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
117916072	11791607	2	F	20150707	20160825	20151201	20160826	EXP		FR-BRISTOL-MYERS SQUIBB COMPANY-BMS-2015-080272	BRISTOL MYERS SQUIBB		72.40	YR		F	Y	0.00000		20160826		CN	FR	FR

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
117916072	11791607	1	PS	SPRYCEL	DASATINIB	1	Oral	70 MG, QD	910	MG		21986	70	MG	FILM-COATED TABLET	QD
117916072	11791607	2	SS	GLIVEC	IMATINIB MESYLATE	1	Oral	400 MG, UNK				0	400	MG
117916072	11791607	3	C	LEVOTHYROX	LEVOTHYROXINE	1	Unknown	100 ?G, UNK			U	0	100	UG
117916072	11791607	4	C	STILNOX	ZOLPIDEM TARTRATE	1	Unknown	10 MG, UNK			U	0	10	MG
117916072	11791607	5	C	ASPEGIC	ASPIRIN DL-LYSINE	1	Unknown	100 MG, UNK			U	0	100	MG

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
117916072	11791607	1	Chronic myeloid leukaemia
117916072	11791607	2	Chronic myeloid leukaemia
117916072	11791607	3	Product used for unknown indication
117916072	11791607	4	Product used for unknown indication
117916072	11791607	5	Product used for unknown indication

Outcome of event

Reactions reported

Event ID	CASEID	PT
117916072	11791607	Breast cancer
117916072	11791607	Pleural effusion
117916072	11791607	Prescribed underdose

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
117916072	11791607	1	20150625	20150715
117916072	11791607	2	201306	20150625
117916072	11791607	5	201501