Safety Rates Drug Report: adverse events in 2005 Q4 - 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
4757724	6030984	I		4757724-6	20050621	20050822	20050830	EXP	STA-AE-05-MTX-017	STADA PHARMACEUTICALS, INC.	57	YR	F	N			20050824	OT				SOUTH AFRICA

Drug(s) used by person

Event ID	DRUG SEQ	ROLE COD	DRUGNAME	VAL VBM	ROUTE	DOSE VBM	DECHAL	RECHAL	NDA NUM
4757724	1006376685	PS	METHOTREXATE SODIUM	1	ORAL	15 MG - ORAL	D	D	8085
4757724	1006394461	SS	ABATACEPT	2	INTRAVENOUS	IV	D	D
4757724	1006394463	SS	INFLIXIMAB	2	INTRAVENOUS	IV
4757724	1006394466	SS	PLACEBO	2	INTRAVENOUS	IV
4757724	1006394467	C	PREDNISONE	1
4757724	1006394469	C	FOLIC ACID	1
4757724	1006394470	C	VELTEX (DICLOFENAC SODIUM)	2

Indications of drugs used

Outcome of event

Event ID	OUTC COD
4757724	HO

Reactions reported

Event ID	PT
4757724	ABSCESS SOFT TISSUE

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

Therapies reported

Event ID	DRUG SEQ	START DT
4757724	1006376685	20041203
4757724	1006394461	20050511
4757724	1006394463	20050511
4757724	1006394466	20050511