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
111821542	11182154	2	F	201502	20160607	20150611	20160915	PER		US-ASTELLAS-2015US010948	ASTELLAS		61.48	YR		M	Y	0.00000		20160915		CN	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
111821542	11182154	1	PS	XTANDI	ENZALUTAMIDE	1	Oral		U	1526650PC	203415	160	MG	CAPSULE	QD
111821542	11182154	2	SS	XTANDI	ENZALUTAMIDE	1	Unknown	UNK, UNKNOWN FREQ.	U		203415			CAPSULE
111821542	11182154	3	SS	LUPRON	LEUPROLIDE ACETATE	1	Unknown	UNK, UNKNOWN FREQ.	U		0			FORMULATION UNKNOWN

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
111821542	11182154	1	Prostate cancer
111821542	11182154	2	Hormone-refractory prostate cancer
111821542	11182154	3	Product used for unknown indication

Outcome of event

no results found

no results found

Reactions reported

Event ID	CASEID	PT
111821542	11182154	Anxiety
111821542	11182154	Arthralgia
111821542	11182154	Arthritis
111821542	11182154	Asthenia
111821542	11182154	Clumsiness
111821542	11182154	Contusion
111821542	11182154	Dyspnoea
111821542	11182154	Fall
111821542	11182154	Fatigue
111821542	11182154	Hot flush
111821542	11182154	Insomnia
111821542	11182154	Memory impairment
111821542	11182154	Muscle spasms
111821542	11182154	Temperature intolerance
111821542	11182154	Weight increased

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
111821542	11182154	1	201403		0
111821542	11182154	2	20150213		0