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
123234603	12323460	3	F	20160306	20160714	20160502	20160719	EXP		CA-JNJFOC-20160427674	JANSSEN		18.82	YR	T	M	Y	0.00000		20160719		OT	CA	CA

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
123234603	12323460	1	SS	STELARA	USTEKINUMAB	1	Subcutaneous				N	N	FKS06MA		0	90	MG	SOLUTION FOR INJECTION
123234603	12323460	2	PS	STELARA	USTEKINUMAB	1	Subcutaneous				N	N	FKS06MA		125261	90	MG	SOLUTION FOR INJECTION

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
123234603	12323460	1	Crohn's disease
123234603	12323460	2	Crohn's disease

Outcome of event

Event ID	CASEID	OUTC COD
123234603	12323460	OT

Reactions reported

Event ID	CASEID	PT
123234603	12323460	Crohn's disease
123234603	12323460	Drug ineffective for unapproved indication
123234603	12323460	Off label use

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
123234603	12323460	1	20160306		0
123234603	12323460	2	20160428	20160627	0