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
125839762	12583976	2	F	20150101	20160915	20160722	20160919	EXP		PHHY2015EC050733	NOVARTIS		43.84	YR		M	Y	0.00000		20160919		CN	COUNTRY NOT SPECIFIED	EC

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	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125839762	12583976	1	PS	TASIGNA	NILOTINIB	1	Oral	400 MG, BID	319800	MG	D	22068	400	MG	CAPSULE	BID
125839762	12583976	2	SS	TASIGNA	NILOTINIB	1	Oral	200 MG, QD	319800	MG	D	22068	200	MG	CAPSULE	QD
125839762	12583976	3	SS	TASIGNA	NILOTINIB	1	Oral	200 MG, Q48H	319800	MG	D	22068	200	MG	CAPSULE
125839762	12583976	4	SS	TASIGNA	NILOTINIB	1	Oral	200 MG, QD	319800	MG	D	22068	200	MG	CAPSULE	QD
125839762	12583976	5	SS	TASIGNA	NILOTINIB	1	Oral	200 MG, BID	319800	MG	D	22068	200	MG	CAPSULE	BID
125839762	12583976	6	SS	TASIGNA	NILOTINIB	1	Oral	400 MG, BID	319800	MG	D	22068	400	MG	CAPSULE	BID
125839762	12583976	7	SS	TASIGNA	NILOTINIB	1	Oral	200 MG, TID	319800	MG	D	22068	200	MG	CAPSULE	TID
125839762	12583976	8	SS	TASIGNA	NILOTINIB	1	Oral	400 MG, BID	319800	MG	D	22068	400	MG	CAPSULE	BID

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125839762	12583976	1	Chronic myeloid leukaemia

Outcome of event

no results found

no results found

Reactions reported

Event ID	CASEID	PT
125839762	12583976	Arthralgia
125839762	12583976	Back pain
125839762	12583976	Chest pain
125839762	12583976	Headache
125839762	12583976	Hyperhidrosis
125839762	12583976	Incorrect drug administration duration
125839762	12583976	Influenza
125839762	12583976	Oropharyngeal pain
125839762	12583976	Pain
125839762	12583976	Pyrexia
125839762	12583976	Urinary tract disorder

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
125839762	12583976	1	20141030	20150708
125839762	12583976	2	20150709	20150807
125839762	12583976	3	20150909	20160211
125839762	12583976	4	20160212	20160512
125839762	12583976	5	20160513	20160608
125839762	12583976	6	20160609	20160707
125839762	12583976	7	20160708	20160807
125839762	12583976	8	20160808	20160910