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
1030064729 10300647 29 F 20140707 20160822 20140714 20160824 EXP CA-ROCHE-1284186 ROCHE 45.64 YR F Y 90.00000 KG 20160824 OT 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
1030064729 10300647 1 PS ACTEMRA TOCILIZUMAB 1 Intravenous (not otherwise specified) B20243,B2039,B2041,B2044 125276 640 MG SOLUTION FOR INFUSION
1030064729 10300647 2 SS ACTEMRA TOCILIZUMAB 1 Intravenous (not otherwise specified) B20243,B2039,B2041,B2044 125276 720 MG SOLUTION FOR INFUSION
1030064729 10300647 3 SS RITUXAN RITUXIMAB 1 Intravenous (not otherwise specified) DAY 1 AND DAY 15 B62402 103705 1000 MG SOLUTION FOR INFUSION
1030064729 10300647 4 SS ADALAT NIFEDIPINE 1 Unknown 0
1030064729 10300647 5 C DIPHENHYDRAMINE HCL DIPHENHYDRAMINE HYDROCHLORIDE 1 Oral 0 50 MG
1030064729 10300647 6 C ACETAMINOPHEN. ACETAMINOPHEN 1 Oral 0 650 MG
1030064729 10300647 7 C METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Intravenous (not otherwise specified) 0 100 MG
1030064729 10300647 8 C PREDNISONE. PREDNISONE 1 0
1030064729 10300647 9 C TYLENOL ACETAMINOPHEN 1 0
1030064729 10300647 10 C OMEPRAZOLE. OMEPRAZOLE 1 0
1030064729 10300647 11 C LEFLUNOMIDE. LEFLUNOMIDE 1 0
1030064729 10300647 12 C TWYNSTA AMLODIPINE BESYLATETELMISARTAN 1 0
1030064729 10300647 13 C XELJANZ TOFACITINIB CITRATE 1 Unknown 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
1030064729 10300647 1 Rheumatoid arthritis
1030064729 10300647 3 Rheumatoid arthritis
1030064729 10300647 4 Hypertension
1030064729 10300647 5 Premedication
1030064729 10300647 6 Premedication
1030064729 10300647 7 Premedication

Outcome of event

Event ID CASEID OUTC COD
1030064729 10300647 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
1030064729 10300647 Blood pressure inadequately controlled
1030064729 10300647 Blood pressure increased
1030064729 10300647 Cough
1030064729 10300647 Dyspepsia
1030064729 10300647 Headache
1030064729 10300647 Helicobacter infection
1030064729 10300647 Hypertension
1030064729 10300647 Hypoaesthesia
1030064729 10300647 Lower respiratory tract infection
1030064729 10300647 Nasopharyngitis
1030064729 10300647 Oxygen saturation decreased
1030064729 10300647 Pain in extremity
1030064729 10300647 Renal pain
1030064729 10300647 Syncope
1030064729 10300647 Tinnitus
1030064729 10300647 Tooth infection
1030064729 10300647 Upper respiratory tract infection
1030064729 10300647 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
1030064729 10300647 1 20140806 0
1030064729 10300647 2 20151217 20160706 0
1030064729 10300647 3 20130318 20131015 0
1030064729 10300647 4 201309 0
1030064729 10300647 5 20130318 20131015 0
1030064729 10300647 6 20130318 20131015 0
1030064729 10300647 7 20130318 20131015 0
1030064729 10300647 13 201507 0