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
934545233 9345452 33 F 201305 20160902 20130613 20160907 EXP CA-ROCHE-1224960 ROCHE 21.35 YR F Y 50.00000 KG 20160907 MD CA CA

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
934545233 9345452 1 PS ACTEMRA TOCILIZUMAB 1 Intravenous (not otherwise specified) B20121,B20192,B20262,B2034B063,B202 125276 365 MG SOLUTION FOR INFUSION
934545233 9345452 2 SS ACTEMRA TOCILIZUMAB 1 Intravenous (not otherwise specified) B20121,B20192,B20262,B2034B063,B202 125276 384 MG SOLUTION FOR INFUSION QOW
934545233 9345452 3 SS ACTEMRA TOCILIZUMAB 1 Intravenous (not otherwise specified) B20121,B20192,B20262,B2034B063,B202 125276 344 MG SOLUTION FOR INFUSION QOW
934545233 9345452 4 SS ACTEMRA TOCILIZUMAB 1 Intravenous (not otherwise specified) B20121,B20192,B20262,B2034B063,B202 125276 376 MG SOLUTION FOR INFUSION QOW
934545233 9345452 5 SS ACTEMRA TOCILIZUMAB 1 Intravenous (not otherwise specified) B20121,B20192,B20262,B2034B063,B202 125276 560 MG SOLUTION FOR INFUSION QOW
934545233 9345452 6 SS ACTEMRA TOCILIZUMAB 1 Intravenous (not otherwise specified) B20121,B20192,B20262,B2034B063,B202 125276 384 MG SOLUTION FOR INFUSION QOW
934545233 9345452 7 SS ACTEMRA TOCILIZUMAB 1 Intravenous (not otherwise specified) B20121,B20192,B20262,B2034B063,B202 125276 392 MG SOLUTION FOR INFUSION QOW
934545233 9345452 8 SS PREDNISONE. PREDNISONE 1 Oral 0
934545233 9345452 9 SS PREDNISONE. PREDNISONE 1 Oral 0 10 MG
934545233 9345452 10 SS PREDNISONE. PREDNISONE 1 Oral 0 20 MG
934545233 9345452 11 C METHOTREXATE. METHOTREXATE 1 0
934545233 9345452 12 C PLAQUENIL HYDROXYCHLOROQUINE SULFATE 1 0
934545233 9345452 13 C FOLIC ACID. FOLIC ACID 1 0
934545233 9345452 14 C LOSEC OMEPRAZOLE 1 0
934545233 9345452 15 C NAPROSYN NAPROXEN 1 Unknown 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
934545233 9345452 1 Rheumatoid arthritis
934545233 9345452 8 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
934545233 9345452 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
934545233 9345452 Abdominal pain
934545233 9345452 Acne
934545233 9345452 Arthralgia
934545233 9345452 Carpal tunnel syndrome
934545233 9345452 Cough
934545233 9345452 Diarrhoea
934545233 9345452 Drug ineffective
934545233 9345452 Dry skin
934545233 9345452 Gait disturbance
934545233 9345452 Infusion related reaction
934545233 9345452 Infusion site extravasation
934545233 9345452 Musculoskeletal pain
934545233 9345452 Musculoskeletal stiffness
934545233 9345452 Nasal congestion
934545233 9345452 Nasopharyngitis
934545233 9345452 Oedema
934545233 9345452 Oral herpes
934545233 9345452 Rhinorrhoea
934545233 9345452 Vomiting
934545233 9345452 Weight decreased
934545233 9345452 Weight increased

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
934545233 9345452 1 20130412 0
934545233 9345452 2 20130805 0
934545233 9345452 3 20140206 0
934545233 9345452 4 20140424 0
934545233 9345452 5 20140507 0
934545233 9345452 6 20140522 0
934545233 9345452 7 20140627 0
934545233 9345452 9 20130507 0