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
124260026	12426002	6	F	20160413	20160902	20160601	20160912	EXP		TR-TAKEDA-2016MPI004882	TAKEDA		61.79	YR		M	Y	85.00000	KG	20160912		MD	TR	TR

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
124260026	12426002	1	PS	VELCADE	BORTEZOMIB	1	Intravenous (not otherwise specified)	1.3 MG/M2, UNK			Y				21602	1.3	MG/M**2	INJECTION
124260026	12426002	2	SS	DEXAMETHASONE.	DEXAMETHASONE	1	Oral	20 MG, UNK			Y				0	20	MG

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
124260026	12426002	1	Plasma cell myeloma
124260026	12426002	2	Plasma cell myeloma

Outcome of event

Event ID	CASEID	OUTC COD
124260026	12426002	OT
124260026	12426002	HO

Reactions reported

Event ID	CASEID	PT
124260026	12426002	Abdominal pain
124260026	12426002	Drug ineffective
124260026	12426002	Hyperviscosity syndrome
124260026	12426002	Plasmacytoma
124260026	12426002	Respiratory distress

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
124260026	12426002	1	20160216	20160408	0
124260026	12426002	2	20160216	20160408	0