<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="3180991">
  <adverse_event_report>
    <yyqq>98Q4</yyqq>
    <isr>3171158</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>3171158-X</image>
    <event_date>1998-11-11</event_date>
    <manufacturer_date>1998-12-03</manufacturer_date>
    <fda_date>1998-12-16</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>JAKYO-41647</manufacturer_number>
    <manufacturer_sending>Janssen Research Foundation</manufacturer_sending>
    <age>41.0</age>
    <age_units>YR</age_units>
    <gender>M</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"/>
    <outcome outcome_code="HO"/>
    <reaction reaction_preferred_term="C-Reactive Protein Increased"/>
    <reaction reaction_preferred_term="Decreased Activity"/>
    <reaction reaction_preferred_term="Depressed Level Of Consciousness"/>
    <reaction reaction_preferred_term="Disseminated Intravascular Coagulation"/>
    <reaction reaction_preferred_term="Flatulence"/>
    <reaction reaction_preferred_term="Hyperpyrexia Malignant"/>
    <reaction reaction_preferred_term="Hypoxia"/>
    <reaction reaction_preferred_term="Malaise"/>
    <reaction reaction_preferred_term="Multi-Organ Failure"/>
    <reaction reaction_preferred_term="Muscle Rigidity"/>
    <reaction reaction_preferred_term="Neuroleptic Malignant Syndrome"/>
    <reaction reaction_preferred_term="Renal Failure Nos"/>
    <reaction reaction_preferred_term="Sweating Increased"/>
    <reaction reaction_preferred_term="Vomiting Nos"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1000707930</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Risperdal</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>N</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1998-11-06</start_date>
        <end_date>1998-11-11</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000718954</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Methylphenidate Hydrochloride</drug_name>
      <validated_or_verbatim>1</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>
      <therapy>
        <start_date>1998-11-06</start_date>
        <end_date>1998-11-11</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000718956</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Depakene</drug_name>
      <validated_or_verbatim>1</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>
      <therapy>
        <start_date>1997-06-09</start_date>
        <end_date>1998-11-11</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000718960</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Pravastatin Sodium</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>
      <therapy>
        <start_date>1997-08-16</start_date>
        <end_date>1998-11-11</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000718962</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Cetraxate Hydrochloride</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>
      <therapy>
        <start_date>1998-11-06</start_date>
        <end_date>1998-11-11</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
  </adverse_event_report>
</adverse_event_case>
