<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="3292689">
  <adverse_event_report>
    <yyqq>99Q2</yyqq>
    <isr>3286444</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>3286444-2</image>
    <event_date>1999-05-26</event_date>
    <manufacturer_date>1999-06-10</manufacturer_date>
    <fda_date>1999-06-18</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>1999AP03123</manufacturer_number>
    <manufacturer_sending>Zeneca Pharmaceutical S</manufacturer_sending>
    <age>1.36071</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="Pulmonary Fibrosis"/>
    <reaction reaction_preferred_term="Superinfection"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="SDY"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1001089874</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Casodex</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1996-07-08</start_date>
        <end_date>1999-06-09</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1001101296</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Pulmicort</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>1001101297</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Foradil</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>1001101298</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Lindilane</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_report>
    <yyqq>99Q2</yyqq>
    <isr>3289089</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>1</followup_sequence>
    <image>3289089-3</image>
    <event_date>1999-05-26</event_date>
    <manufacturer_date>1999-06-10</manufacturer_date>
    <fda_date>1999-06-22</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>1999AP03123</manufacturer_number>
    <manufacturer_sending>Zeneca Pharmaceuticals</manufacturer_sending>
    <age>71.0</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="Breath Sounds Decreased"/>
    <reaction reaction_preferred_term="C-Reactive Protein Increased"/>
    <reaction reaction_preferred_term="Dyspnoea Exacerbated"/>
    <reaction reaction_preferred_term="Interstitial Lung Disease"/>
    <reaction reaction_preferred_term="Obstructive Chronic Bronchitis With Acute Exacerbation"/>
    <reaction reaction_preferred_term="Peak Expiratory Flow Rate Decreased"/>
    <reaction reaction_preferred_term="Pneumonitis Nos"/>
    <reaction reaction_preferred_term="Po2 Decreased"/>
    <reaction reaction_preferred_term="Pyrexia"/>
    <reaction reaction_preferred_term="Respiratory Distress"/>
    <reaction reaction_preferred_term="Sore Throat Nos"/>
    <reaction reaction_preferred_term="Sputum Abnormal Nos"/>
    <reaction reaction_preferred_term="White Blood Cell Count Decreased"/>
    <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>1001100011</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Casodex</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1996-07-08</start_date>
        <end_date>1999-06-09</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1001109349</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Pulmicort</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>1001109351</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Foradil</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>1001109353</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Lindilane</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>1001109354</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Glucocorticoid</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>1001109356</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Azithromycine</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_report>
    <yyqq>99Q2</yyqq>
    <isr>3293225</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>2</followup_sequence>
    <image>3293225-2</image>
    <event_date>1999-07-26</event_date>
    <manufacturer_date>1999-06-21</manufacturer_date>
    <fda_date>1999-06-28</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>1999AP03123</manufacturer_number>
    <manufacturer_sending>Zeneca Pharmaceuticals</manufacturer_sending>
    <age>71.0</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="Acute Exacerbation Of Chronic Bronchitis Nos"/>
    <reaction reaction_preferred_term="Blood Fibrinogen Increased"/>
    <reaction reaction_preferred_term="Breath Sounds Decreased"/>
    <reaction reaction_preferred_term="Bronchospasm Nos"/>
    <reaction reaction_preferred_term="C-Reactive Protein Increased"/>
    <reaction reaction_preferred_term="Dyspnoea Exacerbated"/>
    <reaction reaction_preferred_term="Erythrocyte Sedimentation Rate Abnormal"/>
    <reaction reaction_preferred_term="Interstitial Lung Disease"/>
    <reaction reaction_preferred_term="Peak Expiratory Flow Rate Decreased"/>
    <reaction reaction_preferred_term="Pneumonitis Nos"/>
    <reaction reaction_preferred_term="Po2 Decreased"/>
    <reaction reaction_preferred_term="Pyrexia"/>
    <reaction reaction_preferred_term="Sore Throat Nos"/>
    <reaction reaction_preferred_term="Sputum Abnormal Nos"/>
    <reaction reaction_preferred_term="Superinfection"/>
    <reaction reaction_preferred_term="White Blood Cell Count Increased"/>
    <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>1001114153</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Casodex</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1996-07-08</start_date>
        <end_date>1999-06-09</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1001126190</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Pulmicort</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>1001126192</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Foradil</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>1001126194</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Lindilane</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>1001126195</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Azithromycine</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_report>
    <yyqq>99Q3</yyqq>
    <isr>3361134</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>3</followup_sequence>
    <image>3361134-6</image>
    <event_date>1999-05-26</event_date>
    <manufacturer_date>1999-09-20</manufacturer_date>
    <fda_date>1999-09-29</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>1999AP03123</manufacturer_number>
    <manufacturer_sending>Zeneca Pharmaceuticals</manufacturer_sending>
    <age>71.0</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="Blood Carbon Dioxide Decreased"/>
    <reaction reaction_preferred_term="Breath Sounds Decreased"/>
    <reaction reaction_preferred_term="Bronchospasm Nos"/>
    <reaction reaction_preferred_term="C-Reactive Protein Increased"/>
    <reaction reaction_preferred_term="Dyspnoea Nos"/>
    <reaction reaction_preferred_term="Erythrocyte Sedimentation Rate Increased"/>
    <reaction reaction_preferred_term="Po2 Decreased"/>
    <reaction reaction_preferred_term="Pulmonary Fibrosis"/>
    <reaction reaction_preferred_term="Purulence Nos"/>
    <reaction reaction_preferred_term="Pyrexia"/>
    <reaction reaction_preferred_term="Respiratory Disorder Nos"/>
    <reaction reaction_preferred_term="Respiratory Rate Decreased"/>
    <reaction reaction_preferred_term="Sore Throat Nos"/>
    <reaction reaction_preferred_term="Sputum Abnormal Nos"/>
    <reaction reaction_preferred_term="Sputum Increased"/>
    <reaction reaction_preferred_term="Superinfection"/>
    <reaction reaction_preferred_term="White Blood Cell Count Increased"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="SDY"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1001336120</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Casodex</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>1996-07-08</start_date>
        <end_date>1999-06-10</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1001349833</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Pulmicort</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>1001349836</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Foradil</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>1001349839</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Lindilane</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>1001349842</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Glucocorticoid</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>1001349843</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Azithromycine</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>
