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
125508711	12550871	1	I	20160505	20160523	20160712	20160712	EXP		US-UCBSA-2016019358	UCB		51.90	YR		F	Y	0.00000		20160713		PH	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
125508711	12550871	1	PS	CIMZIA	CERTOLIZUMAB PEGOL	1	Subcutaneous	400 MG, EV 4 WEEKS			U	U			125160	400	MG	SOLUTION FOR INJECTION
125508711	12550871	2	SS	CIMZIA	CERTOLIZUMAB PEGOL	1	Subcutaneous	400 MG, EV 2 WEEKS(QOW)			U	U			125160	400	MG	SOLUTION FOR INJECTION	QOW

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125508711	12550871	1	Crohn's disease

Outcome of event

Event ID	CASEID	OUTC COD
125508711	12550871	OT

Reactions reported

Event ID	CASEID	PT
125508711	12550871	Arthralgia
125508711	12550871	Fatigue
125508711	12550871	Haematochezia
125508711	12550871	Myalgia
125508711	12550871	Pharyngitis streptococcal

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
125508711	12550871	1	20150219		0
125508711	12550871	2	20160331		0