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
125290462	12529046	2	F	20150930	20160722	20160705	20160726	EXP		IT-JNJFOC-20160701551	JANSSEN		69.34	YR	E	M	Y	71.00000	KG	20160726		MD	IT	IT

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	RECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM
125290462	12529046	1	PS	OLYSIO	SIMEPREVIR	1	Oral	N	205123	150	MG	CAPSULE
125290462	12529046	2	SS	SOVALDI	SOFOSBUVIR	1	Oral		0	400	MG	FILM COATED TABLET
125290462	12529046	3	SS	REBETOL	RIBAVIRIN	1	Oral		0	1000	MG	CAPSULE, HARD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125290462	12529046	1	Chronic hepatitis C
125290462	12529046	2	Chronic hepatitis C
125290462	12529046	3	Chronic hepatitis C

Outcome of event

Event ID	CASEID	OUTC COD
125290462	12529046	OT

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
125290462	12529046		Hepatic lesion
125290462	12529046		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
125290462	12529046	1	20150527	20150819
125290462	12529046	2	20150527	20150819
125290462	12529046	3	20150527	20150819