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
84611529	8461152	9	F	20120225	20160914	20120315	20160922	EXP		CA-ROCHE-1048223	ROCHE		66.36	YR		M	Y	0.00000		20160922		MD	CA	CA

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
84611529	8461152	1	PS	XOLAIR	OMALIZUMAB	1	Subcutaneous				U		S0060,S0061D		103976	225	MG	SOLUTION FOR INJECTION
84611529	8461152	2	SS	XOLAIR	OMALIZUMAB	1	Subcutaneous				U		S0060,S0061D		103976

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
84611529	8461152	1	Asthma

Outcome of event

Event ID	CASEID	OUTC COD
84611529	8461152	OT
84611529	8461152	HO

Reactions reported

Event ID	CASEID	PT
84611529	8461152	Arthritis
84611529	8461152	Asthenia
84611529	8461152	Blood pressure increased
84611529	8461152	Concussion
84611529	8461152	Contusion
84611529	8461152	Fall
84611529	8461152	Fatigue
84611529	8461152	Headache
84611529	8461152	Hypotension
84611529	8461152	Hypothermia
84611529	8461152	Insomnia
84611529	8461152	Loss of consciousness
84611529	8461152	Productive cough
84611529	8461152	Sputum discoloured
84611529	8461152	Swelling

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
84611529	8461152	1	20120112		0
84611529	8461152	2	20160316		0