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
113830373	11383037	3	F	20150709	20160722	20150814	20160801	EXP		IT-GILEAD-2015-0167174	GILEAD		55.00	YR	A	M	Y	0.00000		20160801		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	RECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
113830373	11383037	1	PS	SOVALDI	SOFOSBUVIR	1	Unknown	400 MG, QD	800	MG	U	204671	400	MG	TABLET	QD
113830373	11383037	2	SS	SOVALDI	SOFOSBUVIR	1	Oral	400 MG, QD	800	MG	U	204671	400	MG	TABLET	QD
113830373	11383037	3	SS	DAKLINZA	DACLATASVIR	1	Unknown	60 MG, QD	120	MG	U	0	60	MG		QD
113830373	11383037	4	SS	EPIVIR	LAMIVUDINE	1	Oral	300 MG, QD	600	MG	U	0	300	MG		QD
113830373	11383037	5	SS	ISENTRESS	RALTEGRAVIR POTASSIUM	1	Oral	400 MG, QID	3200	MG	U	0	400	MG		QID

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
113830373	11383037	1	Chronic hepatitis C
113830373	11383037	3	Chronic hepatitis C
113830373	11383037	4	Asymptomatic HIV infection
113830373	11383037	5	Asymptomatic HIV infection

Outcome of event

Event ID	CASEID	OUTC COD
113830373	11383037	HO

Reactions reported

Event ID	CASEID	PT
113830373	11383037	Agitation
113830373	11383037	Insomnia
113830373	11383037	Neuralgia

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
113830373	11383037	1	20150707	20150718
113830373	11383037	3	20150707	20150718
113830373	11383037	4	20150707	20150718
113830373	11383037	5	20150707	20150718