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
119178083	11917808	3	F		20160901	20160114	20160914	EXP		LU-BIOGEN-2015BI138305	BIOGEN		0.00			M	Y	0.00000		20160914		MD	LU	LU

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
119178083	11917808	1	PS	TYSABRI	NATALIZUMAB	1	Intravenous (not otherwise specified)								125104	300	MG	CONCENTRATE FOR SOLUTION FOR INFUSION	/month
119178083	11917808	2	SS	TYSABRI	NATALIZUMAB	1	Intravenous (not otherwise specified)								125104	300	MG	CONCENTRATE FOR SOLUTION FOR INFUSION	/month

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
119178083	11917808	1	Multiple sclerosis

Outcome of event

Event ID	CASEID	OUTC COD
119178083	11917808	DE
119178083	11917808	OT

Reactions reported

Event ID	CASEID	PT
119178083	11917808	Hyperkalaemia
119178083	11917808	Hypernatraemia
119178083	11917808	Progressive multifocal leukoencephalopathy

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
119178083	11917808	1	200808	201406	0
119178083	11917808	2		201509	0