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
125516741	12551674	1	I	20141121	20160701	20160713	20160713	EXP		PHHY2016DE095598	NOVARTIS		0.00		E	M	Y	0.00000		20160713		MD	DE	DE

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	NDA NUM	DOSE AMT	DOSE UNIT
125516741	12551674	1	PS	TASIGNA	NILOTINIB	1	Oral	600 MG, PER DAY, UNK	Y	22068	600	MG
125516741	12551674	2	SS	TASIGNA	NILOTINIB	1	Oral	600 MG, PER DAY, UNK	Y	22068	600	MG
125516741	12551674	3	SS	TASIGNA	NILOTINIB	1	Oral	600 MG, PER DAY, UNK	Y	22068	600	MG
125516741	12551674	4	SS	TASIGNA	NILOTINIB	1	Oral	600 MG, PER DAY, UNK	Y	22068	600	MG
125516741	12551674	5	SS	TASIGNA	NILOTINIB	1	Oral	600 MG, PER DAY, UNK	Y	22068	600	MG
125516741	12551674	6	SS	TASIGNA	NILOTINIB	1	Oral	450 MG, PER DAY, UNK	Y	22068	450	MG
125516741	12551674	7	SS	TASIGNA	NILOTINIB	1	Oral	450 MG, PER DAY, UNK	Y	22068	450	MG
125516741	12551674	8	SS	TASIGNA	NILOTINIB	1	Oral	450 MG, PER DAY, UNK	Y	22068	450	MG
125516741	12551674	9	C	ASPIRIN.	ASPIRIN	1	Unknown	UNK		0
125516741	12551674	10	C	BRILIQUE	TICAGRELOR	1	Unknown	UNK		0
125516741	12551674	11	C	DELIX	RAMIPRIL	1	Unknown	UNK		0
125516741	12551674	12	C	HCT	HYDROCHLOROTHIAZIDE	1	Unknown	UNK		0
125516741	12551674	13	C	BELOC-ZOC MITE	METOPROLOL SUCCINATE	1	Unknown	UNK		0
125516741	12551674	14	C	METOPROLOL SUCCINATE.	METOPROLOL SUCCINATE	1	Unknown	UNK		0
125516741	12551674	15	C	L-THYROXIN	LEVOTHYROXINE SODIUM	1	Unknown	UNK		0

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125516741	12551674	1	Chronic myeloid leukaemia
125516741	12551674	9	Product used for unknown indication
125516741	12551674	10	Product used for unknown indication
125516741	12551674	11	Product used for unknown indication
125516741	12551674	12	Product used for unknown indication
125516741	12551674	13	Product used for unknown indication
125516741	12551674	14	Product used for unknown indication
125516741	12551674	15	Product used for unknown indication

Outcome of event

no results found

no results found

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
125516741	12551674		Chest pain

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
125516741	12551674	1	20130919
125516741	12551674	2	20131014
125516741	12551674	3	20131212
125516741	12551674	4	20140228
125516741	12551674	5	20140902
125516741	12551674	6	20141125
125516741	12551674	7	20150206
125516741	12551674	8	20150921
125516741	12551674	9	20140626
125516741	12551674	10	20140626
125516741	12551674	11	20140626
125516741	12551674	12	20140626
125516741	12551674	13	20140626
125516741	12551674	14	20140626
125516741	12551674	15	20140626