<ichicsr lang="en">
 <ichicsrmessageheader>
  <messagetype>ICSR</messagetype>
  <messageformatversion>2.1</messageformatversion>
  <messageformatrelease>1.0</messageformatrelease>
  <messagenumb>2005-07</messagenumb>
  <messagesenderidentifier>FDA CDER ODS</messagesenderidentifier>
  <messagereceiveridentifier>Public Use</messagereceiveridentifier>
  <messagedateformat>204</messagedateformat>
  <messagedate>2006021803:13:15</messagedate>
 </ichicsrmessageheader>
  <safetyreport>
   <safetyreportid>4627939-6</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20060218</transmissiondate>
   <serious>1</serious>
   <seriousnesshospitalization>1</seriousnesshospitalization>
   <receivedateformat>102</receivedateformat>
   <receivedate>20050401</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20050318</receiptdate>
   <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
   <companynumb>029-05</companynumb>
  <primarysource>
     <reportercountry>UNITED STATES</reportercountry>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientonsetage>74</patientonsetage>
     <patientonsetageunit>801</patientonsetageunit>
     <patientsex>1</patientsex>
  <reaction>
     <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE ABNORMAL</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>CONTUSION</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>FALL</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>AMIODARONE HCL</medicinalproduct>
     <drugauthorizationnumb>75315</drugauthorizationnumb>
     <drugdosagetext>200 MG QD PO</drugdosagetext>
     <drugadministrationroute>048</drugadministrationroute>
     <drugindication>ATRIAL FIBRILLATION</drugindication>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>ZOCOR</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>PRILOSEC</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>XANAX</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>FLOVENT</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>SEREVENT</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>FLOMAX</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>LEVOXYL</medicinalproduct>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>4628736-8</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20060218</transmissiondate>
   <serious>1</serious>
   <seriousnesshospitalization>1</seriousnesshospitalization>
   <receivedateformat>102</receivedateformat>
   <receivedate>20050406</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20050323</receiptdate>
   <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
   <companynumb>03-000513</companynumb>
  <primarysource>
     <reportercountry>UNITED STATES</reportercountry>
     <qualification>1</qualification>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientsex>2</patientsex>
  <reaction>
     <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>FEMHRT</medicinalproduct>
     <drugauthorizationnumb>21065</drugauthorizationnumb>
     <drugdosagetext>5/1000 UG QD, ORAL</drugdosagetext>
     <drugadministrationroute>048</drugadministrationroute>
     <drugindication>NIGHT SWEATS</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20031001</drugstartdate>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>4629569-9</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20060218</transmissiondate>
   <serious>1</serious>
   <seriousnessdeath>1</seriousnessdeath>
   <receivedateformat>102</receivedateformat>
   <receivedate>20050406</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20050317</receiptdate>
   <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
   <companynumb>THYM-10442</companynumb>
  <primarysource>
     <reportercountry>GERMANY</reportercountry>
     <qualification>1</qualification>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientonsetage>56</patientonsetage>
     <patientonsetageunit>801</patientonsetageunit>
     <patientweight>97</patientweight>
     <patientsex>1</patientsex>
    <patientdeath>
     <patientdeathdateformat>102</patientdeathdateformat>
     <patientdeathdate>20050107</patientdeathdate>
    </patientdeath>
  <reaction>
     <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>SEPSIS</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
     <drugdosagetext>175 MG QD IV</drugdosagetext>
     <drugadministrationroute>042</drugadministrationroute>
     <drugindication>STEM CELL TRANSPLANT</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20041106</drugstartdate>
     <drugenddateformat>102</drugenddateformat>
     <drugenddate>20041108</drugenddate>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>TREOSULFAN</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>FLUDARABIN</medicinalproduct>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>4629632-2</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20060218</transmissiondate>
   <serious>1</serious>
   <seriousnesshospitalization>1</seriousnesshospitalization>
   <seriousnessother>1</seriousnessother>
   <receivedateformat>102</receivedateformat>
   <receivedate>20050406</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20050324</receiptdate>
   <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
   <companynumb>2005023892</companynumb>
  <primarysource>
     <reportercountry>JAPAN</reportercountry>
     <qualification>2</qualification>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientonsetage>67</patientonsetage>
     <patientonsetageunit>801</patientonsetageunit>
     <patientsex>2</patientsex>
  <reaction>
     <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>NAUSEA</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>ATARAX</medicinalproduct>
     <drugauthorizationnumb>11111</drugauthorizationnumb>
     <drugdosagetext>25 MG (1 D) INTRAMUSCULAR</drugdosagetext>
     <drugadministrationroute>030</drugadministrationroute>
     <drugindication>ILL-DEFINED DISORDER</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20050128</drugstartdate>
     <drugenddateformat>102</drugenddateformat>
     <drugenddate>20050128</drugenddate>
  </drug>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
     <drugdosagetext>15 MG (15 MG, 1 IN 1D), INTRAMUSCULAR</drugdosagetext>
     <drugadministrationroute>030</drugadministrationroute>
     <drugindication>ILL-DEFINED DISORDER</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20050128</drugstartdate>
  </drug>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>DROPERIDOL</medicinalproduct>
     <drugdosagetext>1 ML (1 ML, 1 IN 1 D), INTRAVENOUS</drugdosagetext>
     <drugadministrationroute>042</drugadministrationroute>
     <drugindication>ILL-DEFINED DISORDER</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20050128</drugstartdate>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>NIFEDIPINE</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>TEPRENONE (TEPRENONE)</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>NICERITROL (NICERITROL)</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>ASPIRIN</medicinalproduct>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>4629872-2</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20060218</transmissiondate>
   <serious>1</serious>
   <seriousnesshospitalization>1</seriousnesshospitalization>
   <receivedateformat>102</receivedateformat>
   <receivedate>20050407</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20050324</receiptdate>
   <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
   <companynumb>2005042086</companynumb>
  <primarysource>
     <reportercountry>JAPAN</reportercountry>
     <qualification>1</qualification>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientonsetage>56</patientonsetage>
     <patientonsetageunit>801</patientonsetageunit>
     <patientsex>1</patientsex>
  <reaction>
     <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>ELECTROCARDIOGRAM R ON T PHENOMENON</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>SINOATRIAL BLOCK</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>VIRACEPT</medicinalproduct>
     <drugauthorizationnumb>20779</drugauthorizationnumb>
     <drugdosagetext>ORAL</drugdosagetext>
     <drugadministrationroute>048</drugadministrationroute>
     <drugindication>HIV INFECTION</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20030425</drugstartdate>
  </drug>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>DIDANOSINE</medicinalproduct>
     <drugdosagetext>400 MG (1 IN 1 D), ORAL</drugdosagetext>
     <drugadministrationroute>048</drugadministrationroute>
     <drugindication>HIV INFECTION</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20020716</drugstartdate>
     <drugenddateformat>102</drugenddateformat>
     <drugenddate>20030409</drugenddate>
  </drug>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>LAMIVUDINE</medicinalproduct>
     <drugdosagetext>300 MG (150 MG, 2 IN 1 D), ORAL</drugdosagetext>
     <drugadministrationroute>048</drugadministrationroute>
     <drugindication>HIV INFECTION</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20010208</drugstartdate>
     <drugenddateformat>102</drugenddateformat>
     <drugenddate>20030409</drugenddate>
  </drug>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>ABACAVIR (ABACAVIR)</medicinalproduct>
     <drugdosagetext>600 MG (1 IN 1 D), ORAL</drugdosagetext>
     <drugadministrationroute>048</drugadministrationroute>
     <drugindication>HIV INFECTION</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20010406</drugstartdate>
     <drugenddateformat>102</drugenddateformat>
     <drugenddate>20030409</drugenddate>
  </drug>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>EFAVIRENZ (EFAVIRENZ)</medicinalproduct>
     <drugdosagetext>600 MG (1 IN 1 D), ORAL</drugdosagetext>
     <drugadministrationroute>048</drugadministrationroute>
     <drugindication>HIV INFECTION</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20010323</drugstartdate>
  </drug>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>KALETRA</medicinalproduct>
     <drugdosagetext>ORAL</drugdosagetext>
     <drugadministrationroute>048</drugadministrationroute>
     <drugindication>HIV INFECTION</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20020513</drugstartdate>
     <drugenddateformat>102</drugenddateformat>
     <drugenddate>20020715</drugenddate>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE)</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>ALL OTHER THERAPETIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>BACTRIM</medicinalproduct>
  </drug>
  </patient>
  </safetyreport>
  <safetyreport>
   <safetyreportid>4631467-1</safetyreportid>
   <transmissiondateformat>102</transmissiondateformat>
   <transmissiondate>20060218</transmissiondate>
   <serious>1</serious>
   <seriousnesshospitalization>1</seriousnesshospitalization>
   <receivedateformat>102</receivedateformat>
   <receivedate>20050407</receivedate>
   <receiptdateformat>102</receiptdateformat>
   <receiptdate>20050401</receiptdate>
   <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
   <companynumb>2005P1000017</companynumb>
  <primarysource>
     <reportercountry>KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF</reportercountry>
  </primarysource>
  <sender>
    <senderorganization>FDA-Public Use</senderorganization>
  </sender>
  <receiver>
  </receiver>
  <patient>
     <patientonsetage>15</patientonsetage>
     <patientonsetageunit>801</patientonsetageunit>
     <patientsex>2</patientsex>
  <reaction>
     <reactionmeddrapt>COMPLICATIONS OF BONE MARROW TRANSPLANT</reactionmeddrapt>
  </reaction>
  <reaction>
     <reactionmeddrapt>DELAYED ENGRAFTMENT</reactionmeddrapt>
  </reaction>
  <drug>
     <drugcharacterization>1</drugcharacterization>
     <medicinalproduct>BUSULFEX</medicinalproduct>
     <drugauthorizationnumb>9386</drugauthorizationnumb>
     <drugdosagetext>164 MG/DAY (42 MG/DOSE X 4 TIMES)</drugdosagetext>
     <drugadministrationroute>042</drugadministrationroute>
     <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
     <drugstartdateformat>102</drugstartdateformat>
     <drugstartdate>20030205</drugstartdate>
     <drugenddateformat>102</drugenddateformat>
     <drugenddate>20030505</drugenddate>
     <drugtreatmentduration>4</drugtreatmentduration>
     <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>MESNA</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>PHENYTOIN</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>ZOFRAN</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>GANCICLOVIR</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>ANTIBIOTICS (VANCOMYCIN, MEROPENEM, CEFTAZIDIME, CIPROFLOXACIN, ETC)</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>ANTIFUNGALS (AMPHOTERICIN-B, DIFLUCAN)</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>IMMUNOSUPRESSANTS</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>HEPARIN</medicinalproduct>
  </drug>
  <drug>
     <drugcharacterization>2</drugcharacterization>
     <medicinalproduct>GRASIN</medicinalproduct>
  </drug>
  </patient>
  </safetyreport>