<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="3186572">
  <adverse_event_report>
    <yyqq>99Q1</yyqq>
    <isr>3177452</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>3177452-0</image>
    <event_date>1998-11-30</event_date>
    <manufacturer_date>1998-12-15</manufacturer_date>
    <fda_date>1999-01-04</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>1998AP50790</manufacturer_number>
    <manufacturer_sending>Zeneca Pharmaceuticals A Business Unit Of Zeneca Inc</manufacturer_sending>
    <age>61.0</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="HO"/>
    <reaction reaction_preferred_term="Bundle Branch Block Left"/>
    <reaction reaction_preferred_term="Cardiac Failure Nos"/>
    <reaction reaction_preferred_term="Cardiac Murmur Nos"/>
    <reaction reaction_preferred_term="Congestive (Dilated) Cardiomyopathy"/>
    <reaction reaction_preferred_term="Dyspnoea Exertional"/>
    <reaction reaction_preferred_term="Ejection Fraction Abnormal"/>
    <reaction reaction_preferred_term="Gallop Rhythm Present"/>
    <reaction reaction_preferred_term="Low Cardiac Output Syndrome"/>
    <reaction reaction_preferred_term="Necrosis"/>
    <reaction reaction_preferred_term="Oedema Lower Limb"/>
    <reaction reaction_preferred_term="Pulmonary Hypertension Nos"/>
    <reaction reaction_preferred_term="Rales"/>
    <reaction reaction_preferred_term="Sinus Tachycardia"/>
    <reaction reaction_preferred_term="Venous Pressure Jugular Increased"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="SDY"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1000733940</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Seroquel</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>N</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1998-10-17</start_date>
        <end_date>1998-10-19</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
      <therapy>
        <start_date>1998-10-20</start_date>
        <end_date>1998-12-15</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000738065</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Lactulose</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_report>
    <yyqq>99Q1</yyqq>
    <isr>3208492</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>1</followup_sequence>
    <image>3208492-0</image>
    <event_date>1998-11-30</event_date>
    <manufacturer_date>1999-02-19</manufacturer_date>
    <fda_date>1999-02-26</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>1998AP50790</manufacturer_number>
    <manufacturer_sending>Zeneca Pharmaceuticals</manufacturer_sending>
    <age>61.0</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="HO"/>
    <reaction reaction_preferred_term="Bundle Branch Block Left"/>
    <reaction reaction_preferred_term="Cardiac Failure Nos"/>
    <reaction reaction_preferred_term="Cardiac Murmur Nos"/>
    <reaction reaction_preferred_term="Congestive (Dilated) Cardiomyopathy"/>
    <reaction reaction_preferred_term="Drug Toxicity Nos"/>
    <reaction reaction_preferred_term="Dyspnoea Exertional"/>
    <reaction reaction_preferred_term="Ejection Fraction Abnormal"/>
    <reaction reaction_preferred_term="Gallop Rhythm Present"/>
    <reaction reaction_preferred_term="Necrosis"/>
    <reaction reaction_preferred_term="Oedema Lower Limb"/>
    <reaction reaction_preferred_term="Oedema Nos"/>
    <reaction reaction_preferred_term="Pulmonary Hypertension Nos"/>
    <reaction reaction_preferred_term="Rales"/>
    <reaction reaction_preferred_term="Sinus Tachycardia"/>
    <reaction reaction_preferred_term="Sinusitis Nos"/>
    <reaction reaction_preferred_term="Vein Disorder 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>1000836117</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Seroquel</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>N</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1998-10-17</start_date>
        <end_date>1998-10-19</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
      <therapy>
        <start_date>1998-10-20</start_date>
        <end_date>1998-12-15</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000844503</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Lactulose</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_report>
    <yyqq>99Q1</yyqq>
    <isr>3222573</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>2</followup_sequence>
    <image>3222573-7</image>
    <event_date>1998-11-30</event_date>
    <manufacturer_date>1999-03-11</manufacturer_date>
    <fda_date>1999-03-17</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>1998AP50790</manufacturer_number>
    <manufacturer_sending>Zeneca Pharmaceuticals A Business Unit Of Zeneca Inc</manufacturer_sending>
    <age>61.0</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="HO"/>
    <outcome outcome_code="RI"/>
    <reaction reaction_preferred_term="Bundle Branch Block Left"/>
    <reaction reaction_preferred_term="C-Reactive Protein Increased"/>
    <reaction reaction_preferred_term="Cardiac Failure Nos"/>
    <reaction reaction_preferred_term="Cardiac Murmur Nos"/>
    <reaction reaction_preferred_term="Cardiac Output Decreased"/>
    <reaction reaction_preferred_term="Congestive (Dilated) Cardiomyopathy"/>
    <reaction reaction_preferred_term="Drug Toxicity Nos"/>
    <reaction reaction_preferred_term="Dyspnoea Exertional"/>
    <reaction reaction_preferred_term="Ejection Fraction Abnormal"/>
    <reaction reaction_preferred_term="Gallop Rhythm Present"/>
    <reaction reaction_preferred_term="Gamma-Glutamyltransferase Increased"/>
    <reaction reaction_preferred_term="Heart Rate Increased"/>
    <reaction reaction_preferred_term="Oedema Lower Limb"/>
    <reaction reaction_preferred_term="Pulmonary Hypertension Nos"/>
    <reaction reaction_preferred_term="Rales"/>
    <reaction reaction_preferred_term="Sinus Tachycardia"/>
    <reaction reaction_preferred_term="Sinusitis Nos"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="SDY"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1000878952</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Seroquel</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>N</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1998-10-17</start_date>
        <end_date>1998-10-19</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000882681</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Seroquel</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>N</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1998-10-20</start_date>
        <end_date>1998-12-15</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000882683</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Lactulose</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_report>
    <yyqq>99Q3</yyqq>
    <isr>3300441</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>3</followup_sequence>
    <image>3300441-X</image>
    <event_date>1998-11-30</event_date>
    <manufacturer_date>1999-06-28</manufacturer_date>
    <fda_date>1999-07-09</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>1998AP50790</manufacturer_number>
    <manufacturer_sending>Zeneca Pharmaceuticals</manufacturer_sending>
    <age>61.0</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="HO"/>
    <outcome outcome_code="RI"/>
    <reaction reaction_preferred_term="Bundle Branch Block Left"/>
    <reaction reaction_preferred_term="C-Reactive Protein Increased"/>
    <reaction reaction_preferred_term="Cardiac Failure Nos"/>
    <reaction reaction_preferred_term="Cardiac Murmur Nos"/>
    <reaction reaction_preferred_term="Cardiomyopathy Nos"/>
    <reaction reaction_preferred_term="Congestive (Dilated) Cardiomyopathy"/>
    <reaction reaction_preferred_term="Dyspnoea Exertional"/>
    <reaction reaction_preferred_term="Ejection Fraction Abnormal"/>
    <reaction reaction_preferred_term="Gallop Rhythm Present"/>
    <reaction reaction_preferred_term="Gamma-Glutamyltransferase Increased"/>
    <reaction reaction_preferred_term="Hyponatraemia"/>
    <reaction reaction_preferred_term="Low Cardiac Output Syndrome"/>
    <reaction reaction_preferred_term="Oedema Lower Limb"/>
    <reaction reaction_preferred_term="Pulmonary Hypertension Nos"/>
    <reaction reaction_preferred_term="Rales"/>
    <reaction reaction_preferred_term="Venous Pressure Jugular Increased"/>
    <reaction reaction_preferred_term="Weight Decreased"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="SDY"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1001136032</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Seroquel</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>Y</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1998-10-17</start_date>
        <end_date>1998-10-19</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1001142681</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Seroquel</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>Y</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1998-10-20</start_date>
        <end_date>1998-12-15</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1001142682</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Lactulose</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_report>
    <yyqq>99Q4</yyqq>
    <isr>3408953</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>4</followup_sequence>
    <image>3408953-5</image>
    <event_date>1999-11-02</event_date>
    <manufacturer_date>1999-11-15</manufacturer_date>
    <fda_date>1999-11-24</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>1998AP50790</manufacturer_number>
    <manufacturer_sending>Zeneca Pharmaceuticals</manufacturer_sending>
    <age>61.0</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"/>
    <outcome outcome_code="LT"/>
    <outcome outcome_code="HO"/>
    <outcome outcome_code="RI"/>
    <reaction reaction_preferred_term="Arterial Aneurysm Nos"/>
    <reaction reaction_preferred_term="Bundle Branch Block Left"/>
    <reaction reaction_preferred_term="C-Reactive Protein Increased"/>
    <reaction reaction_preferred_term="Cardiac Failure Nos"/>
    <reaction reaction_preferred_term="Cardiac Murmur Nos"/>
    <reaction reaction_preferred_term="Cardio-Respiratory Arrest"/>
    <reaction reaction_preferred_term="Congestive (Dilated) Cardiomyopathy"/>
    <reaction reaction_preferred_term="Dyspnoea Exertional"/>
    <reaction reaction_preferred_term="Dyspnoea Nos"/>
    <reaction reaction_preferred_term="Ejection Fraction Abnormal"/>
    <reaction reaction_preferred_term="Gallop Rhythm Present"/>
    <reaction reaction_preferred_term="Gamma-Glutamyltransferase Increased"/>
    <reaction reaction_preferred_term="Hyponatraemia"/>
    <reaction reaction_preferred_term="Myocardial Infarction"/>
    <reaction reaction_preferred_term="Necrosis"/>
    <reaction reaction_preferred_term="Oedema Lower Limb"/>
    <reaction reaction_preferred_term="Pulmonary Hypertension Nos"/>
    <reaction reaction_preferred_term="Rales"/>
    <reaction reaction_preferred_term="Sinus Tachycardia"/>
    <reaction reaction_preferred_term="Sinusitis Nos"/>
    <reaction reaction_preferred_term="Venous Pressure Jugular Increased"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="SDY"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1001468895</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Seroquel</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>Y</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1998-10-17</start_date>
        <end_date>1998-10-19</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1001482377</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Seroquel</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>Y</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1998-10-21</start_date>
        <end_date>1998-12-15</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1001482378</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Lactulose</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>1001482379</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Lasilix</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>1001482380</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Zestril</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>1001482381</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Digoxin</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>1001482382</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Solian</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>1001482383</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Seresta</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>
