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
114168292	11416829	2	F	20150709	20160719	20150825	20160725	EXP		IT-BRISTOL-MYERS SQUIBB COMPANY-BMS-2015-053724	BRISTOL MYERS SQUIBB		55.59	YR		M	Y	0.00000		20160725		CN	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
114168292	11416829	1	PS	DAKLINZA	DACLATASVIR	1	Unknown	60 MG, QD	180	MG	206843	60	MG	FILM-COATED TABLET	QD
114168292	11416829	2	SS	EPIVIR	LAMIVUDINE	1	Oral	300 MG, QD	900	MG	0	300	MG		QD
114168292	11416829	3	SS	SOVALDI	SOFOSBUVIR	1	Oral	400 MG, QD			0	400	MG	TABLET	QD
114168292	11416829	4	SS	ISENTRESS	RALTEGRAVIR POTASSIUM	1	Oral	400 MG, QD	1200	MG	0	400	MG	TABLET	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
114168292	11416829	1	Chronic hepatitis C
114168292	11416829	2	Asymptomatic HIV infection
114168292	11416829	3	Chronic hepatitis C
114168292	11416829	4	Asymptomatic HIV infection

Outcome of event

Event ID	CASEID	OUTC COD
114168292	11416829	OT
114168292	11416829	HO

Reactions reported

Event ID	CASEID	PT
114168292	11416829	Agitation
114168292	11416829	Insomnia
114168292	11416829	Neuralgia
114168292	11416829	Restlessness

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
114168292	11416829	1	20150707	20150718
114168292	11416829	2	20150707	20150718
114168292	11416829	3	20150707
114168292	11416829	4	20150707	20150718