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
127096502	12709650	2	F	20160808	20160902	20160902	20160908	EXP		CA-JNJFOC-20160827572	JANSSEN		50.93	YR	A	F	Y	74.84000	KG	20160908		CN	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
127096502	12709650	1	SS	STELARA	USTEKINUMAB	1	Subcutaneous				Y	U			0			SOLUTION FOR INJECTION
127096502	12709650	2	PS	STELARA	USTEKINUMAB	1	Subcutaneous				Y	U			125261	90	MG	SOLUTION FOR INJECTION

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127096502	12709650	1	Crohn's disease
127096502	12709650	2	Crohn's disease

Outcome of event

Event ID	CASEID	OUTC COD
127096502	12709650	OT

Reactions reported

Event ID	CASEID	PT
127096502	12709650	Abdominal pain upper
127096502	12709650	Fatigue
127096502	12709650	Nasopharyngitis
127096502	12709650	Oropharyngeal pain
127096502	12709650	Pain in extremity
127096502	12709650	Tooth abscess

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
127096502	12709650	1	20140325		0