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
123904152	12390415	2	F	20160304	20160712	20160520	20160718	EXP		CO-ALEXION PHARMACEUTICALS INC-A201603652	ALEXION		66.00	YR		M	Y	0.00000		20160718		CN	CO	CO

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
123904152	12390415	1	PS	SOLIRIS	ECULIZUMAB	1	Intravenous (not otherwise specified)	600 MG, QW	13727.2725	MG	N		AE1235B05		125166	600	MG	CONCENTRATE FOR SOLUTION FOR INFUSION	/wk
123904152	12390415	2	SS	SOLIRIS	ECULIZUMAB	1	Intravenous (not otherwise specified)	900 MG, Q2W	13727.2725	MG	N		AE1235B05		125166	900	MG	CONCENTRATE FOR SOLUTION FOR INFUSION	QOW

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
123904152	12390415	1	Paroxysmal nocturnal haemoglobinuria

Outcome of event

Event ID	CASEID	OUTC COD
123904152	12390415	OT
123904152	12390415	HO

Reactions reported

Event ID	CASEID	PT
123904152	12390415	Drug ineffective
123904152	12390415	Haemoglobin decreased
123904152	12390415	Inappropriate schedule of drug administration

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
123904152	12390415	1	20151112	20151204	0
123904152	12390415	2	20151215	20160629	0