<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="3182570">
  <adverse_event_report>
    <yyqq>98Q4</yyqq>
    <isr>3172692</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>3172692-9</image>
    <event_date>1998-11-21</event_date>
    <manufacturer_date>1998-12-07</manufacturer_date>
    <fda_date>1998-12-21</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>JAKYO-41734</manufacturer_number>
    <manufacturer_sending>Janssen Research Foundation</manufacturer_sending>
    <age>50.0</age>
    <age_units>YR</age_units>
    <gender>F</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="Akathisia"/>
    <reaction reaction_preferred_term="Anxiety Nec"/>
    <reaction reaction_preferred_term="Binocular Eye Movement Disorder Nos"/>
    <reaction reaction_preferred_term="Blister"/>
    <reaction reaction_preferred_term="Blood Creatine Phosphokinase Increased"/>
    <reaction reaction_preferred_term="Blood Myoglobin Increased"/>
    <reaction reaction_preferred_term="Blood Pressure Decreased"/>
    <reaction reaction_preferred_term="Body Temperature Decreased"/>
    <reaction reaction_preferred_term="Cardiac Disorder Nos"/>
    <reaction reaction_preferred_term="Cardiac Fibrillation Nos"/>
    <reaction reaction_preferred_term="Coma Nec"/>
    <reaction reaction_preferred_term="Corneal Reflex Decreased"/>
    <reaction reaction_preferred_term="Cyanosis Nos"/>
    <reaction reaction_preferred_term="Delusion Nos"/>
    <reaction reaction_preferred_term="Diarrhoea Nos"/>
    <reaction reaction_preferred_term="Dyspnoea Nos"/>
    <reaction reaction_preferred_term="Electrocardiogram Abnormal Nos"/>
    <reaction reaction_preferred_term="Gastric Dilatation"/>
    <reaction reaction_preferred_term="Hallucination Nos"/>
    <reaction reaction_preferred_term="Hypotension"/>
    <reaction reaction_preferred_term="Lacrimation Increased"/>
    <reaction reaction_preferred_term="Liver Function Tests Nos Abnormal"/>
    <reaction reaction_preferred_term="Muscle Rigidity"/>
    <reaction reaction_preferred_term="Neck Stiffness"/>
    <reaction reaction_preferred_term="Negativism"/>
    <reaction reaction_preferred_term="Neuroleptic Malignant Syndrome"/>
    <reaction reaction_preferred_term="Pain Nos"/>
    <reaction reaction_preferred_term="Psychotic Disorder Nos"/>
    <reaction reaction_preferred_term="Pupil Fixed"/>
    <reaction reaction_preferred_term="Rash Erythematous"/>
    <reaction reaction_preferred_term="Speech Disorder Nec"/>
    <reaction reaction_preferred_term="Stupor"/>
    <reaction reaction_preferred_term="Suicidal Ideation"/>
    <reaction reaction_preferred_term="Sweating Increased"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1000716186</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>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1998-04-27</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000724008</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Levomepromazine Maleate</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>1998-09-11</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000724011</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Depakene</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000724013</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Diazepam</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000724015</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Triazolam (Triazolam)</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000724016</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Risperdal</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date></start_date>
        <end_date>1998-11-09</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000724017</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Risperdal</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000724018</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Levomepromazine Maleate</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000724019</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Levomepromazine Maleate</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000724023</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Sulpiride (Sulpiride)</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1998-08-28</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000724025</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Sulpiride (Sulpiride)</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>
    <drug_datum>
      <drug_sequence>1000724026</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Flunitrazepam (Flunitrazepam)</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000724027</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Sennoside (Sennosides)</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000724029</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Carbamazepine (Carbamazepine)</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>99Q1</yyqq>
    <isr>3177594</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>1</followup_sequence>
    <image>3177594-X</image>
    <event_date>1998-11-21</event_date>
    <manufacturer_date>1998-12-17</manufacturer_date>
    <fda_date>1999-01-05</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>JAKYO-41734</manufacturer_number>
    <manufacturer_sending>Janssen Research Foundation</manufacturer_sending>
    <age>50.0</age>
    <age_units>YR</age_units>
    <gender>F</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="Acute Circulatory Failure"/>
    <reaction reaction_preferred_term="Akathisia"/>
    <reaction reaction_preferred_term="Anxiety Nec"/>
    <reaction reaction_preferred_term="Apnoea"/>
    <reaction reaction_preferred_term="Blister"/>
    <reaction reaction_preferred_term="Blood Creatine Phosphokinase Increased"/>
    <reaction reaction_preferred_term="Blood Myoglobin Increased"/>
    <reaction reaction_preferred_term="Blood Pressure Decreased"/>
    <reaction reaction_preferred_term="Condition Aggravated"/>
    <reaction reaction_preferred_term="Corneal Reflex Decreased"/>
    <reaction reaction_preferred_term="Cyanosis Nos"/>
    <reaction reaction_preferred_term="Depressed Level Of Consciousness"/>
    <reaction reaction_preferred_term="Diarrhoea Nos"/>
    <reaction reaction_preferred_term="Electrocardiogram Abnormal Nos"/>
    <reaction reaction_preferred_term="Gastric Dilatation"/>
    <reaction reaction_preferred_term="Heart Sounds Abnormal"/>
    <reaction reaction_preferred_term="Liver Function Tests Nos Abnormal"/>
    <reaction reaction_preferred_term="Muscle Rigidity"/>
    <reaction reaction_preferred_term="Mydriasis"/>
    <reaction reaction_preferred_term="Negativism"/>
    <reaction reaction_preferred_term="Neuroleptic Malignant Syndrome"/>
    <reaction reaction_preferred_term="Pain Nos"/>
    <reaction reaction_preferred_term="Rash Erythematous"/>
    <reaction reaction_preferred_term="Respiratory Failure (Exc Neonatal)"/>
    <reaction reaction_preferred_term="Speech Disorder Nec"/>
    <reaction reaction_preferred_term="Staring"/>
    <reaction reaction_preferred_term="Stupor"/>
    <reaction reaction_preferred_term="Suicidal Ideation"/>
    <reaction reaction_preferred_term="Sweating Increased"/>
    <reaction reaction_preferred_term="Ventricular Fibrillation"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1000734303</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>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1998-04-27</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
      <therapy>
        <start_date></start_date>
        <end_date>1998-11-09</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000738544</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Levomepromazine Maleate</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>1998-09-11</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
      <therapy>
        <start_date></start_date>
        <end_date>1998-11-09</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000738558</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Sulpiride</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>1998-08-28</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
      <therapy>
        <start_date></start_date>
        <end_date>1998-11-09</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000738559</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Depakene</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000738560</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Diazepam</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000738561</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Triazolam</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000738562</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Flunitrazepam</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000738563</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Sennoside</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000738564</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Carbamazepine</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
  </adverse_event_report>
</adverse_event_case>
