<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="3157181">
  <adverse_event_report>
    <yyqq>98Q4</yyqq>
    <isr>3148857</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>3148857-9</image>
    <event_date></event_date>
    <manufacturer_date>1998-08-28</manufacturer_date>
    <fda_date>1998-10-28</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>HOAFF-41072</manufacturer_number>
    <manufacturer_sending>Janssen Research Foundation</manufacturer_sending>
    <age>32.0</age>
    <age_units>YR</age_units>
    <gender></gender>
    <is_electronic_submission>false</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date></report_date>
    <reporter_occupation></reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified>false</manufacturer_notified>
    <confidentiality_status>false</confidentiality_status>
    <reporter_country></reporter_country>
    <outcome outcome_code="DE"/>
    <reaction reaction_preferred_term="Death"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="LIT"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1000631822</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Risperdal</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000648848</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Antidepress. Tricyclic (Antidepress. Tricyclic)</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000648849</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Valproic Acid (Valproic Acid)</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>98Q4</yyqq>
    <isr>3148865</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>3148865-8</image>
    <event_date></event_date>
    <manufacturer_date>1998-08-28</manufacturer_date>
    <fda_date>1998-10-28</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>HOAFF-41072</manufacturer_number>
    <manufacturer_sending>Janssen Research Foundation</manufacturer_sending>
    <age>32.0</age>
    <age_units>YR</age_units>
    <gender></gender>
    <is_electronic_submission>false</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date></report_date>
    <reporter_occupation></reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified>false</manufacturer_notified>
    <confidentiality_status>false</confidentiality_status>
    <reporter_country></reporter_country>
    <outcome outcome_code="DE"/>
    <reaction reaction_preferred_term="Death"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="LIT"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1000631842</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Risperdal</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>VAGINAL</administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000670183</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Antidepress. Tricyclic (Antidepress. Ticyclic)</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000670184</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Valproic Acid</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>98Q4</yyqq>
    <isr>3150120</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>1</followup_sequence>
    <image>3150120-7</image>
    <event_date></event_date>
    <manufacturer_date>1998-08-28</manufacturer_date>
    <fda_date>1998-10-30</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>HOAFF-41072</manufacturer_number>
    <manufacturer_sending>Janssen Research Foundation</manufacturer_sending>
    <age>32.0</age>
    <age_units>YR</age_units>
    <gender>NS</gender>
    <is_electronic_submission>false</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date></report_date>
    <reporter_occupation></reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified>false</manufacturer_notified>
    <confidentiality_status>false</confidentiality_status>
    <reporter_country></reporter_country>
    <outcome outcome_code="DE"/>
    <reaction reaction_preferred_term="Death"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="LIT"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1000636158</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Risperdal</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000645399</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Antidepress.Tricyclic</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000645409</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Valproic Acid</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
  </adverse_event_report>
</adverse_event_case>
