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
125027292	12502729	2	F	20160604	20160827	20160628	20160902	EXP		JP-ROCHE-1782415	ROCHE		29.00	YR		F	Y	44.00000	KG	20160902		MD	JP	JP

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	CUM DOSE CHR	CUM DOSE UNIT	DECHAL	RECHAL	LOT NUM	EXP DT	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125027292	12502729	1	PS	COPEGUS	RIBAVIRIN	1	Oral	DOSAGE IS UNCERTAIN.?DISCONTINUED AT A DOSE OF AT 200 MG							21511			TABLET	BID
125027292	12502729	2	SS	SOVALDI	SOFOSBUVIR	1	Oral	FRACTIONATION DOSE UNCERTAIN FREQUENCY AND DOSE INTERVAL UNCERTAINTY							0	400	MG	TABLET

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125027292	12502729	1	Chronic hepatitis C
125027292	12502729	2	Chronic hepatitis C

Outcome of event

Event ID	CASEID	OUTC COD
125027292	12502729	OT

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
125027292	12502729		Abortion spontaneous
125027292	12502729		Maternal exposure during pregnancy

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
125027292	12502729	1	20160517	20160530	0
125027292	12502729	2	20160517	20160530	0