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
125285313	12528531	3	F	201605	20160913	20160705	20160920	EXP		US-BAYER-2016-103983	BAYER		45.00	YR	A	M	Y	0.00000		20160920		MD	US	US

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	RECHAL	LOT NUM	EXP DT	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125285313	12528531	1	PS	NEXAVAR	SORAFENIB	1	Oral	400 MG, BID							21923	400	MG	FILM-COATED TABLET	BID
125285313	12528531	2	SS	NEXAVAR	SORAFENIB	1		200 MG, BID							21923	200	MG	FILM-COATED TABLET	BID

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125285313	12528531	1	Hepatocellular carcinoma
125285313	12528531	2	Hepatocellular carcinoma

Outcome of event

Event ID	CASEID	OUTC COD
125285313	12528531	OT

Reactions reported

Event ID	CASEID	PT
125285313	12528531	Abasia
125285313	12528531	Hepatocellular carcinoma
125285313	12528531	Pain in extremity
125285313	12528531	Skin exfoliation

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	DUR	DUR COD
125285313	12528531	1	20160506	20160617	0
125285313	12528531	2	20160621	20160718	0