Safety Rates Drug Report: adverse events in 2016 Q1 - 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
105291948	10529194	8	F	2014	20160322	20141020	20160331	EXP	FR-ANSM-PV20140326	FR-GILEAD-2014-0118805	GILEAD		58.00	YR	A	M	Y	74.00000	KG	20160331		OT	FR	FR

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
105291948	10529194	1	PS	SOFOSBUVIR	SOFOSBUVIR	1	Oral	400 MG, QD	204671	400	MG	TABLET	QD
105291948	10529194	2	SS	DACLATASVIR.	DACLATASVIR	1	Oral	90 MG, QD	0	90	MG		QD
105291948	10529194	3	C	EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE/EFAVIRENZ		2	Oral	1 DF, QD	0	1	DF	TABLET	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
105291948	10529194	1	Hepatitis C
105291948	10529194	2	Hepatitis C
105291948	10529194	3	HIV infection

Outcome of event

Reactions reported

Event ID	CASEID	PT
105291948	10529194	Arrhythmia
105291948	10529194	Atrioventricular block complete
105291948	10529194	Bradycardia
105291948	10529194	Bundle branch block
105291948	10529194	Conduction disorder
105291948	10529194	Syncope

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
105291948	10529194	1	20140829	201502
105291948	10529194	2	20140829	201502
105291948	10529194	3	2005