Individual Case Safety Report Specifications

<A.1.0.1-safetyreportversion />

<A.1.0.1-safetyreportid />

<A.1.1-primarysourcecountry />

<A.1.2-occurcountry />

<A.1.3a-transmissiondateformat />

<A.1.3b-transmissiondate />

<A.1.4-reporttype />

<A.1.5.1-serious />

<A.1.5.2a-seriousnessdeath />

<A.1.5.2b-seriousnesslifethreatening />

<A.1.5.2c-seriousnesshospitalization />

<A.1.5.2d-seriousnessdisabling />

<A.1.5.2e-seriousnesscongenitalanomali />

<A.1.5.2f-seriousnessother />

<A.1.6.a-receivedateformat />

<A.1.6.b-receivedate />

<A.1.7.a-receiptdateformat />

<A.1.7.b-receiptdate />

<A.1.8.1-additionaldocument />

<A.1.8.2-documentlist />

<A.1.9-fulfillexpeditecriteria />

<A.1.10.1-authoritynumb />

<A.1.10.2-companynumb />

<A.1.11-duplicate />

<A.1.13-casenullification />

<A.1.13.1-nullificationreason />

<A.1.14-medicallyconfirm />

- <reportduplicate>

<A.1.11.1-duplicatesource />

<A.1.11.2-duplicatenumb />

</reportduplicate>

- <linkedreport>

<A.1.12-linkreportnumb />

</linkedreport>

- <primarysource>

<A.2.1.1a-reportertitle />

<A.2.1.1b-reportergivename />

<A.2.1.1c-reportermiddlename />

<A.2.1.1d-reporterfamilyname />

<A.2.1.2a-reporterorganization />

<A.2.1.2b-reporterdepartment />

<A.2.1.2c-reporterstreet />

<A.2.1.2d-reportercity />

<A.2.1.2e-reporterstate />

<A.2.1.2f-reporterpostcode />

<A.2.1.3-reportercountry />

<A.2.1.4-qualification />

<A.2.2-literaturereference />

<A.2.3.1-studyname />

<A.2.3.2-sponsorstudynumb />

<A.2.3.3-observestudytype />

</primarysource>

- <sender>

<A.3.1.1-sendertype />

<A.3.1.2-senderorganization />

<A.3.1.3a-senderdepartment />

<A.3.1.3b-sendertitle />

<A.3.1.3c-sendergivename />

<A.3.1.3d-sendermiddlename />

<A.3.1.3e-senderfamilyname />

<A.3.1.4a-senderstreetaddress />

<A.3.1.4b-sendercity />

<A.3.1.4c-senderstate />

<A.3.1.4d-senderpostcode />

<A.3.1.4e-sendercountrycode />

<A.3.1.4f-sendertel />

<A.3.1.4g-sendertelextension />

<A.3.1.4h-sendertelcountrycode />

<A.3.1.4i-senderfax />

<A.3.1.4j-senderfaxextension />

<A.3.1.4k-senderfaxcountrycode />

<A.3.1.4l-senderemailaddress />

</sender>

- <receiver>

<A.3.2.1-receivertype />

<A.3.2.2a-receiverorganization />

<A.3.2.2b-receiverdepartment />

<A.3.2.2c-receivertitle />

<A.3.2.2d-receivergivename />

<A.3.2.2e-receivermiddlename />

<A.3.2.2f-receiverfamilyname />

<A.3.2.3a-receiverstreetaddress />

<A.3.2.3b-receivercity />

<A.3.2.3c-receiverstate />

<A.3.2.3d-receiverpostcode />

<A.3.2.3e-receivercountrycode />

<A.3.2.3f-receivertel />

<A.3.2.3g-receivertelextension />

<A.3.2.3h-receivertelcountrycode />

<A.3.2.3i-receiverfax />

<A.3.2.3j-receiverfaxextension />

<A.3.2.3k-receiverfaxcountrycode />

<A.3.2.3l-receiveremailaddress />

</receiver>

- <patient>

<B.1.1-patientinitial />

<B.1.1.1a-patientgpmedicalrecordnumb />

<B.1.1.1b-patientspecialistrecordnumb />

<B.1.1.1b-patienthospitalrecordnumb />

<B.1.1.1d-patientinvestigationnumb />

<B.1.2.1a-patientbirthdateformat />

<B.1.2.1b-patientbirthdate />

<B.1.2.2a-patientonsetage />

<B.1.2.2b-patientonsetageunit />

<B.1.2.2.1a-gestationperiod />

<B.1.2.2.1b-gestationperiodunit />

<B.1.2.3-patientagegroup />

<B.1.3-patientweight />

<B.1.4-patientheight />

<B.1.5-patientsex />

<B.1.6a-lastmenstrualdateformat />

<B.1.6b-patientlastmenstrualdate />

<B.1.7.2-patientmedicalhistorytext />

<B.3.2-resultstestsprocedures />

- <medicalhistoryepisode>

<B.1.7.1a.1-patientepisodenamemeddraversion />

<B.1.7.1a.2-patientepisodename />

<B.1.7.1b-patientmedicalstartdateformat />

<B.1.7.1c-patientmedicalstartdate />

<B.1.7.1d-patientmedicalcontinue />

<B.1.7.1e-patientmedicalenddateformat />

<B.1.7.1f-patientmedicalenddate />

<B.1.7.1g-patientmedicalcomment />

</medicalhistoryepisode>

- <patientpastdrugtherapy>

<B.1.8a-patientdrugname />

<B.1.8b-patientdrugstartdateformat />

<B.1.8c-patientdrugstartdate />

<B.1.8d-patientdrugenddateformat />

<B.1.8e-patientdrugenddate />

<B.1.8f.1-patientindicationmeddraversion />

<B.1.8f.2-patientdrugindication />

<B.1.8g.1-patientdrgreactionmeddraversion />

<B.1.8g.2-patientdrugreaction />

</patientpastdrugtherapy>

- <patientdeath>

<B.1.9.1a-patientdeathdateformat />

<B.1.9.1b-patientdeathdate />

<B.1.9.3-patientautopsyyesno />

- <patientdeathcause>

<B.1.9.2.a-patientdeathreportmeddraversion />

<B.1.9.2.b-patientdeathreport />

</patientdeathcause>

- <patientautopsy>

<B.1.9.4a-patientdetermautopsmeddraversion />

<B.1.9.4b-patientdetermineautopsy />

</patientautopsy>

</patientdeath>

- <parent>

<B.1.10.1-parentidentification />

<B.1.10.2.1a-parentbirthdateformat />

<B.1.10.2.1b-parentbirthdate />

<B.1.10.2.2a-parentage />

<B.1.10.2.2b-parentageunit />

<B.1.10.3a-parentlastmenstrualdateformat />

<B.1.10.3b-parentlastmenstrualdate />

<B.1.10.4-parentweight />

<B.1.10.5-parentheight />

<B.1.10.6-parentsex />

<B.1.10.7.2-parentmedicalrelevanttext />

- <parentmedicalhistoryepisode>

<B.1.10.7.1a.1-parentmdepisodemeddraversion />

<B.1.10.7.1a.2-parentmedicalepisodename />

<B.1.10.7.1b-parentmedicalstartdateformat />

<B.1.10.7.1c-parentmedicalstartdate />

<B.1.10.7.1d-parentmedicalcontinue />

<B.1.10.7.1e-parentmedicalenddateformat />

<B.1.10.7.1f-parentmedicalenddate />

<B.1.10.7.1g-parentmedicalcomment />

</parentmedicalhistoryepisode>

- <parentpastdrugtherapy>

<B.1.10.8a-parentdrugname />

<B.1.10.8b-parentdrugstartdateformat />

<B.1.10.8c-parentdrugstartdate />

<B.1.10.8d-parentdrugenddateformat />

<B.1.10.8e-parentdrugenddate />

<B.1.10.8f.1-parentdrgindicationmeddraversion />

<B.1.10.8f.2-parentdrugindication />

<B.1.10.8g.1-parentdrgreactionmeddraversion />

<B.1.10.8g-parentdrugreaction />

</parentpastdrugtherapy>

</parent>

- <reaction>

<B.2.i.0-primarysourcereaction />

<B.2.i.1.a-reactionmeddraversionllt />

<B.2.i.1.b-reactionmeddrallt />

<B.2.i.2.a-reactionmeddraversionpt />

<B.2.i.2.b-reactionmeddrapt />

<B.2.i.3-termhighlighted />

<B.2.i.4a-reactionstartdateformat />

<B.2.i.4b-reactionstartdate />

<B.2.i.5a-reactionenddateformat />

<B.2.i.5b-reactionenddate />

<B.2.i.6a-reactionduration />

<B.2.i.6b-reactiondurationunit />

<B.2.i.7.1a-reactionfirsttime />

<B.2.i.7.1b-reactionfirsttimeunit />

<B.2.i.7.2a-reactionlasttime />

<B.2.i.7.2b-reactionlasttimeunit />

<B.2.i.8-reactionoutcome />

</reaction>

- <test>

<B.3.1a-testdateformat />

<B.3.1b-testdate />

<B.3.1c-testname />

<B.3.1d-testresult />

<B.3.1e-testunit />

<B.3.1.1-lowtestrange />

<B.3.1.2-hightestrange />

<B.3.1.3-moreinformation />

</test>

- <drug>

<B.4.k.1-drugcharacterization />

<B.4.k.2.1-medicinalproduct />

<B.4.k.2.3-obtaindrugcountry />

<B.4.k.3-drugbatchnumb />

<B.4.k.4.1-drugauthorizationnumb />

<B.4.k.4.2-drugauthorizationcountry />

<B.4.k.4.3-drugauthorizationholder />

<B.4.k.5.1-drugstructuredosagenumb />

<B.4.k.5.2-drugstructuredosageunit />

<B.4.k.5.3-drugseparatedosagenumb />

<B.4.k.5.4-drugintervaldosageunitnumb />

<B.4.k.5.5-drugintervaldosagedefinition />

<B.4.k.5.6-drugcumulativedosagenumb />

<B.4.k.5.7-drugcumulativedosageunit />

<B.4.k.6-drugdosagetext />

<B.4.k.7-drugdosageform />

<B.4.k.8-drugadministrationroute />

<B.4.k.9-drugparadministration />

<B.4.k.10a-reactiongestationperiod />

<B.4.k.10b-reactiongestationperiodunit />

<B.4.k.11a-drugindicationmeddraversion />

<B.4.k.11b-drugindication />

<B.4.k.12a-drugstartdateformat />

<B.4.k.12b-drugstartdate />

<B.4.k.13.1a-drugstartperiod />

<B.4.k.13.1b-drugstartperiodunit />

<B.4.k.13.2a-druglastperiod />

<B.4.k.13.2b-druglastperiodunit />

<B.4.k.14a-drugenddateformat />

<B.4.k.14b-drugenddate />

<B.4.k.15a-drugtreatmentduration />

<B.4.k.15b-drugtreatmentdurationunit />

<B.4.k.16-actiondrug />

<B.4.k.17.1-drugrecurreadministration />

<B.4.k.19-drugadditional />

- <activesubstance>

<B.4.k.2.2-activesubstancename />

</activesubstance>

- <drugrecurrence>

<B.4.k.17.2a-drugrecuractionmeddraversion />

<B.4.k.17.2b-rugrecuraction />

</drugrecurrence>

- <drugreactionrelatedness>

<B.4.k.18.1a-drugreactionassesmeddraversion />

<B.4.k.18.1-drugreactionasses />

<B.4.k.18.2-drugassessmentsource />

<B.4.k.18.3-drugassessmentmethod />

<B.4.k.18.4-drugresult />

</drugreactionrelatedness>

</drug>

- <summary>

<B.5.1-narrativeincludeclinical />

<B.5.2-reportercomment />

<B.5.3a-senderdiagnosismeddraversion />

<B.5.3b-senderdiagnosis />

<B.5.4-sendercomment />

</summary>

</patient>