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
125760263	12576026	3	F	20150112	20160804	20160720	20160811	EXP		PHHY2016DE097396	NOVARTIS		0.00		A	M	Y	0.00000		20160811		MD	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	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FREQ
125760263	12576026	1	PS	TASIGNA	NILOTINIB	1	Oral	600 MG, QD (PER DAY)	100200	MG	22068	600	MG	QD
125760263	12576026	2	SS	TASIGNA	NILOTINIB	1	Oral	600 MG, QD	100200	MG	22068	600	MG	QD
125760263	12576026	3	SS	TASIGNA	NILOTINIB	1	Oral	600 MG, QD	100200	MG	22068	600	MG	QD
125760263	12576026	4	SS	TASIGNA	NILOTINIB	1	Oral	600 MG, QD	100200	MG	22068	600	MG	QD
125760263	12576026	5	SS	TASIGNA	NILOTINIB	1	Oral	300 MG, QD	100200	MG	22068	300	MG	QD
125760263	12576026	6	SS	TASIGNA	NILOTINIB	1	Oral	600 MG, QD	100200	MG	22068	600	MG	QD
125760263	12576026	7	SS	TASIGNA	NILOTINIB	1	Oral	600 MG, QD	100200	MG	22068	600	MG	QD
125760263	12576026	8	SS	TASIGNA	NILOTINIB	1	Oral	600 MG, QD	100200	MG	22068	600	MG	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125760263	12576026	1	Chronic myeloid leukaemia

Outcome of event

Event ID	CASEID	OUTC COD
125760263	12576026	HO
125760263	12576026	OT

Reactions reported

Event ID	CASEID	PT
125760263	12576026	Chronic obstructive pulmonary disease
125760263	12576026	Diarrhoea
125760263	12576026	Dyspnoea

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
125760263	12576026	1	20140325	20140423
125760263	12576026	2	20140514	20140612
125760263	12576026	3	20140709	20140807
125760263	12576026	4	20140813
125760263	12576026	5	20140901	20141008
125760263	12576026	6	20141216	20150211
125760263	12576026	7	20150526
125760263	12576026	8	20151102