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
125762074	12576207	4	F		20160830	20160720	20160906	EXP		ES-JNJFOC-20160714265	JANSSEN		47.00	YR	A	M	Y	100.00000	KG	20160906		OT	ES	ES

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	RECHAL	LOT NUM	NDA NUM	DOSE FORM
125762074	12576207	1	PS	OLYSIO	SIMEPREVIR	1	Unknown	COMPLETED 12 WEEK THERAPY, ??TREATED FOR 84 DAYS	N	UNKNOWN;UNKNOWN	205123	CAPSULE
125762074	12576207	2	SS	SOVALDI	SOFOSBUVIR	1	Unknown	COMPLETED 12 WEEK THERAPY??TREATED FOR 84 DAYS			0	UNSPECIFIED
125762074	12576207	3	SS	RIBAVIRIN.	RIBAVIRIN	1	Unknown	COMPLETED 12 WEEK THERAPY,??TREATED FOR 84 DAYS			0	UNSPECIFIED

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125762074	12576207	1	Hepatitis C
125762074	12576207	2	Hepatitis C
125762074	12576207	3	Hepatitis C

Outcome of event

Event ID	CASEID	OUTC COD
125762074	12576207	OT

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
125762074	12576207		Drug ineffective
125762074	12576207		Hepatitis C

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
125762074	12576207	1	201502
125762074	12576207	2	201502
125762074	12576207	3	201502