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
125832642	12583264	2	F	201206	20160925	20160722	20160930	EXP		PHHY2016DE071136	NOVARTIS		0.00		E	M	Y	0.00000		20160930		CN	DE	DE

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
125832642	12583264	1	PS	TASIGNA	NILOTINIB	1	Oral	200 MG, BID			Y				22068	200	MG	CAPSULE	BID
125832642	12583264	2	SS	TASIGNA	NILOTINIB	1	Oral	200 MG, BID			Y				22068	200	MG	CAPSULE	BID

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125832642	12583264	1	Chronic myeloid leukaemia

Outcome of event

Event ID	CASEID	OUTC COD
125832642	12583264	OT
125832642	12583264	HO

Reactions reported

Event ID	CASEID	PT
125832642	12583264	Angina pectoris
125832642	12583264	Burns second degree
125832642	12583264	Cardiac failure
125832642	12583264	Chest pain
125832642	12583264	Dyspnoea
125832642	12583264	Fatigue
125832642	12583264	Pain
125832642	12583264	Skin lesion

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
125832642	12583264	1	201106	20121025	0
125832642	12583264	2	20121028	201309	0