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
125369342	12536934	2	F	20160324	20160722	20160707	20160726	EXP		IT-JNJFOC-20160702881	JANSSEN		77.96	YR	E	M	Y	56.00000	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	DOSE FREQ
125369342	12536934	1	PS	OLYSIO	SIMEPREVIR	1	Oral	N	205123	150	MG	CAPSULE	QD
125369342	12536934	2	SS	SOVALDI	SOFOSBUVIR	1	Oral		0	400	MG	FILM COATED TABLET	QD
125369342	12536934	3	SS	REBETOL	RIBAVIRIN	1	Oral		0	800	MG	CAPSULE, HARD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125369342	12536934	1	Chronic hepatitis C
125369342	12536934	2	Chronic hepatitis C
125369342	12536934	3	Chronic hepatitis C

Outcome of event

Event ID	CASEID	OUTC COD
125369342	12536934	OT

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
125369342	12536934		Hepatocellular carcinoma
125369342	12536934		Liver injury

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
125369342	12536934	1	20150430	20150722
125369342	12536934	2	20150430	20150722
125369342	12536934	3	20150430	20150722