<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="3174491">
  <adverse_event_report>
    <yyqq>98Q4</yyqq>
    <isr>3169845</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>3169845-2</image>
    <event_date>1998-01-01</event_date>
    <manufacturer_date>1998-11-30</manufacturer_date>
    <fda_date>1998-12-14</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>110000</manufacturer_number>
    <manufacturer_sending>Global Development Hoffmann-La Roche Inc.</manufacturer_sending>
    <age>68.0</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"/>
    <reaction reaction_preferred_term="Confusion"/>
    <reaction reaction_preferred_term="Diarrhoea Nos"/>
    <reaction reaction_preferred_term="Markedly Reduced Food Intake"/>
    <reaction reaction_preferred_term="Muscle Rigidity"/>
    <reaction reaction_preferred_term="Parkinsonism"/>
    <reaction reaction_preferred_term="Pneumonia Nos"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="SDY"/>
    <report_source report_source_code="HP"/>
    <report_source report_source_code="OTH"/>
    <drug_datum>
      <drug_sequence>1000701314</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Tasmar</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>1997-11-24</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000703776</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Madopar</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>1000703777</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Movergan</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>1000703778</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Pk-Merz</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>98Q4</yyqq>
    <isr>3169858</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>1</followup_sequence>
    <image>3169858-0</image>
    <event_date>1998-02-28</event_date>
    <manufacturer_date>1998-12-08</manufacturer_date>
    <fda_date>1998-12-14</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>110000</manufacturer_number>
    <manufacturer_sending>Global Development Hoffmann-La Roche Inc.</manufacturer_sending>
    <age>68.0</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"/>
    <reaction reaction_preferred_term="Akinesia"/>
    <reaction reaction_preferred_term="Confusion"/>
    <reaction reaction_preferred_term="Diarrhoea Nos"/>
    <reaction reaction_preferred_term="Muscle Rigidity"/>
    <reaction reaction_preferred_term="Parkinsonism"/>
    <reaction reaction_preferred_term="Pneumonia Nos"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="SDY"/>
    <report_source report_source_code="HP"/>
    <report_source report_source_code="OTH"/>
    <drug_datum>
      <drug_sequence>1000701353</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Tasmar</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>1997-11-24</start_date>
        <end_date>1998-01-15</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000705605</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Madopar</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>1000705607</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Movergan</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>1000705608</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Pk-Merz</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>98Q4</yyqq>
    <isr>3173492</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>2</followup_sequence>
    <image>3173492-6</image>
    <event_date>1998-02-28</event_date>
    <manufacturer_date>1998-12-15</manufacturer_date>
    <fda_date>1998-12-24</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>110000</manufacturer_number>
    <manufacturer_sending>Global Development Hoffmann-La Roche Inc.</manufacturer_sending>
    <age>68.0</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"/>
    <reaction reaction_preferred_term="Condition Aggravated"/>
    <reaction reaction_preferred_term="Confusion"/>
    <reaction reaction_preferred_term="Dehydration"/>
    <reaction reaction_preferred_term="Diarrhoea Nos"/>
    <reaction reaction_preferred_term="Pneumonia Nos"/>
    <reaction reaction_preferred_term="Pyrexia"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="SDY"/>
    <report_source report_source_code="HP"/>
    <report_source report_source_code="OTH"/>
    <drug_datum>
      <drug_sequence>1000719706</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Tasmar</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>1997-11-24</start_date>
        <end_date>1998-01-15</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000721104</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Madopar (Benserazide / Levodopa)</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>1000721105</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Movergan (Selegiline Hydrochloride)</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>1000721106</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Pk - Merz (Amantadine Sulfate)</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>3184275</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>3</followup_sequence>
    <image>3184275-5</image>
    <event_date>1998-02-28</event_date>
    <manufacturer_date>1999-01-11</manufacturer_date>
    <fda_date>1999-01-22</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>110000</manufacturer_number>
    <manufacturer_sending>Global Development Hoffmann-La Roche Inc.</manufacturer_sending>
    <age>75.0</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"/>
    <reaction reaction_preferred_term="Abdominal Distension"/>
    <reaction reaction_preferred_term="Agitation"/>
    <reaction reaction_preferred_term="Benign Prostatic Hyperplasia"/>
    <reaction reaction_preferred_term="Blood Bilirubin Increased"/>
    <reaction reaction_preferred_term="Bronchitis Acute Nos"/>
    <reaction reaction_preferred_term="Bronchopneumonia Nos"/>
    <reaction reaction_preferred_term="Cardiac Failure Nos"/>
    <reaction reaction_preferred_term="Cardiomegaly Nos"/>
    <reaction reaction_preferred_term="Condition Aggravated"/>
    <reaction reaction_preferred_term="Confusion"/>
    <reaction reaction_preferred_term="Dehydration"/>
    <reaction reaction_preferred_term="Diarrhoea Nos"/>
    <reaction reaction_preferred_term="Disorientation"/>
    <reaction reaction_preferred_term="Dry Skin"/>
    <reaction reaction_preferred_term="Gastrointestinal Disorder Nos"/>
    <reaction reaction_preferred_term="Infection Nos"/>
    <reaction reaction_preferred_term="Muscle Rigidity"/>
    <reaction reaction_preferred_term="Pneumonia Nos"/>
    <reaction reaction_preferred_term="Pyrexia"/>
    <reaction reaction_preferred_term="Renal Disorder Nos"/>
    <reaction reaction_preferred_term="Respiratory Failure (Exc Neonatal)"/>
    <reaction reaction_preferred_term="Sedation"/>
    <reaction reaction_preferred_term="Weakness"/>
    <reaction reaction_preferred_term="White Blood Cell Count Increased"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="SDY"/>
    <report_source report_source_code="HP"/>
    <report_source report_source_code="OTH"/>
    <drug_datum>
      <drug_sequence>1000761726</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Tasmar</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>1997-11-24</start_date>
        <end_date>1998-01-15</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000762264</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Madopar (Benserazide/Levodopa)</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>1000762266</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Movergan (Selegiline Hydrochloride)</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>1000762267</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Pk-Merz (Amantadine Sulfate)</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>1000762268</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Digimerck Minor (Digitoxin)</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>1000762271</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Clozapine</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>
