<ichicsr lang="en">
 <ichicsrmessageheader>
  <messagetype>ICSR</messagetype>
  <messageformatversion>2.1</messageformatversion>
  <messageformatrelease>1.0</messageformatrelease>
  <messagenumb>2002-07</messagenumb>
  <messagesenderidentifier>FDA CDER ODS</messagesenderidentifier>
  <messagereceiveridentifier>Public Use</messagereceiveridentifier>
  <messagedateformat>204</messagedateformat>
  <messagedate>2003042901:27:39</messagedate>
 </ichicsrmessageheader>
  <safetyreport>
   <safetyreportid>3895794-8</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20030429</transmissiondate>
   <serious>1</serious>
   <seriousnessother>1</seriousnessother>
   <receivedateformat>102</receivedateformat>
   <receivedate>20020404</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20020326</receiptdate>
   <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
   <companynumb>PHNU2002DE01185</companynumb>
  <primarysource>
     <qualification>1</qualification>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientonsetage>55</patientonsetage>
     <patientonsetageunit>801</patientonsetageunit>
     <patientweight>108</patientweight>
     <patientsex>1</patientsex>
  <reaction>
     <reactionmeddrapt>ENTHESOPATHY</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>DIOVAN HCT</medicinalproduct>
     <drugauthorizationnumb>20818</drugauthorizationnumb>
     <drugdosagetext>1 DF, BID, ORAL</drugdosagetext>
     <drugadministrationroute>048</drugadministrationroute>
     <drugindication>HYPERTENSION NOS</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20010801</drugstartdate>
     <drugenddateformat>102</drugenddateformat>
     <drugenddate>20020101</drugenddate>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>NORVASC</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>TROMCARDIN FORTE (ASPARTATE POTASSIUM, MAGNESIUM ASPARTATE)</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>CATAPRESAN (CLONIDINE)</medicinalproduct>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>3897534-5</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20030429</transmissiondate>
   <receivedateformat>102</receivedateformat>
   <receivedate>20020401</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20020319</receiptdate>
   <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
   <companynumb>309612</companynumb>
  <primarysource>
     <qualification>1</qualification>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientsex>2</patientsex>
  <reaction>
     <reactionmeddrapt>ANAEMIA NOS</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>HYPERVOLAEMIA</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>DACLIZUMAB (DACLIZUMAB)</medicinalproduct>
     <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
  </drug>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)</medicinalproduct>
     <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
  </drug>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>ATGAM</medicinalproduct>
     <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
  </drug>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>SIROLIMUS (SIROLIMUS)</medicinalproduct>
     <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
  </drug>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>ETANERCEPT (ETANERCEPT)</medicinalproduct>
     <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>GANCICLOVIR SODIUM</medicinalproduct>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>3897554-0</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20030429</transmissiondate>
   <serious>1</serious>
   <seriousnesshospitalization>1</seriousnesshospitalization>
   <receivedateformat>102</receivedateformat>
   <receivedate>20020409</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20020402</receiptdate>
   <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
   <companynumb>WAES 0203USA03228</companynumb>
  <primarysource>
     <qualification>1</qualification>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientonsetage>63</patientonsetage>
     <patientonsetageunit>801</patientonsetageunit>
     <patientweight>77.1115</patientweight>
     <patientsex>2</patientsex>
  <reaction>
     <reactionmeddrapt>COUGH</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>MALAISE</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>WHEEZING</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>FOSAMAX</medicinalproduct>
     <drugauthorizationnumb>20560</drugauthorizationnumb>
     <drugdosagetext>35 MG/WKY/PO</drugdosagetext>
     <drugadministrationroute>048</drugadministrationroute>
     <drugindication>OSTEOPENIA</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20010719</drugstartdate>
     <drugenddateformat>102</drugenddateformat>
     <drugenddate>20020120</drugenddate>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>ESTRACE</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>LIPITOR</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>MAXZIDE</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>CALCIUM</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>POTASSIUM</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>VITAMINS</medicinalproduct>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>3898289-0</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20030429</transmissiondate>
   <serious>1</serious>
   <seriousnesslifethreatening>1</seriousnesslifethreatening>
   <seriousnessdisabling>1</seriousnessdisabling>
   <receivedateformat>102</receivedateformat>
   <receivedate>20020410</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20020403</receiptdate>
   <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
   <companynumb>FR8947603APR2002</companynumb>
  <primarysource>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientonsetage>69</patientonsetage>
     <patientonsetageunit>801</patientonsetageunit>
     <patientsex>2</patientsex>
  <reaction>
     <reactionmeddrapt>COMA</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>CONFUSION</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>HALLUCINATION NOS</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>LORAZEPAM</medicinalproduct>
     <drugauthorizationnumb>17794</drugauthorizationnumb>
     <drugdosagetext>ORAL</drugdosagetext>
     <drugadministrationroute>048</drugadministrationroute>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>ASTROCYTOMA</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>LIORESAL</medicinalproduct>
     <drugdosagetext>1 DOSE 50 TIMES PER DAY</drugdosagetext>
     <drugadministrationroute>042</drugadministrationroute>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>19930101</drugstartdate>
  </drug>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>CLONAZEPAM</medicinalproduct>
     <drugdosagetext>5 DOSES DAILY</drugdosagetext>
     <drugadministrationroute>048</drugadministrationroute>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>3898842-4</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20030429</transmissiondate>
   <receivedateformat>102</receivedateformat>
   <receivedate>20020409</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20020409</receiptdate>
   <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
  <primarysource>
     <qualification>1</qualification>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
  <reaction>
     <reactionmeddrapt>CONVULSIONS NOS AGGRAVATED</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
     <drugdosagetext>200MG PO X 5/D; 2 YEARS AGO</drugdosagetext>
     <drugadministrationroute>048</drugadministrationroute>
     <drugindication>CONVULSIONS NOS</drugindication>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>3899493-8</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20030429</transmissiondate>
   <serious>1</serious>
   <seriousnessother>1</seriousnessother>
   <receivedateformat>102</receivedateformat>
   <receivedate>20020411</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20020318</receiptdate>
   <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
   <companynumb>2002-BP-01343AU (0)</companynumb>
  <primarysource>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientonsetage>58</patientonsetage>
     <patientonsetageunit>801</patientonsetageunit>
     <patientsex>2</patientsex>
  <reaction>
     <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>MICARDIS</medicinalproduct>
     <drugauthorizationnumb>20850</drugauthorizationnumb>
     <drugdosagetext>160 MG (40 MG, 1 TABLET QID)</drugdosagetext>
     <drugadministrationroute>048</drugadministrationroute>
     <drugindication>ESSENTIAL HYPERTENSION</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20010512</drugstartdate>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>3900179-1</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20030429</transmissiondate>
   <serious>1</serious>
   <seriousnessother>1</seriousnessother>
   <receivedateformat>102</receivedateformat>
   <receivedate>20020412</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20020408</receiptdate>
   <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
   <companynumb>2002100861GB</companynumb>
  <primarysource>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientonsetage>36</patientonsetage>
     <patientonsetageunit>801</patientonsetageunit>
     <patientsex>2</patientsex>
  <reaction>
     <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>TREMOR</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>DEPO-PROVERA</medicinalproduct>
     <drugauthorizationnumb>20246</drugauthorizationnumb>
     <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
     <drugadministrationroute>030</drugadministrationroute>
     <drugindication>CONTRACEPTION NOS</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>30030305</drugstartdate>
     <drugenddateformat>102</drugenddateformat>
     <drugenddate>30030305</drugenddate>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>3906320-9</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20030429</transmissiondate>
   <serious>1</serious>
   <seriousnesslifethreatening>1</seriousnesslifethreatening>
   <receivedateformat>102</receivedateformat>
   <receivedate>20020424</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20020424</receiptdate>
   <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
  <primarysource>
     <qualification>1</qualification>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientonsetage>63</patientonsetage>
     <patientonsetageunit>801</patientonsetageunit>
     <patientweight>86.1834</patientweight>
     <patientsex>1</patientsex>
  <reaction>
     <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>DIARRHOEA NOS</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>FATIGUE</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>NAUSEA</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>TARCEVA (GENENTECH) 150 MG</medicinalproduct>
     <drugdosagetext>QD X 21 DAYS</drugdosagetext>
     <drugindication>NON SMALL CELL LUNG CANCER NOS</drugindication>
  </drug>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>TAXOL</medicinalproduct>
     <drugdosagetext>QD 3 WEEKS</drugdosagetext>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>3907010-9</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20030429</transmissiondate>
   <serious>1</serious>
   <seriousnessother>1</seriousnessother>
   <receivedateformat>102</receivedateformat>
   <receivedate>20020425</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20020425</receiptdate>
   <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
  <primarysource>
     <qualification>2</qualification>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientweight>77.1115</patientweight>
     <patientsex>1</patientsex>
  <reaction>
     <reactionmeddrapt>OEDEMA NOS</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>PRURITUS NOS</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>RASH NOS</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>URTICARIA NOS</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>REMBRANDT TOOTH BLEACHING</medicinalproduct>
     <drugdosagetext>1 TRAY - ONCE DAILY DENTAL</drugdosagetext>
     <drugadministrationroute>004</drugadministrationroute>
     <drugindication>DENTAL TREATMENT NOS</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20020415</drugstartdate>
     <drugenddateformat>102</drugenddateformat>
     <drugenddate>20020417</drugenddate>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>IBUPROFEN</medicinalproduct>
  </drug>
  </patient>
  </safetyreport>
<safetyreport>
   <safetyreportid>4005724-6</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20030429</transmissiondate>
   <receivedateformat>102</receivedateformat>
   <receivedate>20020617</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20020302</receiptdate>
   <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
   <companynumb>US010181</companynumb>
  <primarysource>
     <qualification>3</qualification>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientonsetage>37</patientonsetage>
     <patientonsetageunit>801</patientonsetageunit>
     <patientsex>2</patientsex>
  <reaction>
     <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>DYSPNOEA NOS</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>HEADACHE NOS</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>INJECTION SITE REACTION NOS</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>PRURITUS NOS</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>TONGUE DISORDER NOS</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>URTICARIA NOS</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>KINERET</medicinalproduct>
     <drugdosagetext>100 MG, DAILY, SC</drugdosagetext>
     <drugadministrationroute>058</drugadministrationroute>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20020228</drugstartdate>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>DEXAMETHASONE</medicinalproduct>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>4005726-X</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20030429</transmissiondate>
   <receivedateformat>102</receivedateformat>
   <receivedate>20020617</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20020304</receiptdate>
   <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
   <companynumb>US010202</companynumb>
  <primarysource>
     <qualification>2</qualification>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientsex>2</patientsex>
  <reaction>
     <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>KINERET</medicinalproduct>
     <drugindication>RHEUMATOID ARTHRITIS</drugindication>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>4005727-1</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20030429</transmissiondate>
   <receivedateformat>102</receivedateformat>
   <receivedate>20020617</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20020304</receiptdate>
   <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
   <companynumb>US010207</companynumb>
  <primarysource>
     <qualification>1</qualification>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientsex>1</patientsex>
  <reaction>
     <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>VASCULAR DISORDER NOS</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>KINERET</medicinalproduct>
     <drugindication>RHEUMATOID ARTHRITIS</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20020131</drugstartdate>
     <drugenddateformat>102</drugenddateformat>
     <drugenddate>20020228</drugenddate>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>4005729-5</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20030429</transmissiondate>
   <receivedateformat>102</receivedateformat>
   <receivedate>20020617</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20020226</receiptdate>
   <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
   <companynumb>US010231</companynumb>
  <primarysource>
     <qualification>1</qualification>
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  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientsex>2</patientsex>
  <reaction>
     <reactionmeddrapt>INJECTION SITE REACTION NOS</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>KINERET</medicinalproduct>
     <drugdosagetext>100 MG, DAILY, SC</drugdosagetext>
     <drugadministrationroute>058</drugadministrationroute>
     <drugindication>RHEUMATOID ARTHRITIS</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20020201</drugstartdate>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>4005730-1</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20030429</transmissiondate>
   <receivedateformat>102</receivedateformat>
   <receivedate>20020617</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20020304</receiptdate>
   <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
   <companynumb>US010239</companynumb>
  <primarysource>
     <qualification>5</qualification>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientonsetage>47</patientonsetage>
     <patientonsetageunit>801</patientonsetageunit>
     <patientweight>79.5</patientweight>
     <patientsex>2</patientsex>
  <reaction>
     <reactionmeddrapt>INJECTION SITE REACTION NOS</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>KINERET</medicinalproduct>
     <drugdosagetext>100 MG, DAILY, SC</drugdosagetext>
     <drugadministrationroute>058</drugadministrationroute>
     <drugindication>RHEUMATOID ARTHRITIS</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20020215</drugstartdate>
     <drugenddateformat>102</drugenddateformat>
     <drugenddate>20020227</drugenddate>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>IBUPROFEN</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>PREDNISONE</medicinalproduct>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>4006462-6</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20030429</transmissiondate>
   <serious>1</serious>
   <seriousnesshospitalization>1</seriousnesshospitalization>
   <receivedateformat>102</receivedateformat>
   <receivedate>20020726</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20020623</receiptdate>
   <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
   <companynumb>B0271459A</companynumb>
  <primarysource>
     <qualification>1</qualification>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientsex>2</patientsex>
  <reaction>
     <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>PLASMODIUM FALCIPARUM INFECTION</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>MALARONE</medicinalproduct>
     <drugauthorizationnumb>21078</drugauthorizationnumb>
     <drugindication>PROPHYLAXIS NOS</drugindication>
  </drug>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>SEVREDOL (MORPHINE SULFATE)</medicinalproduct>
     <drugdosagetext>ORAL</drugdosagetext>
     <drugadministrationroute>048</drugadministrationroute>
     <drugindication>PAIN NOS</drugindication>
  </drug>
 </patient>
 </safetyreport>
 </ichicsr>
