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NCT02580058 · OUTCOME

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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 the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months); based on cutoff date: 13 July 2022.

What was measured

An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; progression of the malignancy under study. Treatment emergent AEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period.

Analysis population: Analysis is based on the safety analysis set. The safety analysis set included all participants who received at least 1 dose of study treatment.

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

TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab180Not reportedNot reportedNot reportedNot reported
Avelumab + PLD180Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)173Not reportedNot reportedNot reportedNot reported
Treatment emergent SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab72Not reportedNot reportedNot reportedNot reported
Avelumab + PLD74Not reportedNot reportedNot reportedNot reported
Pegylated Liposomal Doxorubicin (PLD)51Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        180
      2. group Id
        OG001
        value
        180
      3. group Id
        OG002
        value
        173
    title
    TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        72
      2. group Id
        OG001
        value
        74
      3. group Id
        OG002
        value
        51
    title
    Treatment emergent SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      187
    2. group Id
      OG001
      value
      182
    3. group Id
      OG002
      value
      177
    units
    Participants
description
An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; progression of the malignancy under study. Treatment emergent AEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period.
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
Analysis is based on the safety analysis set. The safety analysis set included all participants who received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
From the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months); based on cutoff date: 13 July 2022.
title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice