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
125340372	12534037	2	F	20160628	20160706	20160706	20160711	EXP		PL-GILEAD-2016-0221634	GILEAD		56.00	YR	A	F	Y	61.00000	KG	20160711		MD	PL	PL

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125340372	12534037	1	PS	SOVALDI	SOFOSBUVIR	1	Oral	400 MG, UNK		204671	400	MG	TABLET
125340372	12534037	2	SS	RIBAVIRIN.	RIBAVIRIN	1	Oral	1000 MG, QD	Y	0	1000	MG		QD
125340372	12534037	3	SS	RIBAVIRIN.	RIBAVIRIN	1	Oral	400 MG, QD	Y	0	400	MG		QD
125340372	12534037	4	SS	RIBAVIRIN.	RIBAVIRIN	1	Oral	600 MG, QD	Y	0	600	MG		QD
125340372	12534037	5	SS	RIBAVIRIN.	RIBAVIRIN	1	Oral	800 MG, QD	Y	0	800	MG		QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125340372	12534037	1	Hepatitis C
125340372	12534037	2	Hepatitis C

Outcome of event

Event ID	CASEID	OUTC COD
125340372	12534037	HO

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
125340372	12534037		Anaemia
125340372	12534037		Malaise

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
125340372	12534037	1	20160603		0
125340372	12534037	2	20160603		0