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
113605023	11360502	3	F	20150312	20160715	20150810	20160721	EXP		PHEH2015US005389	NOVARTIS		37.49	YR		M	Y	0.00000		20160721		CN	US	US

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
113605023	11360502	1	PS	EXTAVIA	INTERFERON BETA-1B	1	Subcutaneous	WEEKS 1-2: 0.062 MG, QOD (0.25 ML IN 1 TO 2 WEEK)	125290	.25	ML	SOLUTION FOR INJECTION
113605023	11360502	2	SS	EXTAVIA	INTERFERON BETA-1B	1	Subcutaneous	WEEKS 3-4: 0.125 MG (0.5 ML), QOD	125290	.5	ML	SOLUTION FOR INJECTION
113605023	11360502	3	SS	EXTAVIA	INTERFERON BETA-1B	1	Subcutaneous	WEEKS 5-6:0.1875 MG (0.75 ML), QOD	125290	.75	ML	SOLUTION FOR INJECTION
113605023	11360502	4	SS	EXTAVIA	INTERFERON BETA-1B	1	Subcutaneous	WEEKS 7+: 0.25 MG (1 ML), QOD	125290	1	ML	SOLUTION FOR INJECTION

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
113605023	11360502	1	Multiple sclerosis

Outcome of event

Event ID	CASEID	OUTC COD
113605023	11360502	OT

Reactions reported

Event ID	CASEID	PT
113605023	11360502	Central nervous system lesion
113605023	11360502	Drug prescribing error
113605023	11360502	Incorrect product storage
113605023	11360502	Injection site erythema
113605023	11360502	Injection site mass
113605023	11360502	Injection site pain

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
113605023	11360502	1	20150312		0