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
127666172	12766617	2	F	201503	20160919	20160921	20160922	EXP		SE-JNJFOC-20160920616	JANSSEN		62.00	YR	A	M	Y	0.00000		20160922		MD	SE	SE

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
127666172	12766617	1	PS	OLYSIO	SIMEPREVIR	1	Oral	N	205123	150	MG	CAPSULE	QD
127666172	12766617	2	SS	COPEGUS	RIBAVIRIN	1	Oral		0	600	MG	TABLET	BID
127666172	12766617	3	SS	SOVALDI	SOFOSBUVIR	1	Oral		0	400	MG	TABLET	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127666172	12766617	1	Product used for unknown indication
127666172	12766617	2	Product used for unknown indication
127666172	12766617	3	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
127666172	12766617	DE

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
127666172	12766617		Hepatic failure
127666172	12766617		Jaundice

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
127666172	12766617	1	20150204	20150325
127666172	12766617	2	20150204	20150325
127666172	12766617	3	20150204	20150325