<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="7119015">
  <adverse_event_report>
    <yyqq>09Q3</yyqq>
    <isr>6362090</isr>
    <initial_followup_code>i</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6362090-9</image>
    <event_date></event_date>
    <manufacturer_date>2009-09-16</manufacturer_date>
    <fda_date>2009-09-18</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>phhy2009br39867</manufacturer_number>
    <manufacturer_sending>novartis pharmaceutical corporation</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>m</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2009-09-18</report_date>
    <reporter_occupation>cn</reporter_occupation>
    <death_date>2009-08-10</death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>brazil</reporter_country>
    <outcome outcome_code="de"/>
    <outcome outcome_code="ho"/>
    <reaction reaction_preferred_term="cerebrovascular accident"/>
    <reaction reaction_preferred_term="ischaemia"/>
    <reaction reaction_preferred_term="lung infection"/>
    <reaction reaction_preferred_term="pneumonia"/>
    <reaction reaction_preferred_term="sepsis"/>
    <drug_datum>
      <drug_sequence>1012271376</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>exelon</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>transdermal</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>22083</nda_number>
      <therapy>
        <start_date></start_date>
        <end_date>2009-03-01</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012271377</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>exelon</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>transdermal</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>022083</nda_number>
      <therapy>
        <start_date>2009-03-01</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012271378</drug_sequence>
      <role_code>c</role_code>
      <drug_name>zyprexa</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_indication indication_preferred_term="hallucination"/>
      <therapy>
        <start_date>2009-02-01</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012271379</drug_sequence>
      <role_code>c</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>
      <drug_indication indication_preferred_term="hallucination"/>
      <therapy>
        <start_date>2009-02-01</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
  </adverse_event_report>
</adverse_event_case>
