<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="7134392">
  <adverse_event_report>
    <yyqq>09Q3</yyqq>
    <isr>6381350</isr>
    <initial_followup_code>i</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6381350-9</image>
    <event_date>2009-09-18</event_date>
    <manufacturer_date>2009-09-22</manufacturer_date>
    <fda_date>2009-09-29</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-genentech-290900</manufacturer_number>
    <manufacturer_sending>gnefdaaersprd</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>m</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight>78.912</weight>
    <weight_units>KG</weight_units>
    <report_date>2009-09-29</report_date>
    <reporter_occupation>md</reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="ho"/>
    <reaction reaction_preferred_term="neutropenia"/>
    <reaction reaction_preferred_term="pyrexia"/>
    <drug_datum>
      <drug_sequence>1012349850</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>bevacizumab</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route>intravesical</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number>762145</lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="non-small cell lung cancer"/>
      <therapy>
        <start_date>2009-09-11</start_date>
        <end_date>2009-09-11</end_date>
        <duration>1.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012349851</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>alimta</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>intravenous</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number>a561439c</lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="non-small cell lung cancer"/>
      <therapy>
        <start_date>2009-09-11</start_date>
        <end_date>2009-09-11</end_date>
        <duration>1.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012349852</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>gemcitabine</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>intravenous</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number>a51227a</lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="non-small cell lung cancer"/>
      <therapy>
        <start_date>2009-09-11</start_date>
        <end_date>2009-09-11</end_date>
        <duration>1.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012349853</drug_sequence>
      <role_code>c</role_code>
      <drug_name>feratab</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012349854</drug_sequence>
      <role_code>c</role_code>
      <drug_name>k-tab</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012349855</drug_sequence>
      <role_code>c</role_code>
      <drug_name>glucophage</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012349856</drug_sequence>
      <role_code>c</role_code>
      <drug_name>lipitor</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012349857</drug_sequence>
      <role_code>c</role_code>
      <drug_name>dyrenium</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012349858</drug_sequence>
      <role_code>c</role_code>
      <drug_name>folic acid</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012349859</drug_sequence>
      <role_code>c</role_code>
      <drug_name>promethazine</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012349860</drug_sequence>
      <role_code>c</role_code>
      <drug_name>oxycodone hcl and acetaminophen</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012349861</drug_sequence>
      <role_code>c</role_code>
      <drug_name>ampicillin</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012349862</drug_sequence>
      <role_code>c</role_code>
      <drug_name>clarithromycin</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="helicobacter infection"/>
      <therapy>
        <start_date>2009-08-29</start_date>
        <end_date>2009-09-13</end_date>
        <duration>16.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012349863</drug_sequence>
      <role_code>c</role_code>
      <drug_name>lactobacillus acidophilus</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></nda_number>
      <drug_indication indication_preferred_term="helicobacter infection"/>
      <therapy>
        <start_date>2009-08-29</start_date>
        <end_date>2009-09-13</end_date>
        <duration>16.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012349864</drug_sequence>
      <role_code>c</role_code>
      <drug_name>b12 complex</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="drug use for unknown indication"/>
      <therapy>
        <start_date>2009-08-28</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>09Q4</yyqq>
    <isr>6387205</isr>
    <initial_followup_code>f</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6387205-8</image>
    <event_date>2009-09-18</event_date>
    <manufacturer_date>2009-09-28</manufacturer_date>
    <fda_date>2009-10-02</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-genentech-290900</manufacturer_number>
    <manufacturer_sending>gnefdaaersprd</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>m</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight>78.912</weight>
    <weight_units>KG</weight_units>
    <report_date>2009-10-02</report_date>
    <reporter_occupation>md</reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="ho"/>
    <reaction reaction_preferred_term="neutropenia"/>
    <reaction reaction_preferred_term="pyrexia"/>
    <drug_datum>
      <drug_sequence>1012373146</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>bevacizumab</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route>intravesical</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number>762145</lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="non-small cell lung cancer"/>
      <therapy>
        <start_date>2009-09-11</start_date>
        <end_date>2009-09-11</end_date>
        <duration>1.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012373147</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>alimta</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>intravenous</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number>a561439c</lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="non-small cell lung cancer"/>
      <therapy>
        <start_date>2009-09-11</start_date>
        <end_date>2009-09-11</end_date>
        <duration>1.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012373148</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>gemcitabine</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>intravenous</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number>a51227a</lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="non-small cell lung cancer"/>
      <therapy>
        <start_date>2009-09-11</start_date>
        <end_date>2009-09-11</end_date>
        <duration>1.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012373149</drug_sequence>
      <role_code>c</role_code>
      <drug_name>feratab</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012373150</drug_sequence>
      <role_code>c</role_code>
      <drug_name>k-tab</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012373151</drug_sequence>
      <role_code>c</role_code>
      <drug_name>glucophage</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012373152</drug_sequence>
      <role_code>c</role_code>
      <drug_name>lipitor</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012373153</drug_sequence>
      <role_code>c</role_code>
      <drug_name>dyrenium</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012373154</drug_sequence>
      <role_code>c</role_code>
      <drug_name>folic acid</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012373155</drug_sequence>
      <role_code>c</role_code>
      <drug_name>promethazine</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012373156</drug_sequence>
      <role_code>c</role_code>
      <drug_name>oxycodone hcl and acetaminophen</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012373157</drug_sequence>
      <role_code>c</role_code>
      <drug_name>ampicillin</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012373158</drug_sequence>
      <role_code>c</role_code>
      <drug_name>clarithromycin</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="helicobacter infection"/>
      <therapy>
        <start_date>2009-08-29</start_date>
        <end_date>2009-09-13</end_date>
        <duration>16.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012373159</drug_sequence>
      <role_code>c</role_code>
      <drug_name>lactobacillus acidophilus</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></nda_number>
      <drug_indication indication_preferred_term="helicobacter infection"/>
      <therapy>
        <start_date>2009-08-29</start_date>
        <end_date>2009-09-13</end_date>
        <duration>16.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012373160</drug_sequence>
      <role_code>c</role_code>
      <drug_name>b12 complex</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="drug use for unknown indication"/>
      <therapy>
        <start_date>2009-08-28</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>09Q4</yyqq>
    <isr>6391919</isr>
    <initial_followup_code>f</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6391919-3</image>
    <event_date>2009-09-18</event_date>
    <manufacturer_date>2009-10-06</manufacturer_date>
    <fda_date>2009-10-07</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-genentech-290900</manufacturer_number>
    <manufacturer_sending>gnefdaaersprd</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>m</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight>78.912</weight>
    <weight_units>KG</weight_units>
    <report_date>2009-10-07</report_date>
    <reporter_occupation>md</reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="ho"/>
    <reaction reaction_preferred_term="neutropenia"/>
    <reaction reaction_preferred_term="pyrexia"/>
    <drug_datum>
      <drug_sequence>1012390384</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>bevacizumab</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route>intravesical</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number>762145</lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="non-small cell lung cancer"/>
      <therapy>
        <start_date>2009-09-11</start_date>
        <end_date>2009-09-11</end_date>
        <duration>1.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012390385</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>alimta</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>intravenous</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number>a561439c</lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="non-small cell lung cancer"/>
      <therapy>
        <start_date>2009-09-11</start_date>
        <end_date>2009-09-11</end_date>
        <duration>1.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012390386</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>gemcitabine</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>intravenous</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number>a51227a</lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="non-small cell lung cancer"/>
      <therapy>
        <start_date>2009-09-11</start_date>
        <end_date>2009-09-11</end_date>
        <duration>1.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012390387</drug_sequence>
      <role_code>c</role_code>
      <drug_name>feratab</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012390388</drug_sequence>
      <role_code>c</role_code>
      <drug_name>k-tab</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012390389</drug_sequence>
      <role_code>c</role_code>
      <drug_name>glucophage</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012390390</drug_sequence>
      <role_code>c</role_code>
      <drug_name>lipitor</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012390391</drug_sequence>
      <role_code>c</role_code>
      <drug_name>dyrenium</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012390392</drug_sequence>
      <role_code>c</role_code>
      <drug_name>folic acid</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012390393</drug_sequence>
      <role_code>c</role_code>
      <drug_name>promethazine</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012390394</drug_sequence>
      <role_code>c</role_code>
      <drug_name>oxycodone hcl and acetaminophen</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012390395</drug_sequence>
      <role_code>c</role_code>
      <drug_name>ampicillin</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></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012390396</drug_sequence>
      <role_code>c</role_code>
      <drug_name>clarithromycin</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="helicobacter infection"/>
      <therapy>
        <start_date>2009-08-29</start_date>
        <end_date>2009-09-13</end_date>
        <duration>16.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012390397</drug_sequence>
      <role_code>c</role_code>
      <drug_name>lactobacillus acidophilus</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></nda_number>
      <drug_indication indication_preferred_term="helicobacter infection"/>
      <therapy>
        <start_date>2009-08-29</start_date>
        <end_date>2009-09-13</end_date>
        <duration>16.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012390398</drug_sequence>
      <role_code>c</role_code>
      <drug_name>b12 complex</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="drug use for unknown indication"/>
      <therapy>
        <start_date>2009-08-28</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
  </adverse_event_report>
</adverse_event_case>
