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
125382392	12538239	2	F	20150625	20160721	20160707	20160728	EXP		IT-GILEAD-2016-0221463	GILEAD		56.00	YR	A	M	Y	65.00000	KG	20160728		MD	IT	IT

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	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125382392	12538239	1	PS	SOVALDI	SOFOSBUVIR	1	Oral	400 MG, QD	10800	MG	204671	400	MG	TABLET	QD
125382392	12538239	2	SS	DAKLINZA	DACLATASVIR	1	Oral	60 MG, QD	1620	MG	0	60	MG		QD
125382392	12538239	3	SS	REBETOL	RIBAVIRIN	1	Oral	1000 MG, QD	27000	MG	0	1000	MG		QD
125382392	12538239	4	C	ESKIM	OMEGA-3 FATTY ACIDS	1	Oral	3000 MG, UNK			0	3000	MG

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125382392	12538239	1	Chronic hepatitis C
125382392	12538239	2	Chronic hepatitis C
125382392	12538239	3	Chronic hepatitis C

Outcome of event

Event ID	CASEID	OUTC COD
125382392	12538239	OT

Reactions reported

Event ID	CASEID	PT
125382392	12538239	Hepatic cancer
125382392	12538239	Hepatic lesion
125382392	12538239	Hepatocellular carcinoma

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
125382392	12538239	1	20150529	20151112
125382392	12538239	2	20150529	20151112
125382392	12538239	3	20150529	20151112
125382392	12538239	4	20140701