Safety Rates Drug Report: adverse events in 2016 Q3 - FDA prescription drugs adverse events in an open, searchable, online, public database

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
126394532	12639453	2	F	201605	20160816	20160810	20160819	EXP		TW-ROCHE-1810896	ROCHE		82.26	YR		M	Y	0.00000		20160819		MD	TW	TW

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
126394532	12639453	1	PS	MABTHERA	RITUXIMAB	1	Intravenous drip	1ST CYCLE	103705	1000	MG	SOLUTION FOR INFUSION	/wk
126394532	12639453	2	SS	MABTHERA	RITUXIMAB	1	Intravenous drip	2ND CYCLE	103705	1000	MG	SOLUTION FOR INFUSION	/wk
126394532	12639453	3	SS	MABTHERA	RITUXIMAB	1	Intravenous drip	3RD CYCLE	103705	1000	MG	SOLUTION FOR INFUSION	/wk

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126394532	12639453	1	Microscopic polyangiitis

Outcome of event

Event ID	CASEID	OUTC COD
126394532	12639453	DE

Reactions reported

Event ID	CASEID	PT
126394532	12639453	Cardiac failure
126394532	12639453	Respiratory failure
126394532	12639453	Sepsis
126394532	12639453	Vasculitis

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

no results found

no results found

Therapies reported

Event ID	CASEID	DSG DRUG SEQ	START DT	END DT
126394532	12639453	1	20130920	20141011
126394532	12639453	2	20150815	20150905
126394532	12639453	3	20160308	20160329