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
127016312	12701631	2	F		20160831	20160831	20160905	EXP		CA-ROCHE-1822923	ROCHE		0.00			M	Y	0.00000		20160905		MD	CA	CA

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
127016312	12701631	1	PS	PEGASYS	PEGINTERFERON ALFA-2A	1	Oral	DOSE: 180 MICRO GRAM/0.5ML	U	103964			SOLUTION FOR INJECTION	QD
127016312	12701631	2	SS	RIBAVIRIN.	RIBAVIRIN	1	Unknown		U	21511
127016312	12701631	3	SS	SOVALDI	SOFOSBUVIR	1	Oral		U	0	400	MG	TABLET	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127016312	12701631	1	Hepatitis C
127016312	12701631	2	Hepatitis C
127016312	12701631	3	Hepatitis C

Outcome of event

Event ID	CASEID	OUTC COD
127016312	12701631	OT

Reactions reported

Event ID	CASEID	PT
127016312	12701631	Abdominal pain
127016312	12701631	Hepatic cirrhosis
127016312	12701631	Hepatitis C

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
127016312	12701631	1	20160212	20160506
127016312	12701631	2	20160212	20160506
127016312	12701631	3	20160212	20160506