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
113745592	11374559	2	F	20150709	20160719	20150813	20160726	EXP		IT-009507513-1508ITA004516	MERCK		55.00	YR		M	Y	0.00000		20160726		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
113745592	11374559	1	PS	ISENTRESS	RALTEGRAVIR POTASSIUM	1	Oral	400 MG, QD	1200	MG	U	22145	400	MG	TABLET	QD
113745592	11374559	2	SS	EPIVIR	LAMIVUDINE	1	Oral	300 MG, QD	900	MG	U	0	300	MG	TABLET	QD
113745592	11374559	3	SS	DAKLINZA	DACLATASVIR	1		60 MG, QD	180	MG	U	0	60	MG	TABLET	QD
113745592	11374559	4	SS	SOVALDI	SOFOSBUVIR	1		400 MG, QD	1200	MG	U	0	400	MG	TABLET	QD
113745592	11374559	5	SS	SOVALDI	SOFOSBUVIR	1		400 MG, QD	1200	MG	U	0	400	MG	TABLET	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
113745592	11374559	1	Asymptomatic HIV infection
113745592	11374559	2	Asymptomatic HIV infection
113745592	11374559	3	Chronic hepatitis C
113745592	11374559	4	Chronic hepatitis C

Outcome of event

Event ID	CASEID	OUTC COD
113745592	11374559	HO

Reactions reported

Event ID	CASEID	PT
113745592	11374559	Insomnia
113745592	11374559	Neuralgia
113745592	11374559	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
113745592	11374559	1	20150707	20150718
113745592	11374559	2	20150707	20150718
113745592	11374559	3	20150707	20150718
113745592	11374559	4	20150707	20150718
113745592	11374559	5	2015