<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="3673777">
  <adverse_event_report>
    <yyqq>01Q2</yyqq>
    <isr>3745431</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>3745431-8</image>
    <event_date>2001-06-01</event_date>
    <manufacturer_date>2001-06-15</manufacturer_date>
    <fda_date>2001-06-22</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>EMADSS2001003763</manufacturer_number>
    <manufacturer_sending>Janssen Research Fdn Div Johnson And Johnson</manufacturer_sending>
    <age>12.0</age>
    <age_units>YR</age_units>
    <gender>F</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="OT"/>
    <reaction reaction_preferred_term="Adrenal Insufficiency Nos"/>
    <reaction reaction_preferred_term="Hypertrichosis"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1002608634</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Sporanox</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></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>2000-10-01</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1002628764</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Corticoides (Corticosteroid Nos)</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>1002628765</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>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>01Q3</yyqq>
    <isr>3758521</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>1</followup_sequence>
    <image>3758521-0</image>
    <event_date>2001-06-01</event_date>
    <manufacturer_date>2001-06-28</manufacturer_date>
    <fda_date>2001-07-13</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>EMADSS2001003763</manufacturer_number>
    <manufacturer_sending>Janssen Research Fdn Div Johnson And Johnson</manufacturer_sending>
    <age>12.0</age>
    <age_units>YR</age_units>
    <gender>F</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="OT"/>
    <reaction reaction_preferred_term="Adrenal Insufficiency Nos"/>
    <reaction reaction_preferred_term="Cushing'S Syndrome"/>
    <reaction reaction_preferred_term="Hypertrichosis"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1002657048</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Sporanox</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></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>2000-10-01</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1002669710</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Corticoides (Corticosteroid Nos)</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>1002669713</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>1002669715</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Cellcept</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>1002669716</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Prograf</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>1002669718</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Solumag (Magnesium Pidolate)</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>1002669719</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Ursolvan (Ursodeoxycholic Acid)</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>1002669720</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>1002669722</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Flixotide (Fluticasone Propionate)</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>01Q3</yyqq>
    <isr>3766493</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>2</followup_sequence>
    <image>3766493-8</image>
    <event_date>2001-06-01</event_date>
    <manufacturer_date>2001-07-12</manufacturer_date>
    <fda_date>2001-07-26</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>EMADSS2001003763</manufacturer_number>
    <manufacturer_sending>Janssen Research Fdn Div Johnson And Johnson</manufacturer_sending>
    <age>12.0</age>
    <age_units>YR</age_units>
    <gender>F</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="OT"/>
    <reaction reaction_preferred_term="Adrenal Insufficiency Nos"/>
    <reaction reaction_preferred_term="Cushing'S Syndrome"/>
    <reaction reaction_preferred_term="Hypertrichosis"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1002686742</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Sporanox</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></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>2000-10-01</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1002692069</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Corticoides (Corti-Costeroid Nos)</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>1002692070</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>1002692071</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Cellcept</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>1002692072</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Prograf</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>1002692074</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Solumag (Magnesium Pidolate)</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>1002692075</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Ursolvan (Ursodeoxycholic Acid)</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>1002692077</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>1002692078</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Flixotide (Fluticasone Propionate)</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>
