The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASEID CASEVERSION I F COD EVENT DT MFR DT INIT FDA DT FDA DT REPT COD AUTH NUM MFR NUM MFR SNDR LIT REF AGE AGE COD AGE GRP GNDR COD E SUB WT WT COD REPT DT TO MFR OCCP COD REPORTER COUNTRY OCCR COUNTRY
127503472 12750347 2 F 20160915 20160916 20160922 EXP US-JNJFOC-20160913858 JANSSEN CHALHOUB N, GEORGESCU C, ALTOROK C. MYCOBACTERIUM AVIUM COMPLEX SEPTIC ARTHRITIS IN A PATIENT TREATED BY INFLIXIMAB. AMERICAN JOURNAL OF THERAPEUTICS 2016;23 (5):E1222-5. 50.00 YR A F Y 0.00000 20160922 OT US US

Drug(s) used by person

Event ID CASEID DRUG SEQ ROLE COD DRUGNAME PROD AI VAL VBM ROUTE DOSE VBM CUM DOSE CHR CUM DOSE UNIT DECHAL RECHAL LOT NUM EXP DT NDA NUM DOSE AMT DOSE UNIT DOSE FORM DOSE FREQ
127503472 12750347 1 PS INFLIXIMAB, RECOMBINANT INFLIXIMAB 1 Intravenous (not otherwise specified) N 103772 LYOPHILIZED POWDER
127503472 12750347 2 SS METHOTREXATE. METHOTREXATE 1 Unknown D 0 UNKNOWN
127503472 12750347 3 SS PREDNISONE. PREDNISONE 1 Unknown D 0 UNKNOWN

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127503472 12750347 1 Dermatomyositis
127503472 12750347 2 Dermatomyositis
127503472 12750347 3 Dermatomyositis

Outcome of event

Event ID CASEID OUTC COD
127503472 12750347 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
127503472 12750347 Arthritis bacterial
127503472 12750347 Mycobacterium avium complex infection
127503472 12750347 Off label use
127503472 12750347 Product use issue

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

no results found