<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="7117657">
  <adverse_event_report>
    <yyqq>09Q3</yyqq>
    <isr>6360117</isr>
    <initial_followup_code>i</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6360117-1</image>
    <event_date>2002-10-24</event_date>
    <manufacturer_date>2009-09-14</manufacturer_date>
    <fda_date>2009-09-17</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>phhy2009gb39241</manufacturer_number>
    <manufacturer_sending>novartis pharmaceutical corporation</manufacturer_sending>
    <age>44.0</age>
    <age_units>YR</age_units>
    <gender>f</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2009-09-17</report_date>
    <reporter_occupation>ot</reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united kingdom</reporter_country>
    <outcome outcome_code="de"/>
    <outcome outcome_code="ot"/>
    <reaction reaction_preferred_term="death"/>
    <reaction reaction_preferred_term="deep vein thrombosis"/>
    <reaction reaction_preferred_term="pulmonary embolism"/>
    <drug_datum>
      <drug_sequence>1012263438</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>clozapine</drug_name>
      <validated_or_verbatim>2</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>19758</nda_number>
      <drug_indication indication_preferred_term="psychotic disorder"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012263439</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>clomipramine</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_indication indication_preferred_term="depression"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012263440</drug_sequence>
      <role_code>c</role_code>
      <drug_name>lorazepam</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_indication indication_preferred_term="anxiety"/>
    </drug_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>09Q3</yyqq>
    <isr>6375373</isr>
    <initial_followup_code>f</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6375373-3</image>
    <event_date>2002-10-24</event_date>
    <manufacturer_date>2009-09-18</manufacturer_date>
    <fda_date>2009-09-24</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>phhy2009gb39241</manufacturer_number>
    <manufacturer_sending>novartis pharmaceutical corporation</manufacturer_sending>
    <age>44.0</age>
    <age_units>YR</age_units>
    <gender>f</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2009-09-24</report_date>
    <reporter_occupation>ot</reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united kingdom</reporter_country>
    <outcome outcome_code="de"/>
    <outcome outcome_code="ot"/>
    <reaction reaction_preferred_term="death"/>
    <reaction reaction_preferred_term="deep vein thrombosis"/>
    <reaction reaction_preferred_term="pulmonary embolism"/>
    <drug_datum>
      <drug_sequence>1012327100</drug_sequence>
      <role_code>ps</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>19758</nda_number>
      <drug_indication indication_preferred_term="psychotic disorder"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012327101</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>clomipramine</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_indication indication_preferred_term="depression"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012327102</drug_sequence>
      <role_code>c</role_code>
      <drug_name>lorazepam</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_indication indication_preferred_term="anxiety"/>
    </drug_datum>
  </adverse_event_report>
</adverse_event_case>
