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
125637411	12563741	1	I	20160217	20160707	20160716	20160716	EXP		FR-BRISTOL-MYERS SQUIBB COMPANY-BMS-2016-056347	BRISTOL MYERS SQUIBB		51.96	YR		F	Y	0.00000		20160716		CN	FR	FR

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125637411	12563741	1	PS	REYATAZ	ATAZANAVIR SULFATE	1	Oral	300 MG, QD		21567	300	MG	CAPSULE, HARD	QD
125637411	12563741	2	SS	NORVIR	RITONAVIR	1	Oral	100 MG, QD		0	100	MG		QD
125637411	12563741	3	SS	DOCETAXEL.	DOCETAXEL	1	Intravenous (not otherwise specified)	100 MG/M2, UNK	U	0	100	MG/M**2

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125637411	12563741	1	HIV infection
125637411	12563741	2	HIV infection
125637411	12563741	3	Invasive ductal breast carcinoma

Outcome of event

Reactions reported

Event ID	CASEID	PT
125637411	12563741	Multiple organ dysfunction syndrome
125637411	12563741	Neutropenic colitis
125637411	12563741	Packed red blood cell transfusion
125637411	12563741	Pancytopenia
125637411	12563741	Septic shock
125637411	12563741	Stomatitis
125637411	12563741	Toxic skin eruption

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
125637411	12563741	1		20160305
125637411	12563741	2		20160305
125637411	12563741	3	20160212