Safety Rates Drug Report: adverse events in 2015 Q4 - 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
105298556	10529855	6	F	2014	20151222	20141021	20151231	EXP		US-SA-2014SA141634	AVENTIS		67.00	YR	E	M	Y	0.00000		20151231		CN	US	US

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
105298556	10529855	1	PS	CEREZYME	IMIGLUCERASE	1	Intravenous drip						UNKNOWN		20367	4800	MG	POWDER FOR SOLUTION FOR INFUSION	QOW
105298556	10529855	2	SS	CEREZYME	IMIGLUCERASE	1	Intravenous drip						C4280C01		20367	4800	MG	POWDER FOR SOLUTION FOR INFUSION	QOW

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
105298556	10529855	1	Gaucher's disease type I
105298556	10529855	2	Gaucher's disease type I

Outcome of event

Event ID	CASEID	OUTC COD
105298556	10529855	HO
105298556	10529855	OT

Reactions reported

Event ID	CASEID	PT
105298556	10529855	Back pain
105298556	10529855	Bradycardia
105298556	10529855	Cardiac failure congestive
105298556	10529855	Cardiac pacemaker insertion
105298556	10529855	Dyspnoea
105298556	10529855	Lung disorder
105298556	10529855	Plasma cell myeloma
105298556	10529855	Presyncope
105298556	10529855	Typhoid fever

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
105298556	10529855	1	19930823		0
105298556	10529855	2	20100105		0