Drug adverse event reports (FAERS)

Death

Drugs: PADCEV, PEMBROLIZUMAB

SeriousDeathReport 27325205
Safetyreportversion
1
Safetyreportid
27325205
Primarysourcecountry
JP
Occurcountry
JP
Transmissiondateformat
102
Transmissiondate
20261010
Reporttype
1
Serious
1
Seriousnessdeath
1
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
2
Receivedateformat
102
Receivedate
20260930
Receiptdateformat
102
Receiptdate
20260930
Fulfillexpeditecriteria
1
Companynumb
JP-ASTELLAS-2026-AER-054147
Primarysource
Reportercountry
JP
Qualification
2
Sender
Sendertype
6
Senderorganization
ASTELLAS
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
8
Patientonsetageunit
800
Patientagegroup
6
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Death
    Reactionoutcome
    5
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    PADCEV
    Drugauthorizationnumb
    761137
    Drugstructuredosagenumb
    1.25
    Drugstructuredosageunit
    007
    Drugseparatedosagenumb
    1
    Drugdosagetext
    FULL DOSE, ABOUT 3 COURSES
    Drugindication
    Bladder cancer
    Actiondrug
    6
    Drugrecurreadministration
    3
    Drugadditional
    4
    Activesubstance
    Activesubstancename
    ENFORTUMAB VEDOTIN-EJFV
    Harmonized identifiers (openFDA)
    Application number
    BLA761137
    Brand name
    PADCEV EJFV
    Generic name
    ENFORTUMAB VEDOTIN
    Manufacturer name
    SEAGEN INC.
    Product NDC
    51144-020, 51144-030
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    INTRAVENOUS
    Substance name
    ENFORTUMAB VEDOTIN
    RxCUI
    2268311, 2268315, 2268317, 2268319
    SPL ID
    e8e304ca-8a56-4869-96e2-427ee4a1fe3c
    SPL set ID
    b5631d3e-4604-4363-8f20-11dfc5a4a8ed
    Package NDC
    51144-020-01, 51144-030-01
    UNII
    DLE8519RWM
  2. Drugcharacterization
    2
    Medicinalproduct
    PEMBROLIZUMAB
    Drugseparatedosagenumb
    1
    Drugindication
    Bladder cancer
    Actiondrug
    5
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    PEMBROLIZUMAB
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20260901
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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.