Adverse Event Report

Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10051659serious1Date Last Updated01/04/2014receiptdateformat102companynumbUS-ABBVIE-14P-163-1215977-00occurcountryUSseriousnessother1duplicate1Date Received01/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification1

Patient

Onset Age14Unit of Onset AgeyearsWeight71.3SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionIntestinal obstructionOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionAppendicitisOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionInfectionOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionOff label useOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionInjection site painOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionInjection site painOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionAbdominal painOutcomeRecovered/resolved

8)

reactionmeddraversionpt17.0ReactionIntestinal mucosal hypertrophyOutcomeRecovered/resolved

9)

reactionmeddraversionpt17.0ReactionEnteritisOutcomeRecovered/resolved

10)

reactionmeddraversionpt17.0ReactionLocalised intraabdominal fluid collectionOutcomeRecovered/resolved

11)

reactionmeddraversionpt17.0ReactionIleusOutcomeRecovered/resolved

12)

reactionmeddraversionpt17.0ReactionNauseaOutcomeRecovered/resolved

13)

reactionmeddraversionpt17.0ReactionVomitingOutcomeRecovered/resolved

14)

reactionmeddraversionpt17.0ReactionCrohn^s diseaseOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1009150drugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugdosageformSolution for injection in pre-filled pendrugindicationCROHN^S DISEASEdrugstartdateformat610drugstartdate/05/2013actiondrug1

openFDA Info on Medication

Application NumberBLA125057Brand NameHUMIRAGeneric NameADALIMUMABManufacturersAbbVie Inc.product_ndc 0074-0067, 0074-3799, 0074-6347, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 351290, 352334, 727703, 727705, 763564, 763565, 797544, 825169, 825170, 1551887, ... spl_id7a967019-f452-7b99-ba3d-e9b3ac703363spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

2)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1009150drugauthorizationnumb125057drugstructuredosagenumb160drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformSolution for injection in pre-filled pendrugstartdateformat102drugstartdate14/06/2013drugenddateformat102drugenddate14/06/2013actiondrug1

openFDA Info on Medication

Application NumberBLA125057Brand NameHUMIRAGeneric NameADALIMUMABManufacturersAbbVie Inc.product_ndc 0074-0067, 0074-3799, 0074-6347, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 351290, 352334, 727703, 727705, 763564, 763565, 797544, 825169, 825170, 1551887, ... spl_id7a967019-f452-7b99-ba3d-e9b3ac703363spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

3)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1009150drugauthorizationnumb125057drugstructuredosagenumb80drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformSolution for injection in pre-filled pendrugstartdateformat102drugstartdate27/08/2013actiondrug1

openFDA Info on Medication

Application NumberBLA125057Brand NameHUMIRAGeneric NameADALIMUMABManufacturersAbbVie Inc.product_ndc 0074-0067, 0074-3799, 0074-6347, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 351290, 352334, 727703, 727705, 763564, 763565, 797544, 825169, 825170, 1551887, ... spl_id7a967019-f452-7b99-ba3d-e9b3ac703363spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

4)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1009150drugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugdosageformSolution for injection in pre-filled pendrugstartdateformat102drugstartdate10/09/2013actiondrug1

openFDA Info on Medication

Application NumberBLA125057Brand NameHUMIRAGeneric NameADALIMUMABManufacturersAbbVie Inc.product_ndc 0074-0067, 0074-3799, 0074-6347, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 351290, 352334, 727703, 727705, 763564, 763565, 797544, 825169, 825170, 1551887, ... spl_id7a967019-f452-7b99-ba3d-e9b3ac703363spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

5)

drugcharacterization2medicinalproductZOLOFTdrugindicationDEPRESSION

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1215977-00

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use