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
100168404 10016840 4 F 201312 20160808 20140318 20160810 EXP BR-ROCHE-1347922 ROCHE 30.32 YR F Y 52.00000 KG 20160810 MD BR BR

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
100168404 10016840 1 PS MABTHERA RITUXIMAB 1 Intravenous (not otherwise specified) 103705 SOLUTION FOR INFUSION /yr
100168404 10016840 2 SS MABTHERA RITUXIMAB 1 103705
100168404 10016840 3 SS MABTHERA RITUXIMAB 1 103705
100168404 10016840 4 C OMEPRAZOLE. OMEPRAZOLE 1 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
100168404 10016840 1 Rheumatoid arthritis
100168404 10016840 2 Systemic scleroderma
100168404 10016840 3 Pulmonary fibrosis
100168404 10016840 4 Gastric disorder

Outcome of event

Event ID CASEID OUTC COD
100168404 10016840 DE
100168404 10016840 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
100168404 10016840 Blood pressure increased
100168404 10016840 Depression
100168404 10016840 Off label use
100168404 10016840 Pyrexia
100168404 10016840 Respiratory failure
100168404 10016840 Somnolence

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
100168404 10016840 1 20131118 20150815 0