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
125568071	12556807	1	I	201412	20160325	20160714	20160714	EXP		US-BAYER-2016-063197	BAYER		77.00	YR	E	F	Y	0.00000		20160714		CN	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	RECHAL	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125568071	12556807	1	SS	XARELTO	RIVAROXABAN	1	Oral	15 MG, UNK	Y	N	UNKNOWN	0	15	MG	FILM-COATED TABLET
125568071	12556807	2	SS	XARELTO	RIVAROXABAN	1			Y	N		0			FILM-COATED TABLET
125568071	12556807	3	SS	XARELTO	RIVAROXABAN	1			Y	N		0			FILM-COATED TABLET
125568071	12556807	4	SS	TICAGRELOR	TICAGRELOR	1		90 MG, BID				0	90	MG		BID
125568071	12556807	5	SS	TICAGRELOR	TICAGRELOR	1						0
125568071	12556807	6	SS	COUMADIN	WARFARIN SODIUM	1		UNK				0
125568071	12556807	7	PS	ACETYLSALICYLIC ACID({=100 mg)	ASPIRIN	1	Unknown	UNK	Y			999999			TABLET

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125568071	12556807	1	Thrombosis prophylaxis
125568071	12556807	2	Cerebrovascular accident prophylaxis
125568071	12556807	3	Atrial fibrillation
125568071	12556807	4	Coronary artery disease
125568071	12556807	5	Atrial fibrillation
125568071	12556807	6	Atrial fibrillation
125568071	12556807	7	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
125568071	12556807	HO

Reactions reported

Event ID	CASEID	PT
125568071	12556807	Acute kidney injury
125568071	12556807	Contusion
125568071	12556807	Epistaxis
125568071	12556807	Haemorrhagic erosive gastritis

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
125568071	12556807	1	20141204	20141215
125568071	12556807	4		20141216
125568071	12556807	6		201412
125568071	12556807	7		201412