegylated Liposomal Doxorubicin (PLD)142
Values in bpm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab2.99.95Not reportedNot reportedNot reported
Avelumab + PLD1.812.10Not reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)3.510.70Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Avelumab164
Avelumab + PLD167
Pegylated Liposomal Doxorubicin (PLD)155
Values in bpm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab2.610.92Not reportedNot reportedNot reported
Avelumab + PLD2.911.18Not reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)1.79.71Not reportedNot reportedNot reported
Cycle 2 Day 15

Analysis denominator · Participants

GroupSource count
Avelumab138
Avelumab + PLD157
Pegylated Liposomal Doxorubicin (PLD)124
Values in bpm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab2.911.19Not reportedNot reportedNot reported
Avelumab + PLD3.511.79Not reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)3.211.54Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Avelumab104
Avelumab + PLD141
Pegylated Liposomal Doxorubicin (PLD)106
Values in bpm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab2.410.00Not reportedNot reportedNot reported
Avelumab + PLD2.111.78Not reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)1.411.14Not reportedNot reportedNot reported
Cycle 3 Day 15

Analysis denominator · Participants

GroupSource count
Avelumab95
Avelumab + PLD128
Pegylated Liposomal Doxorubicin (PLD)84
Values in bpm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab3.012.23Not reportedNot reportedNot reported
Avelumab + PLD1.411.44Not reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)2.410.41Not reportedNot reportedNot reported
End of Treatment

Analysis denominator · Participants

GroupSource count
Avelumab146
Avelumab + PLD138
Pegylated Liposomal Doxorubicin (PLD)136
Values in bpm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avelumab7.714.27Not reportedNot reportedNot reported
Avelumab + PLD7.413.70Not reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)5.714.10Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.95
        value
        2.9
      2. group Id
        OG001
        spread
        12.10
        value
        1.8
      3. group Id
        OG002
        spread
        10.70
        value
        3.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        180
      2. group Id
        OG001
        value
        170
      3. group Id
        OG002
        value
        142
      units
      Participants
    title
    Cycle 1 Day 15
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.92
        value
        2.6
      2. group Id
        OG001
        spread
        11.18
        value
        2.9
      3. group Id
        OG002
        spread
        9.71
        value
        1.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        164
      2. group Id
        OG001
        value
        167
      3. group Id
        OG002
        value
        155
      units
      Participants
    title
    Cycle 2 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.19
        value
        2.9
      2. group Id
        OG001
        spread
        11.79
        value
        3.5
      3. group Id
        OG002
        spread
        11.54
        value
        3.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        138
      2. group Id
        OG001
        value
        157
      3. group Id
        OG002
        value
        124
      units
      Participants
    title
    Cycle 2 Day 15
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.00
        value
        2.4
      2. group Id
        OG001
        spread
        11.78
        value
        2.1
      3. group Id
        OG002
        spread
        11.14
        value
        1.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        104
      2. group Id
        OG001
        value
        141
      3. group Id
        OG002
        value
        106
      units
      Participants
    title
    Cycle 3 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.23
        value
        3.0
      2. group Id
        OG001
        spread
        11.44
        value
        1.4
      3. group Id
        OG002
        spread
        10.41
        value
        2.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        128
      3. group Id
        OG002
        value
        84
      units
      Participants
    title
    Cycle 3 Day 15
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.27
        value
        7.7
      2. group Id
        OG001
        spread
        13.70
        value
        7.4
      3. group Id
        OG002
        spread
        14.10
        value
        5.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        138
      3. group Id
        OG002
        value
        136
      units
      Participants
    title
    End of Treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      187
    2. group Id
      OG001
      value
      182
    3. group Id
      OG002
      value
      177
    units
    Participants
description
Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.
dispersion Type
Standard Deviation
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
MEAN
population Description
'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set with at least a baseline and post-baseline assessment at the visit.
reporting Status
POSTED
time Frame
From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
title
Change From Baseline in Vital Signs - Pulse Rate
type
SECONDARY
unit Of Measure
bpm

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Preserved source evidence · Not medical advice