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
126897231	12689723	1	I	20160804	20160818	20160826	20160826	EXP		BR-ALEXION PHARMACEUTICALS INC-A201606220	ALEXION		74.48	YR		F	Y	0.00000		20160826		CN	BR	BR

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
126897231	12689723	1	PS	SOLIRIS	ECULIZUMAB	1	Intravenous (not otherwise specified)	600 MG, QW	132000	MG	U				125166	600	MG	CONCENTRATE FOR SOLUTION FOR INFUSION	/wk
126897231	12689723	2	SS	SOLIRIS	ECULIZUMAB	1	Intravenous (not otherwise specified)	900 MG, Q2W	132000	MG	U				125166	900	MG	CONCENTRATE FOR SOLUTION FOR INFUSION	QOW

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126897231	12689723	1	Paroxysmal nocturnal haemoglobinuria

Outcome of event

Event ID	CASEID	OUTC COD
126897231	12689723	DS
126897231	12689723	OT

Reactions reported

Event ID	CASEID	PT
126897231	12689723	Abdominal pain
126897231	12689723	Asthenia
126897231	12689723	Blood iron increased
126897231	12689723	Dysphagia
126897231	12689723	Dysuria
126897231	12689723	Haemoglobinuria
126897231	12689723	Haemolysis
126897231	12689723	Tracheal pain

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
126897231	12689723	1	20101109	20101130	0
126897231	12689723	2	20101207	20160722	0