Safety Rates Drug Report: adverse events in 2009 Q2 - FDA prescription drugs adverse events in an open, searchable, online, public database

Drug Injury Quarter

Person who experienced the adverse event (patient)

Event ID	CASE	I F COD	FOLL SEQ	IMAGE	EVENT DT	MFR DT	FDA DT	REPT COD	MFR NUM	MFR SNDR	AGE	AGE COD	GNDR COD	E SUB	WT	WT COD	REPT DT	OCCP COD	DEATH DT	TO MFR	CONFID	REPORTER COUNTRY
6255536	7048354	F	2	6255536-8	20090323	20090622	20090630	EXP	2009JP002026	ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.	71	YR	M	N	56.9	KG	20090626	MD	20090408			JAPAN

Drug(s) used by person

Event ID	DRUG SEQ	ROLE COD	DRUGNAME	VAL VBM	ROUTE	DOSE VBM	DECHAL	RECHAL	NDA NUM
6255536	1011834556	PS	SOLIFENACIN BLINDED(CODE NOT BROKEN) TABLET, UNKNOWN	2	ORAL	2 DF, UID/QD, ORAL	D	D	21518
6255536	1011875698	SS	TAMSULOSIN HCL	1	ORAL	0.2 MG,/D, ORAL	D	D
6255536	1011875699	C	NSAID'S PER ORAL NOS	2
6255536	1011875700	C	LORCAM (LORNOXICAM) TABLET	2
6255536	1011875740	C	METHYCOBAL (MECOBALAMIN) TABLET	2
6255536	1011875746	C	AZULENE (AZULENE) FINE GRANULE	2
6255536	1011875747	C	PREDNISOLONE TAB	1
6255536	1011875748	C	CARBOCAIN (MEPIVACAINE HYDROCHLORIDE) INJECTION, 1 %	2

Indications of drugs used

Event ID	DRUG SEQ	INDI PT
6255536	1011834556	HYPERTONIC BLADDER
6255536	1011875698	BENIGN PROSTATIC HYPERPLASIA

Outcome of event

Event ID	OUTC COD
6255536	DE
6255536	OT

Reactions reported

Event ID	PT
6255536	ACUTE LEUKAEMIA
6255536	BACK PAIN
6255536	GAIT DISTURBANCE
6255536	INTERVERTEBRAL DISC PROTRUSION
6255536	PAIN IN EXTREMITY
6255536	SHOCK

Reporting Sources (this data is often not reported and may therefore be missing here)

Therapies reported

Event ID	DRUG SEQ	START DT	END DT	DUR	DUR COD
6255536	1011834556	20090108	20090401
6255536	1011875698	20081022	20090401