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
125978851	12597885	1	I	20160412	20160721	20160726	20160726	EXP		IT-GILEAD-2016-0224858	GILEAD		55.00	YR	A	F	Y	0.00000		20160726		PH	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
125978851	12597885	1	PS	SOVALDI	SOFOSBUVIR	1	Oral	400 MG, QD	64000	MG	204671	400	MG	TABLET	QD
125978851	12597885	2	SS	DAKLINZA	DACLATASVIR	1	Oral	60 MG, QD	9600	MG	0	60	MG		QD
125978851	12597885	3	SS	COPEGUS	RIBAVIRIN	1	Oral	800 MG, UNK			0	800	MG
125978851	12597885	4	C	XANAX	ALPRAZOLAM	1	Oral	0.25 MG, UNK			0	.25	MG

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125978851	12597885	1	Hepatitis C
125978851	12597885	2	Hepatitis C
125978851	12597885	3	Hepatitis C
125978851	12597885	4	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
125978851	12597885	OT

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
125978851	12597885		Drug ineffective
125978851	12597885		Hepatitis C RNA increased

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
125978851	12597885	1	20150924	20160302
125978851	12597885	2	20150924	20160302
125978851	12597885	3	20150924	20160302