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
123531763	12353176	3	F	20160310	20160721	20160510	20160727	EXP		IT-BRISTOL-MYERS SQUIBB COMPANY-BMS-2016-034793	BRISTOL MYERS SQUIBB		55.82	YR		F	Y	0.00000		20160727		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	DECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
123531763	12353176	1	PS	DAKLINZA	DACLATASVIR	1	Oral	60 MG, QD	9660	MG		206843	60	MG	FILM-COATED TABLET	QD
123531763	12353176	2	SS	SOVALDI	SOFOSBUVIR	1	Oral	400 MG, QD	64400	MG		0	400	MG		QD
123531763	12353176	3	SS	COPEGUS	RIBAVIRIN	1	Oral	800 MG, UNK				0	800	MG	TABLET
123531763	12353176	4	C	XANAX	ALPRAZOLAM	1	Oral	0.25 MG, UNK			U	0	.25	MG	TABLET

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
123531763	12353176	1	Hepatitis C
123531763	12353176	2	Hepatitis C
123531763	12353176	3	Hepatitis C
123531763	12353176	4	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
123531763	12353176	OT

Reactions reported

Event ID	CASEID	PT
123531763	12353176	Adrenal neoplasm
123531763	12353176	Hepatitis C
123531763	12353176	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
123531763	12353176	1	20150924	20160302
123531763	12353176	2	20150924	20160302
123531763	12353176	3	20150924	20160302
123531763	12353176	4	20150924