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
125121472	12512147	2	F	201312	20160908	20160630	20160921	PER		US-JNJFOC-20160516607	JANSSEN		54.28	YR	A	F	Y	0.00000		20160921		CN	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DECHAL	RECHAL	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125121472	12512147	1	SS	XARELTO	RIVAROXABAN	1	Oral	Y	U	UNKNOWN	0	20	MG	TABLET	QD
125121472	12512147	2	SS	XARELTO	RIVAROXABAN	1	Oral	Y	U	UNKNOWN	0	20	MG	TABLET	QD
125121472	12512147	3	SS	XARELTO	RIVAROXABAN	1	Oral	Y	U	UNKNOWN	0	20	MG	TABLET	QD
125121472	12512147	4	SS	XARELTO	RIVAROXABAN	1	Oral	Y	U	UNKNOWN	0	20	MG	TABLET	QD
125121472	12512147	5	SS	XARELTO	RIVAROXABAN	1	Oral	Y	U	UNKNOWN	0	20	MG	TABLET	QD
125121472	12512147	6	SS	XARELTO	RIVAROXABAN	1	Oral	Y	U	UNKNOWN	0	20	MG	TABLET	QD
125121472	12512147	7	SS	XARELTO	RIVAROXABAN	1	Oral	Y	U	UNKNOWN	0	20	MG	TABLET	QD
125121472	12512147	8	PS	XARELTO	RIVAROXABAN	1	Oral	Y	U	UNKNOWN	202439	20	MG	TABLET	QD
125121472	12512147	9	SS	ASPIRIN.	ASPIRIN	1	Oral				0	81	MG	ENCAPSULATED TABLET	QD
125121472	12512147	10	SS	PLAVIX	CLOPIDOGREL BISULFATE	1	Oral				0	75	MG	TABLETS	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125121472	12512147	1	Cerebrovascular accident prophylaxis
125121472	12512147	2	Cerebrovascular accident prophylaxis
125121472	12512147	3	Atrial fibrillation
125121472	12512147	4	Atrial fibrillation
125121472	12512147	5	Pulmonary embolism
125121472	12512147	6	Pulmonary embolism
125121472	12512147	7	Deep vein thrombosis
125121472	12512147	8	Deep vein thrombosis
125121472	12512147	9	Product used for unknown indication
125121472	12512147	10	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
125121472	12512147	HO
125121472	12512147	OT

Reactions reported

Event ID	CASEID	PT
125121472	12512147	Coagulopathy
125121472	12512147	Gastrointestinal haemorrhage
125121472	12512147	Haematoma
125121472	12512147	Post procedural haemorrhage

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
125121472	12512147	1	20130726	201312
125121472	12512147	2	2013	20140523
125121472	12512147	3	20130726	201312
125121472	12512147	4	2013	20140523
125121472	12512147	5	2013	20140523
125121472	12512147	6	20130726	201312
125121472	12512147	7	20130726	201312
125121472	12512147	8	2013	20140523