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
124742953	12474295	3	F	20160229	20160824	20160617	20160902	EXP		NO-BRISTOL-MYERS SQUIBB COMPANY-BMS-2016-044754	BRISTOL MYERS SQUIBB		62.83	YR		M	Y	0.00000		20160902		MD	NO	NO

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
124742953	12474295	1	PS	DAKLINZA	DACLATASVIR	1	Unknown	60 MG, QD	206843	60	MG	FILM-COATED TABLET	QD
124742953	12474295	2	SS	SOFOSBUVIR	SOFOSBUVIR	1	Unknown	400 MG, QD	0	400	MG		QD
124742953	12474295	3	SS	REBETOL	RIBAVIRIN	1	Unknown	200 MG, BID	0	200	MG		BID
124742953	12474295	4	SS	REBETOL	RIBAVIRIN	1	Unknown	600 MG, UNK	0	600	MG

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
124742953	12474295	1	Hepatitis C
124742953	12474295	2	Hepatitis C
124742953	12474295	3	Hepatitis C

Outcome of event

Event ID	CASEID	OUTC COD
124742953	12474295	OT
124742953	12474295	HO

Reactions reported

Event ID	CASEID	PT
124742953	12474295	Cerebellar haemorrhage
124742953	12474295	Cerebral haemorrhage
124742953	12474295	Hepatectomy
124742953	12474295	Hepatic failure

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
124742953	12474295	1	20160116
124742953	12474295	2	20160116
124742953	12474295	3	20160116
124742953	12474295	4	20160116