<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="7008816">
  <adverse_event_report>
    <yyqq>09Q2</yyqq>
    <isr>6211425</isr>
    <initial_followup_code>i</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6211425-6</image>
    <event_date></event_date>
    <manufacturer_date>2009-05-22</manufacturer_date>
    <fda_date>2009-06-02</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>nl-eli_lilly_and_company-nl200905004432</manufacturer_number>
    <manufacturer_sending>eli lilly and company</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>2009-05-27</report_date>
    <reporter_occupation>md</reporter_occupation>
    <death_date>2009-02-01</death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>netherlands</reporter_country>
    <outcome outcome_code="de"/>
    <reaction reaction_preferred_term="agranulocytosis"/>
    <drug_datum>
      <drug_sequence>1011662564</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>cymbalta</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>unknown</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>021427</nda_number>
      <drug_indication indication_preferred_term="negative thoughts"/>
      <therapy>
        <start_date>2008-08-01</start_date>
        <end_date>2009-01-21</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011662565</drug_sequence>
      <role_code>c</role_code>
      <drug_name>clozapine</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route>unknown</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="psychotic disorder"/>
      <therapy>
        <start_date>2008-12-01</start_date>
        <end_date>2009-01-21</end_date>
        <duration>52.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011662566</drug_sequence>
      <role_code>c</role_code>
      <drug_name>cisordinol depot</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route>unknown</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="psychotic disorder"/>
      <therapy>
        <start_date></start_date>
        <end_date>2008-11-13</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>09Q3</yyqq>
    <isr>6280025</isr>
    <initial_followup_code>f</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6280025-4</image>
    <event_date></event_date>
    <manufacturer_date>2009-07-13</manufacturer_date>
    <fda_date>2009-07-23</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>nl-eli_lilly_and_company-nl200905004432</manufacturer_number>
    <manufacturer_sending>eli lilly and company</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>2009-07-17</report_date>
    <reporter_occupation>md</reporter_occupation>
    <death_date>2009-02-01</death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>netherlands</reporter_country>
    <outcome outcome_code="de"/>
    <reaction reaction_preferred_term="acute respiratory distress syndrome"/>
    <reaction reaction_preferred_term="agranulocytosis"/>
    <drug_datum>
      <drug_sequence>1011936003</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>cymbalta</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>unknown</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>021427</nda_number>
      <drug_indication indication_preferred_term="negative thoughts"/>
      <therapy>
        <start_date>2008-08-01</start_date>
        <end_date>2009-01-21</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011936004</drug_sequence>
      <role_code>c</role_code>
      <drug_name>clozapine</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>unknown</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="psychotic disorder"/>
      <therapy>
        <start_date>2008-11-28</start_date>
        <end_date>2009-01-21</end_date>
        <duration>55.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011936005</drug_sequence>
      <role_code>c</role_code>
      <drug_name>impromen /00568801/</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>
