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NCT02580058 · OUTCOME

Number of Participants With Laboratory 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

The number of participants with following laboratory abnormalities meeting any of the Grades 1 to 4 classified according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading version 4.03 were summarized: hematology (anemia, lymphocyte count decreased, neutrophil count decreased; and platelet count decreased) and chemistry laboratory tests (creatinine increased; serum amylase increased and lipase increased).

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 can be evaluated for CTCAE criteria for each parameter in each treatment group.

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

Anemia

Analysis denominator · Participants

GroupSource count
Avelumab186
Avelumab + PLD178
Pegylated Liposomal Doxorubicin (PLD)172
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab135Not reportedNot reportedNot reportedNot reported
Avelumab + PLD155Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)144Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased

Analysis denominator · Participants

GroupSource count
Avelumab185
Avelumab + PLD178
Pegylated Liposomal Doxorubicin (PLD)171
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab89Not reportedNot reportedNot reportedNot reported
Avelumab + PLD148Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)107Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased

Analysis denominator · Participants

GroupSource count
Avelumab185
Avelumab + PLD177
Pegylated Liposomal Doxorubicin (PLD)172
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab26Not reportedNot reportedNot reportedNot reported
Avelumab + PLD80Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)62Not reportedNot reportedNot reportedNot reported
Platelet count decreased

Analysis denominator · Participants

GroupSource count
Avelumab186
Avelumab + PLD178
Pegylated Liposomal Doxorubicin (PLD)172
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab33Not reportedNot reportedNot reportedNot reported
Avelumab + PLD48Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)50Not reportedNot reportedNot reportedNot reported
Creatinine increased

Analysis denominator · Participants

GroupSource count
Avelumab186
Avelumab + PLD178
Pegylated Liposomal Doxorubicin (PLD)172
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab154Not reportedNot reportedNot reportedNot reported
Avelumab + PLD151Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)120Not reportedNot reportedNot reportedNot reported
Serum amylase increased

Analysis denominator · Participants

GroupSource count
Avelumab180
Avelumab + PLD172
Pegylated Liposomal Doxorubicin (PLD)161
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab43Not reportedNot reportedNot reportedNot reported
Avelumab + PLD35Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)27Not reportedNot reportedNot reportedNot reported
Lipase increased

Analysis denominator · Participants

GroupSource count
Avelumab175
Avelumab + PLD173
Pegylated Liposomal Doxorubicin (PLD)159
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab27Not reportedNot reportedNot reportedNot reported
Avelumab + PLD33Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)21Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        135
      2. group Id
        OG001
        value
        155
      3. group Id
        OG002
        value
        144
    denoms
    1. counts
      1. group Id
        OG000
        value
        186
      2. group Id
        OG001
        value
        178
      3. group Id
        OG002
        value
        172
      units
      Participants
    title
    Anemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        89
      2. group Id
        OG001
        value
        148
      3. group Id
        OG002
        value
        107
    denoms
    1. counts
      1. group Id
        OG000
        value
        185
      2. group Id
        OG001
        value
        178
      3. group Id
        OG002
        value
        171
      units
      Participants
    title
    Lymphocyte count decreased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        80
      3. group Id
        OG002
        value
        62
    denoms
    1. counts
      1. group Id
        OG000
        value
        185
      2. group Id
        OG001
        value
        177
      3. group Id
        OG002
        value
        172
      units
      Participants
    title
    Neutrophil count decreased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        48
      3. group Id
        OG002
        value
        50
    denoms
    1. counts
      1. group Id
        OG000
        value
        186
      2. group Id
        OG001
        value
        178
      3. group Id
        OG002
        value
        172
      units
      Participants
    title
    Platelet count decreased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        154
      2. group Id
        OG001
        value
        151
      3. group Id
        OG002
        value
        120
    denoms
    1. counts
      1. group Id
        OG000
        value
        186
      2. group Id
        OG001
        value
        178
      3. group Id
        OG002
        value
        172
      units
      Participants
    title
    Creatinine increased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        35
      3. group Id
        OG002
        value
        27
    denoms
    1. counts
      1. group Id
        OG000
        value
        180
      2. group Id
        OG001
        value
        172
      3. group Id
        OG002
        value
        161
      units
      Participants
    title
    Serum amylase increased
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        33
      3. group Id
        OG002
        value
        21
    denoms
    1. counts
      1. group Id
        OG000
        value
        175
      2. group Id
        OG001
        value
        173
      3. group Id
        OG002
        value
        159
      units
      Participants
    title
    Lipase increased
denoms
  1. counts
    1. group Id
      OG000
      value
      187
    2. group Id
      OG001
      value
      182
    3. group Id
      OG002
      value
      177
    units
    Participants
description
The number of participants with following laboratory abnormalities meeting any of the Grades 1 to 4 classified according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading version 4.03 were summarized: hematology (anemia, lymphocyte count decreased, neutrophil count decreased; and platelet count decreased) and chemistry laboratory tests (creatinine increased; serum amylase increased and lipase increased).
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 can be evaluated for CTCAE criteria for each parameter in each treatment group.
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 Laboratory Abnormalities
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice