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
126549031	12654903	1	I	20151002	0	20160815	20160815	DIR					70.00	YR		M	N	97.50000	KG	20160720	N	PH	US

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
126549031	12654903	1	PS	CETUXIMAB	CETUXIMAB	1	Intravenous (not otherwise specified)				Y	D			0	890	MG		1X

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126549031	12654903	1	Neoplasm malignant

Outcome of event

Reactions reported

Event ID	CASEID	PT
126549031	12654903	Acidosis
126549031	12654903	Dizziness
126549031	12654903	Hypercapnia
126549031	12654903	Hypoxia
126549031	12654903	Nausea
126549031	12654903	Pulmonary oedema
126549031	12654903	Respiratory failure
126549031	12654903	Tachypnoea

Reporting Sources (this data is often not reported and may therefore be missing here)

Event ID	CASEID	RPSR COD
126549031	12654903	HP

Therapies reported

Event ID	CASEID	DSG DRUG SEQ	START DT	END DT	DUR	DUR COD
126549031	12654903	1	20151002	20151002	0