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
110688182	11068818	2	F	2014	20160713	20150427	20160722	EXP		FR-ABBVIE-15K-056-1378383-00	ABBVIE		28.56	YR		F	Y	0.00000		20160722		MD	FR	FR

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
110688182	11068818	1	PS	HUMIRA	ADALIMUMAB	1	Subcutaneous				Y	Y	UNKNOWN		125057			SOLUTION FOR INJECTION
110688182	11068818	2	SS	HUMIRA	ADALIMUMAB	1	Subcutaneous				Y	Y	UNKNOWN		125057			SOLUTION FOR INJECTION

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
110688182	11068818	1	Crohn's disease

Outcome of event

Event ID	CASEID	OUTC COD
110688182	11068818	HO

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
110688182	11068818		Antinuclear antibody increased
110688182	11068818		Arthralgia
110688182	11068818	Hypersensitivity vasculitis	Hypersensitivity vasculitis
110688182	11068818		Oedema
110688182	11068818		Purpura

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	DUR	DUR COD
110688182	11068818	1	20111207	201412	0
110688182	11068818	2	201508	201512	0