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
127456451	12745645	1	I		20160823	20160915	20160915	EXP		US-ROCHE-1828653	ROCHE		56.00	YR		F	Y	92.10000	KG	20160915		MD	US	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
127456451	12745645	1	PS	Bevacizumab	BEVACIZUMAB	1	Intravenous (not otherwise specified)	COURSE 1			U				125085	2100	MG
127456451	12745645	2	SS	TEMSIROLIMUS	TEMSIROLIMUS	1	Intravenous (not otherwise specified)	COURSE 1			U				0	100	MG

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127456451	12745645	1	Malignant neoplasm of islets of Langerhans
127456451	12745645	2	Malignant neoplasm of islets of Langerhans

Outcome of event

Event ID	CASEID	OUTC COD
127456451	12745645	OT

Reactions reported

Event ID	CASEID	PT
127456451	12745645	Aspartate aminotransferase increased
127456451	12745645	Atrial tachycardia
127456451	12745645	Dehydration
127456451	12745645	Fatigue
127456451	12745645	Hypertriglyceridaemia
127456451	12745645	Lower gastrointestinal haemorrhage
127456451	12745645	Nausea
127456451	12745645	Neutrophil count decreased
127456451	12745645	Rash maculo-papular
127456451	12745645	Upper gastrointestinal haemorrhage
127456451	12745645	Vomiting

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
127456451	12745645	1	20091231	20111117	0
127456451	12745645	2	20091231	20111117	0