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
122694392	12269439	2	F	20131205	20160901	20160414	20160906	EXP		PHHY2014DE023565	NOVARTIS		0.00		A	F	Y	53.00000	KG	20160906		OT	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	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
122694392	12269439	1	PS	AFINITOR	EVEROLIMUS	1	Oral	10 MG, QD	690	MG	Y	22334	10	MG	TABLET	QD
122694392	12269439	2	SS	AFINITOR	EVEROLIMUS	1	Oral	5 MG, QD	690	MG	Y	22334	5	MG	TABLET	QD
122694392	12269439	3	SS	EXEMESTAN ? 1 A PHARMA	EXEMESTANE	1	Oral	25 MG, QD	1725	MG	Y	0	25	MG		QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
122694392	12269439	1	Breast cancer metastatic
122694392	12269439	3	Breast cancer metastatic

Outcome of event

Reactions reported

Event ID	CASEID	PT
122694392	12269439	Anal fissure
122694392	12269439	Breast cancer metastatic
122694392	12269439	Diarrhoea
122694392	12269439	General physical health deterioration
122694392	12269439	Pleural effusion
122694392	12269439	Urinary tract infection

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
122694392	12269439	1	20131205	20140217
122694392	12269439	2	20140218	20140224
122694392	12269439	3	20131205	20140224