<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="7055272">
  <adverse_event_report>
    <yyqq>09Q3</yyqq>
    <isr>6274153</isr>
    <initial_followup_code>f</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6274153-7</image>
    <event_date>2009-01-09</event_date>
    <manufacturer_date>2009-07-15</manufacturer_date>
    <fda_date>2009-07-20</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>phhy2009de01597</manufacturer_number>
    <manufacturer_sending>novartis pharmaceuticals corp.</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>f</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight>53.0</weight>
    <weight_units>KG</weight_units>
    <report_date>2009-07-20</report_date>
    <reporter_occupation>ph</reporter_occupation>
    <death_date>2009-01-14</death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>germany</reporter_country>
    <outcome outcome_code="de"/>
    <outcome outcome_code="ho"/>
    <outcome outcome_code="lt"/>
    <outcome outcome_code="ot"/>
    <reaction reaction_preferred_term="abdominal distension"/>
    <reaction reaction_preferred_term="abdominal tenderness"/>
    <reaction reaction_preferred_term="bladder disorder"/>
    <reaction reaction_preferred_term="death"/>
    <reaction reaction_preferred_term="dementia"/>
    <reaction reaction_preferred_term="faecaloma"/>
    <reaction reaction_preferred_term="gastrointestinal sounds abnormal"/>
    <reaction reaction_preferred_term="ileus"/>
    <reaction reaction_preferred_term="nausea"/>
    <reaction reaction_preferred_term="pancreatitis"/>
    <reaction reaction_preferred_term="subileus"/>
    <reaction reaction_preferred_term="vascular encephalopathy"/>
    <reaction reaction_preferred_term="white blood cell count increased"/>
    <drug_datum>
      <drug_sequence>1011911871</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>exelon</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>020823</nda_number>
      <drug_indication indication_preferred_term="parkinson's disease"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011911872</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>exelon</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>020823</nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011911873</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>clozapine</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>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011911874</drug_sequence>
      <role_code>ss</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>
    <drug_datum>
      <drug_sequence>1011911875</drug_sequence>
      <role_code>c</role_code>
      <drug_name>omeprazole</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>1011911876</drug_sequence>
      <role_code>c</role_code>
      <drug_name>pipamperone</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>1011911877</drug_sequence>
      <role_code>c</role_code>
      <drug_name>carbidopa</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>1011911878</drug_sequence>
      <role_code>c</role_code>
      <drug_name>ergenyl</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>1011911879</drug_sequence>
      <role_code>c</role_code>
      <drug_name>ergenyl</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>1011911880</drug_sequence>
      <role_code>c</role_code>
      <drug_name>domperidone</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>1011911881</drug_sequence>
      <role_code>c</role_code>
      <drug_name>stalevo 100</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>1011911882</drug_sequence>
      <role_code>c</role_code>
      <drug_name>stalevo 100</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>1011911883</drug_sequence>
      <role_code>c</role_code>
      <drug_name>stalevo 100</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>1011911884</drug_sequence>
      <role_code>c</role_code>
      <drug_name>distraneurin</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_case>
