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
126153622	12615362	2	F	20160422	20160905	20160802	20160912	EXP		IT-BRISTOL-MYERS SQUIBB COMPANY-BMS-2016-062272	BRISTOL MYERS SQUIBB		55.59	YR		M	Y	0.00000		20160912		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
126153622	12615362	1	PS	DAKLINZA	DACLATASVIR	1	Oral	60 MG, QD	10200	MG	206843	60	MG	FILM-COATED TABLET	QD
126153622	12615362	2	SS	SOVALDI	SOFOSBUVIR	1	Oral	400 MG, QD	68000	MG	0	400	MG		QD
126153622	12615362	3	SS	REBETOL	RIBAVIRIN	1	Oral	200 MG, UNK			0	200	MG

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126153622	12615362	1	Chronic hepatitis C
126153622	12615362	2	Chronic hepatitis C
126153622	12615362	3	Chronic hepatitis C

Outcome of event

Event ID	CASEID	OUTC COD
126153622	12615362	OT
126153622	12615362	DS

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
126153622	12615362		Hepatocellular carcinoma

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
126153622	12615362	1	20151105	20160422
126153622	12615362	2	20151105	20160422
126153622	12615362	3	20151105	20160422