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
106398625	10639862	5	F	20141027	20160815	20141209	20160819	EXP		PHHY2014CA157111	NOVARTIS		55.75	YR		M	Y	0.00000		20160819		MD	CA	CA

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
106398625	10639862	1	PS	EXJADE	DEFERASIROX	1	Oral	3000 MG, QD	21882	3000	MG	DISPERSIBLE TABLET	QD
106398625	10639862	2	SS	EXJADE	DEFERASIROX	1	Oral	3000 MG, QD	21882	3000	MG	DISPERSIBLE TABLET	QD
106398625	10639862	3	SS	EXJADE	DEFERASIROX	1	Oral	2000 MG, QD	21882	2000	MG	DISPERSIBLE TABLET	QD
106398625	10639862	4	SS	EXJADE	DEFERASIROX	1	Oral	1000 MG, QD	21882	1000	MG	DISPERSIBLE TABLET	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
106398625	10639862	1	Refractory anaemia with ringed sideroblasts

Outcome of event

Event ID	CASEID	OUTC COD
106398625	10639862	HO

Reactions reported

Event ID	CASEID	PT
106398625	10639862	Fatigue
106398625	10639862	Feeling abnormal
106398625	10639862	Malaise

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
106398625	10639862	1	20140914		0
106398625	10639862	4		20160630	0