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
125546281	12554628	1	I	201601	20160711	20160713	20160713	EXP		PHHY2016BR095912	NOVARTIS		79.72	YR		F	Y	57.00000	KG	20160713		MD	BR	BR

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	RECHAL	LOT NUM	EXP DT	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125546281	12554628	1	PS	ACLASTA	ZOLEDRONIC ACID	1	Intravenous (not otherwise specified)	5 MG, Q12MO							21817	5	MG	SOLUTION FOR INJECTION
125546281	12554628	2	SS	ACLASTA	ZOLEDRONIC ACID	1	Unknown	UNK							21817			SOLUTION FOR INJECTION

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125546281	12554628	1	Osteoporosis

Outcome of event

Reactions reported

Event ID	CASEID	PT
125546281	12554628	Cerebrovascular accident
125546281	12554628	Death
125546281	12554628	Device related infection
125546281	12554628	Syncope

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	DUR	DUR COD
125546281	12554628	1	2014		0
125546281	12554628	2	2015		0