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
125382482	12538248	2	F	20160324	20160722	20160707	20160726	EXP		IT-GILEAD-2016-0222109	GILEAD		78.00	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	DOSE VBM	CUM DOSE CHR	CUM DOSE UNIT	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125382482	12538248	1	PS	SOVALDI	SOFOSBUVIR	1	Oral	400 MG, QD	33200	MG	204671	400	MG	TABLET	QD
125382482	12538248	2	SS	REBETOL	RIBAVIRIN	1	Oral	800 MG, QD	66400	MG	0	800	MG		QD
125382482	12538248	3	SS	OLYSIO	SIMEPREVIR	1	Oral	150 MG, QD	12450	MG	0	150	MG		QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125382482	12538248	1	Chronic hepatitis C
125382482	12538248	2	Chronic hepatitis C
125382482	12538248	3	Chronic hepatitis C

Outcome of event

Event ID	CASEID	OUTC COD
125382482	12538248	OT

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
125382482	12538248		Hepatic lesion
125382482	12538248		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
125382482	12538248	1	20150430	20150722
125382482	12538248	2	20150430	20150722
125382482	12538248	3	20150430	20150722