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
125312682	12531268	2	F	20160527	20160718	20160706	20160720	EXP		FR-JNJFOC-20160701815	JANSSEN		76.77	YR	E	M	Y	60.00000	KG	20160720		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
125312682	12531268	1	PS	DARATUMUMAB	DARATUMUMAB	1	Intravenous (not otherwise specified)					N			761036	16	MG/KG	CONCENTRATE FOR SOLUTION FOR INFUSION
125312682	12531268	2	SS	DEXAMETHASONE.	DEXAMETHASONE	1	Intravenous (not otherwise specified)								0	20	MG		/wk

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125312682	12531268	1	Plasma cell myeloma
125312682	12531268	2	Plasma cell myeloma

Outcome of event

Event ID	CASEID	OUTC COD
125312682	12531268	LT
125312682	12531268	DE

Reactions reported

Event ID	CASEID	PT
125312682	12531268	Lung disorder
125312682	12531268	Off label use
125312682	12531268	Septic shock

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
125312682	12531268	1	20160507	20160521	0
125312682	12531268	2	20160507	20160521	0