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
125431561 12543156 1 I 20150901 20160519 20160711 20160711 EXP DE-ROCHE-1761464 ROCHE 12.68 YR M Y 47.90000 KG 20160711 MD DE DE

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
125431561 12543156 1 PS Tocilizumab TOCILIZUMAB 1 Intravenous (not otherwise specified) 125276 400 MG
125431561 12543156 2 SS Tocilizumab TOCILIZUMAB 1 125276
125431561 12543156 3 SS CANAKINUMAB CANAKINUMAB 1 Intravenous (not otherwise specified) 0 150 MG
125431561 12543156 4 C NAPROXEN. NAPROXEN 1 Oral 0 500 MG QD
125431561 12543156 5 C NAPROXEN. NAPROXEN 1 Oral 0 60 MG
125431561 12543156 6 C PREDNISON PREDNISONE 1 Oral 0 5 MG QD
125431561 12543156 7 C METHOTREXATE. METHOTREXATE 1 Unknown 0 1 DF /wk
125431561 12543156 8 C METAMIZOL METAMIZOLE SODIUM 1 Oral 0 500 MG TID

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125431561 12543156 1 Juvenile idiopathic arthritis
125431561 12543156 2 Juvenile idiopathic arthritis
125431561 12543156 3 Juvenile idiopathic arthritis
125431561 12543156 4 Juvenile idiopathic arthritis
125431561 12543156 6 Juvenile idiopathic arthritis
125431561 12543156 7 Juvenile idiopathic arthritis

Outcome of event

Event ID CASEID OUTC COD
125431561 12543156 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
125431561 12543156 Abdominal pain upper
125431561 12543156 Faecal calprotectin increased
125431561 12543156 Juvenile idiopathic arthritis
125431561 12543156 Sudden hearing loss

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

no results found

Therapies reported

Event ID CASEID DSG DRUG SEQ START DT END DT DUR DUR COD
125431561 12543156 1 20150601 20160111 0
125431561 12543156 3 20160208 0
125431561 12543156 4 20150601 0
125431561 12543156 5 201602 0
125431561 12543156 6 20150601 0
125431561 12543156 7 20070801 20090901 0
125431561 12543156 8 201602 0