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
126063361	12606336	1	I	20160323	20160722	20160729	20160729	EXP		JP-ROCHE-1805224	ROCHE		70.00	YR		M	Y	0.00000		20160729		MD	JP	JP

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	DECHAL	RECHAL	LOT NUM	EXP DT	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
126063361	12606336	1	PS	COPEGUS	RIBAVIRIN	1	Oral	THE FRACTIONATION DOSE FREQUENCY IS UNCERTAIN. ?DOSE INTERVAL UNCERTAINTY							21511	600	MG	TABLET
126063361	12606336	2	SS	SOVALDI	SOFOSBUVIR	1	Oral	THE FRACTIONATION DOSE FREQUENCY IS UNCERTAIN. ?DOSE INTERVAL UNCERTAINTY							0	400	MG	TABLET

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126063361	12606336	1	Hepatic cirrhosis
126063361	12606336	2	Hepatic cirrhosis

Outcome of event

Event ID	CASEID	OUTC COD
126063361	12606336	OT

Reactions reported

Event ID	CASEID	PT
126063361	12606336	Drug ineffective
126063361	12606336	Hepatitis C
126063361	12606336	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	DUR	DUR COD
126063361	12606336	1	20151202	20160223	0
126063361	12606336	2	20151202	20160223	0