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
117129752	11712975	2	F	20120627	20160825	20151108	20160826	EXP		MW-BRISTOL-MYERS SQUIBB COMPANY-17468729	BRISTOL MYERS SQUIBB		0.00	DY		F	Y	3.60000	KG	20160826		OT	MW	MW

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
117129752	11712975	1	PS	SUSTIVA	EFAVIRENZ	1	Transplacental	600 MG, QD	U	20972	600	MG	CAPSULE	QD
117129752	11712975	2	C	COMBIVIR	LAMIVUDINEIDOVUDINE	1	Transplacental	1 DF, QD	U	0	1	DF		QD
117129752	11712975	3	C	ALUVIA	LOPINAVIRRITONAVIR	1	Transplacental	1 DF, QD	U	0	1	DF		QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
117129752	11712975	1	Product used for unknown indication
117129752	11712975	2	Product used for unknown indication
117129752	11712975	3	Product used for unknown indication

Outcome of event

Event ID	CASEID	OUTC COD
117129752	11712975	CA
117129752	11712975	OT

Reactions reported

Event ID	CASEID	PT
117129752	11712975	Congenital acrochordon
117129752	11712975	Foetal exposure during pregnancy
117129752	11712975	Premature baby
117129752	11712975	Sepsis neonatal

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
117129752	11712975	1	20100222	20111114
117129752	11712975	2	20091123	20120627
117129752	11712975	3	20111114	20120627