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NCT02580058 · OUTCOME

Number of Participants With Electrocardiogram (ECG) Abnormalities

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
From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.

What was measured

Categorical summarization ECG criteria were as follows: 1) QT interval, QTcB, QTcF and QTcP: increase from baseline \>30 ms or 60 ms; absolute value \> 450 ms, \>480 ms and \> 500 ms; 2) heart rate (HR): change from baseline \>=20 bpm and absolute value \<=50 bpm or \>=120 bpm; 3) PR interval: absolute value \>=220 ms and increase from baseline \>=20 ms; 4) QRS: \>= 120 ms.

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 who had a at least 1 post-baseline ECG assessment performed.

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

QT increase from baseline >30 ms

Analysis denominator · Participants

GroupSource count
Avelumab183
Avelumab + PLD176
Pegylated Liposomal Doxorubicin (PLD)169
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab26Not reportedNot reportedNot reportedNot reported
Avelumab + PLD40Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)47Not reportedNot reportedNot reportedNot reported
QT increase from baseline >60 ms

Analysis denominator · Participants

GroupSource count
Avelumab183
Avelumab + PLD176
Pegylated Liposomal Doxorubicin (PLD)169
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab5Not reportedNot reportedNot reportedNot reported
Avelumab + PLD9Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)4Not reportedNot reportedNot reportedNot reported
QT >450 ms

Analysis denominator · Participants

GroupSource count
Avelumab183
Avelumab + PLD176
Pegylated Liposomal Doxorubicin (PLD)169
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab6Not reportedNot reportedNot reportedNot reported
Avelumab + PLD10Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)5Not reportedNot reportedNot reportedNot reported
QT >480 ms

Analysis denominator · Participants

GroupSource count
Avelumab183
Avelumab + PLD176
Pegylated Liposomal Doxorubicin (PLD)169
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab1Not reportedNot reportedNot reportedNot reported
Avelumab + PLD2Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)2Not reportedNot reportedNot reportedNot reported
QT >500 ms

Analysis denominator · Participants

GroupSource count
Avelumab183
Avelumab + PLD176
Pegylated Liposomal Doxorubicin (PLD)169
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab1Not reportedNot reportedNot reportedNot reported
Avelumab + PLD1Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)1Not reportedNot reportedNot reportedNot reported
QTcB increase from baseline >30 ms

Analysis denominator · Participants

GroupSource count
Avelumab154
Avelumab + PLD153
Pegylated Liposomal Doxorubicin (PLD)143
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab33Not reportedNot reportedNot reportedNot reported
Avelumab + PLD36Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)22Not reportedNot reportedNot reportedNot reported
QTcB increase from baseline >60 ms

Analysis denominator · Participants

GroupSource count
Avelumab154
Avelumab + PLD153
Pegylated Liposomal Doxorubicin (PLD)143
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab9Not reportedNot reportedNot reportedNot reported
Avelumab + PLD7Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)8Not reportedNot reportedNot reportedNot reported
QTcB >450 ms

Analysis denominator · Participants

GroupSource count
Avelumab161
Avelumab + PLD160
Pegylated Liposomal Doxorubicin (PLD)145
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab56Not reportedNot reportedNot reportedNot reported
Avelumab + PLD63Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)45Not reportedNot reportedNot reportedNot reported
QTcB >480 ms

Analysis denominator · Participants

GroupSource count
Avelumab161
Avelumab + PLD160
Pegylated Liposomal Doxorubicin (PLD)145
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab9Not reportedNot reportedNot reportedNot reported
Avelumab + PLD19Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)9Not reportedNot reportedNot reportedNot reported
QTcB >500 ms

Analysis denominator · Participants

GroupSource count
Avelumab161
Avelumab + PLD160
Pegylated Liposomal Doxorubicin (PLD)145
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab5Not reportedNot reportedNot reportedNot reported
Avelumab + PLD9Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)5Not reportedNot reportedNot reportedNot reported
QTcF increase from baseline >30 ms

Analysis denominator · Participants

GroupSource count
Avelumab154
Avelumab + PLD153
Pegylated Liposomal Doxorubicin (PLD)143
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab19Not reportedNot reportedNot reportedNot reported
Avelumab + PLD24Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)13Not reportedNot reportedNot reportedNot reported
QTcF increase from baseline >60 ms

Analysis denominator · Participants

GroupSource count
Avelumab154
Avelumab + PLD153
Pegylated Liposomal Doxorubicin (PLD)143
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab6Not reportedNot reportedNot reportedNot reported
Avelumab + PLD5Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)5Not reportedNot reportedNot reportedNot reported
QTcF >450 ms

Analysis denominator · Participants

GroupSource count
Avelumab161
Avelumab + PLD160
Pegylated Liposomal Doxorubicin (PLD)145
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab18Not reportedNot reportedNot reportedNot reported
Avelumab + PLD27Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)14Not reportedNot reportedNot reportedNot reported
QTcF >480 ms

Analysis denominator · Participants

GroupSource count
Avelumab161
Avelumab + PLD160
Pegylated Liposomal Doxorubicin (PLD)145
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab4Not reportedNot reportedNot reportedNot reported
Avelumab + PLD8Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)5Not reportedNot reportedNot reportedNot reported
QTcF >500 ms

Analysis denominator · Participants

GroupSource count
Avelumab161
Avelumab + PLD160
Pegylated Liposomal Doxorubicin (PLD)145
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab3Not reportedNot reportedNot reportedNot reported
Avelumab + PLD2Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)4Not reportedNot reportedNot reportedNot reported
QTcP increase from baseline >30 ms

Analysis denominator · Participants

GroupSource count
Avelumab154
Avelumab + PLD153
Pegylated Liposomal Doxorubicin (PLD)143
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab17Not reportedNot reportedNot reportedNot reported
Avelumab + PLD23Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)12Not reportedNot reportedNot reportedNot reported
QTcP increase from baseline >60 ms

Analysis denominator · Participants

GroupSource count
Avelumab154
Avelumab + PLD153
Pegylated Liposomal Doxorubicin (PLD)143
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab6Not reportedNot reportedNot reportedNot reported
Avelumab + PLD5Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)4Not reportedNot reportedNot reportedNot reported
QTcP >450 ms

Analysis denominator · Participants

GroupSource count
Avelumab161
Avelumab + PLD160
Pegylated Liposomal Doxorubicin (PLD)145
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab19Not reportedNot reportedNot reportedNot reported
Avelumab + PLD29Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)17Not reportedNot reportedNot reportedNot reported
QTcP >480 ms

Analysis denominator · Participants

GroupSource count
Avelumab161
Avelumab + PLD160
Pegylated Liposomal Doxorubicin (PLD)145
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab2Not reportedNot reportedNot reportedNot reported
Avelumab + PLD7Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)2Not reportedNot reportedNot reportedNot reported
QTcP >500 ms

Analysis denominator · Participants

GroupSource count
Avelumab161
Avelumab + PLD160
Pegylated Liposomal Doxorubicin (PLD)145
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab1Not reportedNot reportedNot reportedNot reported
Avelumab + PLD2Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)2Not reportedNot reportedNot reportedNot reported
Heart rate <=50 bpm and decrease >= 20 bpm

Analysis denominator · Participants

GroupSource count
Avelumab154
Avelumab + PLD153
Pegylated Liposomal Doxorubicin (PLD)143
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab0Not reportedNot reportedNot reportedNot reported
Avelumab + PLD1Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)0Not reportedNot reportedNot reportedNot reported
Heart rate >=120 bpm and increase >= 20 bpm

Analysis denominator · Participants

GroupSource count
Avelumab154
Avelumab + PLD153
Pegylated Liposomal Doxorubicin (PLD)143
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab5Not reportedNot reportedNot reportedNot reported
Avelumab + PLD5Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)3Not reportedNot reportedNot reportedNot reported
PR >=220 ms and increase from baseline >=20 ms

Analysis denominator · Participants

GroupSource count
Avelumab182
Avelumab + PLD176
Pegylated Liposomal Doxorubicin (PLD)168
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab3Not reportedNot reportedNot reportedNot reported
Avelumab + PLD4Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)2Not reportedNot reportedNot reportedNot reported
QRS >=120 ms

Analysis denominator · Participants

GroupSource count
Avelumab183
Avelumab + PLD176
Pegylated Liposomal Doxorubicin (PLD)169
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab7Not reportedNot reportedNot reportedNot reported
Avelumab + PLD9Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        40
      3. group Id
        OG002
        value
        47
    denoms
    1. counts
      1. group Id
        OG000
        value
        183
      2. group Id
        OG001
        value
        176
      3. group Id
        OG002
        value
        169
      units
      Participants
    title
    QT increase from baseline >30 ms
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        183
      2. group Id
        OG001
        value
        176
      3. group Id
        OG002
        value
        169
      units
      Participants
    title
    QT increase from baseline >60 ms
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        183
      2. group Id
        OG001
        value
        176
      3. group Id
        OG002
        value
        169
      units
      Participants
    title
    QT >450 ms
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        183
      2. group Id
        OG001
        value
        176
      3. group Id
        OG002
        value
        169
      units
      Participants
    title
    QT >480 ms
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        183
      2. group Id
        OG001
        value
        176
      3. group Id
        OG002
        value
        169
      units
      Participants
    title
    QT >500 ms
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        36
      3. group Id
        OG002
        value
        22
    denoms
    1. counts
      1. group Id
        OG000
        value
        154
      2. group Id
        OG001
        value
        153
      3. group Id
        OG002
        value
        143
      units
      Participants
    title
    QTcB increase from baseline >30 ms
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
    denoms
    1. counts
      1. group Id
        OG000
        value
        154
      2. group Id
        OG001
        value
        153
      3. group Id
        OG002
        value
        143
      units
      Participants
    title
    QTcB increase from baseline >60 ms
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        63
      3. group Id
        OG002
        value
        45
    denoms
    1. counts
      1. group Id
        OG000
        value
        161
      2. group Id
        OG001
        value
        160
      3. group Id
        OG002
        value
        145
      units
      Participants
    title
    QTcB >450 ms
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        9
    denoms
    1. counts
      1. group Id
        OG000
        value
        161
      2. group Id
        OG001
        value
        160
      3. group Id
        OG002
        value
        145
      units
      Participants
    title
    QTcB >480 ms
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        161
      2. group Id
        OG001
        value
        160
      3. group Id
        OG002
        value
        145
      units
      Participants
    title
    QTcB >500 ms
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        13
    denoms
    1. counts
      1. group Id
        OG000
        value
        154
      2. group Id
        OG001
        value
        153
      3. group Id
        OG002
        value
        143
      units
      Participants
    title
    QTcF increase from baseline >30 ms
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        154
      2. group Id
        OG001
        value
        153
      3. group Id
        OG002
        value
        143
      units
      Participants
    title
    QTcF increase from baseline >60 ms
denoms
  1. counts
    1. group Id
      OG000
      value
      187
    2. group Id
      OG001
      value
      182
    3. group Id
      OG002
      value
      177
    units
    Participants
description
Categorical summarization ECG criteria were as follows: 1) QT interval, QTcB, QTcF and QTcP: increase from baseline \>30 ms or 60 ms; absolute value \> 450 ms, \>480 ms and \> 500 ms; 2) heart rate (HR): change from baseline \>=20 bpm and absolute value \<=50 bpm or \>=120 bpm; 3) PR interval: absolute value \>=220 ms and increase from baseline \>=20 ms; 4) QRS: \>= 120 ms.
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
'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 who had a at least 1 post-baseline ECG assessment performed.
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
Number of Participants With Electrocardiogram (ECG) Abnormalities
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice